Medical Affairs Resume Samples

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I Stanton

Ignacio

Stanton

50540 Trinity Knolls

Boston

+1 (555) 117 8983

50540 Trinity Knolls

Boston

Phone

p +1 (555) 117 8983

Experience Experience

Phoenix, AZ

Medical Affairs

Phoenix, AZ

Kunde, Jenkins and Emard

Phoenix, AZ

Medical Affairs

Assists Scientific Lead and/or Disease Lead in making recommendations, taking action and providing clinical research input related to projects
Perform ongoing resolution of issues arising from patient clinical management e.g. patient eligibility and study conduct
Develop innovative research concepts for clinical data generation; provide relevant scientific and technical training
Attend relevant conferences and scientific meetings to maintain and develop a network of contacts with specialists and customers
Provide internal training for Therapeutic Area as requested
Assist with all elements of new product launches requiring scientific expertise
Develop and maintain relationships with key opinion leaders across EUCAN

San Francisco, CA

VP, Medical Affairs

San Francisco, CA

Nitzsche, Moen and Heathcote

San Francisco, CA

VP, Medical Affairs

Builds medical affairs infrastructure, including publications management and review process, and unsolicited medical request tracking and management system
Serves as a key member of SPS’ Executive Leadership Team, providing strategic direction related to the development and expansion of clinical services
Formulates and implements operational strategies and initiatives, including patient safety, performance improvement and physician recruitment
Communicate and collaborate with commercial colleagues for the development of marketing and lifecycle management strategies
Provides leadership to management within areas of responsibility
Assists in evaluating new business opportunities by actively engaging in strategic planning for business plan development
Oversees SPS’ Wellness Program, providing key clinical expertise and working with 3rd party vendors

present

Chicago, IL

Director of Medical Affairs

Chicago, IL

Hammes-Rice

present

Chicago, IL

Director of Medical Affairs

present

Manage the Medical Affairs department and provide leadership, direction, coaching, mentoring and general management for the respective staff
Establishes the regional medical affairs network and provides strategic leadership to the local and regional medical teams
Work with the biostatistics team to develop statistical analysis plans of internal and collaborative studies
Develop and manage interactions with investigators of collaborative studies
Develop framework for and implement outcomes studies that will demonstrate the impact of the PharMEDium portfolio
Create stronger alliance and more consistent dialogue between the MSLs and the Clinical Development Unit
Develop a business plan and timeline for the creation and oversight of a team of Medical Liaisons to serve as field based clinical and business specialists

Education Education

Bachelor’s Degree in Health Sciences Related

Colorado State University

Bachelor’s Degree in Health Sciences Related

Skills Skills

Ability to work independently with good organizational skills
Should be able to multi-task, prioritize assignments and be able to complete given tasks on a daily basis
Understand ICH guidelines for good clinical practice (GCP) in relation to clinical trial conduct
Experience in overseeing work of other professional staff
Physician practice management or care coordination experience
Strong strategic thinker and problem solver, with results oriented focus
Experience in negotiation and conflict resolution
High tolerance for complex, ambiguous and constantly changing environment
Strong customer service skills and patient centered attitude
Reads, writes, speaks, and comprehends English

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15 Medical Affairs resume templates

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Medical Affairs Country Head Resume Examples & Samples

Oversee and provide direction for the Medical Affairs area of the Mexican affiliate
In conjunction with marketing and Area Directors, develop the Mexican KOL strategy, then establish and maintain professional, peer-type relationships with key opinion leaders (KOLs) and other key customers in each of the therapeutic Areas
Provide professional leadership for the medical/scientific aspects of Shire Rare Diseases Mexico symposia, workshops, satellite symposia and other meetings, including speaker contacts, and post-conference publications
In conjunction with marketing, develop and execute a publication plan to support key marketing strategies
Where appropriate, contribute to the design of Shire Rare Diseases sponsored Phase IIIb and Phase IV clinical trials consistent with the marketing strategy and publication plans
In conjunction with marketing and Area Directors, manage interactions with Mexican physicians with respect to clinical research grants and other post-marketing programmes
Provide medical input to Mexican sales and marketing strategies
Review and approval of the medical aspects of Mexican promotional and other materials
Review of current literature, providing relevance to our products and markets
Contribute to the wider Global Medical Affairs group ensuring knowledge sharing and optimization
Assist with the training of Shire Rare Diseases personnel on Medical aspects of the business
Oversee implementation of and medical approval for appropriate compassionate use programmes
Manage the Argentinean research and education grants budget
A Medical Doctor with 3-5 years experience in Mexican Medical Affairs in the Pharma/Biotech industry

Head of Medical Affairs Resume Examples & Samples

70% - Lead and develop the Global TA Medical Affairs team (includes US TA Medical Affairs)
Define TA global medical strategy, appropriately aligned with overall BU, PST and Development team strategy (as appropriate)
Responsible for multi-year TA medical performance and strategy
Responsible for in-year implementation of TA medical plans in the US
Oversight of the International Medical Affairs’ in-year implementation of TA global medical plans
Maintain a high level of expertise through familiarity with clinical practice, treatment standards and medical and scientific literature within the TA
Define and request required budget and TA/Functional/Regional resources in collaboration with GMA leadership
Oversee utilization of TA budget and resources
Coordinate with Head of Shared Medical Services (SMS) to ensure TA GMA teams are trained and supported as appropriate
Coordinate with International Medical Head (IMH) to ensure TA is appropriately supported across regions and countries and local teams are appropriately trained and resourced
Collaborate with Legal, Compliance and Regulatory to establish and ensure proper and ethical conduct of TA GMA personnel across all activities
Establish appropriate strategic partnerships with Key Opinion Leaders, Centers of Excellence and professional medical societies in areas of scientific interest within TA
Establish and tracks appropriate performance metrics at the TA and product/disease area levels
Act as a senior company representative interacting with external scientific leaders, patient advocacy groups and/or regulatory authorities
Assist with assessments, intelligence and due diligence activities on potential new products relevant to TA
Serve as the GMA lead on the BU leadership team to help determine BU strategy and coordinates ongoing R&D activities for TA products in conjunction with other R&D functions as appropriate
10% - Member of GMA Leadership Team (GMALT)
Participate in GMA Leadership Team definition of GMA strategy
Oversee implementation of Global Medical strategies and plans
Represent GMA at various internal and external forums
10% - Mentoring, training and performance management
Perform routine performance and talent reviews
Identify and address training and development needs for TA team
Mentor and support team members managing other team members
10% - Establishment and maintenance of a compliant environment
Coordinate with Legal, Compliance, PV and Regulatory to ensure appropriate systems, processes and training is in place in TA team
>10 years of experience in biopharmaceutical medicine, preferably within a matrix structure is required
Experience in designing and conducting registrational or phase IV studies is required
Experience leading teams at the brand or disease area levels in country, regional and / or global organizations is required
Experience leading field teams is preferred
Experience in specific therapeutic areas through clinical experience or biopharmaceutical industry experience is preferred

Director of Medical Affairs Resume Examples & Samples

3+ years of Clinical or Managerial experience in the Biopharmaceutical industry or equivalent experience
MD, PhD or PharmD
Radiology/contrast media experience
Board certification in Radiology or MR
Experience in Pharmaceutical Trial design and conduct (Phases II-IV) within the pharmaceutical industry, Contract Research Org or academia
Demonstrated ability to work in a matrix type environment with interaction with cross-functional teams

Country Medical Affairs Lead-gi / Im-br Resume Examples & Samples

A Medical Doctor with Specialization degree
At least 3 years of experience in Medical Affairs in the Pharma/Biotech industry
Medical Doctor with a minimum of 5 years experience in Latin America Medical Affairs in the Pharma/Biotech industry
Portuguese and English fluent

Medical Affairs Mgr, Renal, SEA Resume Examples & Samples

MD Pharmacology/Clin Pharmacology/Medicine/ MS (in any surgical) branch will be preferred
2-4 years of medical affairs experience desired in a reputed pharmaceutical/ healthcare company
Prior experience of working with Physicians (Nephrology) in SEA will be desired
LI-AR

Head Oncology Medical Affairs Resume Examples & Samples

A minimum of 7 years pharmaceutical industry experience is required
Oncology experience is required
Historic clinical practice in oncology is highly preferred

Medical Affairs Program Manager Resume Examples & Samples

Responsible for oversight and management of Medical Education Grant request and Investigator-Initiated Trials
A minimum of 5 years of experience in the biopharmaceutical industry with overall 8-10 years of working experience, preferably within a matrix organization
Extensive experience utilizing Cyber Grants and other web-based grant Ability to balance excellent customer service skills with strict compliance requirements
Effectively organize, prioritize, and manage multiple projects in a fast paced environment
Experience General understanding of Medical Education/Pharmaceutical Industry guidelines (OIG, ACCME, and PhRMA) and regulations
Ability to prioritize, stay organized and meet deadlines, even under pressure or time Good understanding of clinical research science and processes as well as global clinical trial regulations is required
Ability to collaborate across different functional areas to ensure alignment with governance processes and to meet business objectives is required
Drug forecasting experience and knowledge of drug development process, FDA, ICH, and GCP guidelines preferred
Ideal candidate also has previous experience with training new employees and team mates

UK Medical Affairs Lead-rheumatology Resume Examples & Samples

Full responsibility for defining the Medical strategy and priorities for the team and ensuring delivery against that plan
Be a key contributor to the Brand plan and other key commercial initiatives as required
Monitor the environment for competitive intelligence and develop summaries of key messages for use within the Company
Review and prepare promotional material ensuring the medical/scientific content is correct and fully compliant with both external and internal policies and guidelines
Line management of Rheumatology team including second line management for in-field team
Develop and maintain therapy area expertise through participation at key meetings, congresses and seminars as well as self-study
Provide expert medical/scientific advice including responding to requests for information; contribute to the development and accuracy of core dossiers generated by Medical
Establish and maintain professional and credible relationships with KOLs and academic centres through participation in scientific congresses, coordinating advisory boards, round-table meetings, discussion fora etc
Create and deliver scientific presentations, sales training and medical education programs to a range of internal and external audiences
Design, implement and oversee clinical research projects within defined standards and budgets (e.g. Phase IV, registry/database projects, epidemiological surveys, PMOS studies)
Support the affiliate Clinical Research Department in the management of clinical studies, as appropriate (e.g. review new clinical study protocols, identifying potential investigators/sites, conducting feasibility surveys)
Previous proven Medical Affairs experience including copy approval, running IIS/IITs, ad boards, symposia, KOL development activities, etc
Final Signatory would be an advantage but is not necessary - experience of working with the ABPI and PMCPA is needed
Experience of working with Brand teams and inputting into Brand Plans
Able to work collaboratively and influence widely
Oncology experience would be preferred

VP, Medical Affairs Resume Examples & Samples

Develops medical affairs strategies, policies and tactical plans consistent with customer and patient needs and corporate goals and objectives
Leads all data and clinical publication activities on Adamas’ investigational medicine ADS-5102
Develops meaningful phase 4 clinical trial strategies, consistent with product life cycle management plan, and leads such clinical trials, including protocol development
Designs and implements a health economics and outcomes research (HEOR) plan (e.g., generates and publishes relevant pharmaco-economic data), participates payer organizations engagements, and partners with the managed markets and access teams
Manages key external partners, including medical information and medical safety
Holds partners accountable for timely and quality deliverables, within budget
Builds, manages, mentors, and effectively leads the medical affairs team. Provides feedback, coaching and professional development opportunities for direct reports
Builds medical affairs infrastructure, including publications management and review process, and unsolicited medical request tracking and management system
Partners with the commercial team to ensure all marketing and sales deliverables are clinically accurate and scientifically sound
Represents the company at external forums and medical congresses as necessary, and appropriately interacts with opinion leaders, investigators, and other advisors
Ensures compliance with corporate policies and procedures, as well as, US healthcare laws and regulations
MD or PharmD required, with board certification
Minimum 10-years of medical affairs experience in the biopharmaceutical industry (large and/or small companies)
Recent launch experience, ideally in the CNS space
Track record of

Senior Director, Field Medical Affairs Resume Examples & Samples

Defines strategic direction for Field Medical Affairs and ensures alignment with corporate and commercial initiatives
Direct management responsibility for the AMAG Medical Science Liaison team including recruiting, hiring, and retaining qualified candidates
Provide regular field updates and insight to internal stakeholders in home office
Development, execution and maintenance of MSL SOP’s; develops metrics to track success of MSL team
Ensure the MSL team is deployed appropriately to support the field commercial organization
Manage administrative aspects of the team including review and approval of expense reports, timesheets, and database entries
Ensure seamless integration with other AMAG field roles via regular communication with other field leadership
Provide appropriate mentoring and coaching to direct reports with respect to technical skills, business acumen/planning, and effective regional management
This role requires close interdepartmental collaboration and alignment of goals and objectives of Field Medical Affairs, with our Commercial counterparts as well as our key strategic partners. The Executive Director, Field Medical Affairs will be a key interface for internal and external stakeholders
Doctoral degree (PhD, PharmD, or MD) is required
Minimum of 10 years in Medical Science Liaison and 5+ years of management experience
Experience in nephrology, hematology, oncology and a well-established KOL network is strongly preferred
Proven track record of success, especially in the areas of thought leader engagement, territory planning, and integration with other field roles
Successful record of managing large and complex projects with minimal oversight
Ability to travel across assigned area. Estimated travel 40%

Program Manager, Eveo & Field Medical Affairs Resume Examples & Samples

Operational functions include
An undergraduate degree with 7-10 years or a graduate degree with 3-5 years of pharmaceutical industry experience in operations and/or project management
Understanding of the regulatory compliance framework within which Medical Affairs operates
Advanced scientific, technical reading, writing, and editing skills
Ability to prioritize activities, manage multiple tasks within deadlines, and act with minimal supervision
Strong ability to work collaboratively within a highly matrixed work environment
Detail-oriented with excellent written and oral communication skills
Proficient word processing and PowerPoint skills

Medical Affairs Executive Resume Examples & Samples

Provide Medical Affairs and Information support for the assigned products
Prepare disease and product training materials for marketing and sales team
Achieve timely and successful product registrations in accordance with Corporate, Regional, and Local strategies
Maintain the regulatory position of registered/marketed products and carry out variation submissions according to company and regulatory authority requirements
Responsible for product release into market and product complaint / recall handling
Act as co-ordinator for Healthcare Compliance related activities

Ropu CHC Medical Affairs Resume Examples & Samples

Develop, implement and execute strategies and activities to bring the benefit of BI medications to patients across the product lifecycle
Operate in cross-functional teams (Marketing & Sales,Business Development, Regulatory Affairs, Pharmaco-vigilance and other functions)
Maximize drug commercialization efforts from a medical perspective, lead the regional team to profile the safety and efficacy of BI medications through communication of medical meaningful messages, sound up-to-date medical information, local generation and communication of relevant clinical efficacy/safety data, and scientific exchange with external experts
Develop, execute or oversee scientifically relevant and innovative regional Medical Affairs programmes such as clinical studies, non-clinical activities (databases, in vitro/ ex vivo studies, publications or programmes with external experts
Develop and maintain medical expertise for the relevant BI products and therapeutic areas CHC to meet internal customers/ external consumers needs, in combination with a thorough understanding of Marketing & Sales strategies/tactics

Head of Medical Affairs Resume Examples & Samples

Responsible for directing and managing the US Medical Affairs team in hematology & oncology, including MSLs and US Disease Teams with ownership and accountability to drive US Medical Affairs programs and related processes
Provide inspirational leadership and focus to US Medical Affairs team and ensure delivery of US Medical Affairs goals and objectives as related to Global Medical Affairs and corporate objectives in a highly dynamic environment. Develop and own career ladders for the various functions within US Medical Affairs
Responsible for management of US MSL field force, including training department; setting goals and objectives for field force; developing and improving performance metrics and measures of customer satisfaction; sizing of field force appropriate for new drug launches and/or indications. Prioritize MSL activities across diseases and indications. Develop MSLs for payer presentations and to support translational efforts of CRD trials
Oversee the US IIT process, from receipt of proposals through approval, including IRC approval process, budget negotiation, contracts, and study execution. Manage operations team to handle all aspects of US IIT program. Develop US open data questions in close collaboration with global disease teams, market access, and marketing. Work closely with corporate Medical Affairs and IT to implement databases and processes to manage US IIT program
Responsible for the management of the departmental budget and workforce plan under SVP oversight
Oversee the conduct of US Medical Affairs Sponsored Trials (MAST)
M.D. and/or Ph.D. degree with extensive work experience in the areas of hematology and/or oncology. US medical training and direct patient care experience preferred
Minimum 10 years increasing executive management experience in Medical Affairs/Clinical Development in the pharmaceutical industry with demonstration of successful results
Minimum 10 years of experience in pharmaceutical industry, with experience managing a field force (Medical Science Liaisons)
Product lifecycle management experience highly preferred
Clinical trial experience in Clinical Research and Development as well as in Medical Affairs preferred
Good understanding of Medical Affairs and comprehensive understanding of the compliance issues concerning MA function
Creation and management of successful cross-functional and multi-disciplinary teams in changing competitive

Medical Affairs Resume Examples & Samples

Review and provide input to the protocol synopsis, and protocol, and develop the master Informed Consent Form, according to the Clinical Development Plan and as approved by the Hematology and Oncology Development Committee for Interventional Clinical Trials or by the Medical Affairs Independent Review Committee for Non-Interventional Post Authorisation Safety Studies (NI-PASS) and Non-Interventional Post Authorisation Efficacy Studies (NI-PAES)
Review and provide clinical input to the Statistic Analysis Plan, Monitoring Plans, Risk Management Plan, Case Report Forms (CRFs), edit specifications/checks, CRF completion guidelines, Study Charters and relevant regulatory documents, as required
Lead the development of the Clinical Data Review Plan (CDRP), collating input from all relevant functions, and lead meetings thereof
Ensure that clinical study milestones are aligned from a clinical/scientific perspective and consistent with the clinical program or regulatory authority expectations for NI-PASS and NI-PAES
Select countries, identify prospective sites and contribute to the selection of the final sites, in collaboration with the Medical Lead
Address any clinical / scientific issues arising from regulatory authorities and ethics committees
Participate in the selection and assessment of study vendors
Identify membership and provide input into the charters of the Data Monitoring Committee (DMC), Steering Committee (SC) and other committees as required, in collaboration with the Medical Lead
Participate and Present at external Investigator Meetings and at internal meetings
Support the study team with scientific expertise at study site initiation and subsequent motivational visits, as required
Perform ongoing resolution of issues arising from patient clinical management e.g. patient eligibility and study conduct
Provide input into safety data reconciliation
Review data in an ongoing manner, i.e., safety, primary efficacy variables (where applicable), laboratory data and coding issues. Identify trends and follow up on any clinical issues/ discrepancies to be addressed to the sites
Participate as a key meeting contributor in the DMC, SC, Risk Management and any related meetings, as appropriate
Review and provide input into Clinical Study Reports and relevant clinical sections of the Investigator Brochure, as required
Review, provide input, and lead clinical update of annual IND report and Periodic Safety Update Reports (PSURS), as required
Act as Study Manager/Back Up Study Manager for Celgene Sponsored Studies (non-interventional or interventional) on occasions as needed
LI-SL1

Medical Affairs Heor Director Resume Examples & Samples

Training and education of Internal and External Medical professionals, across EMEA, on the data, the economics and QoL impact for patients & physicians (HEOR Academy)
The generation of evidence and data from clinical trials (Med Aff, IITs and other Real World studies) from a Medical perspective which complements and reinforces the Pricing and Value driven evidence from Market Access analysis
EFPIA Company lead for WP6 (Policy Makers, HTA Agencies, Payers, Patients) for a pan EU Innovative Medicines Initiative (HARMONY). HARMONY - Healthcare Alliance for Resourceful Medicines Offensive against Neoplasms in HematologY - is aimed at capturing, integrating, analyzing and harmonizing big data from high-quality multidisciplinary sources with the purpose of unlocking valuable knowledge on various hematologic malignancies. The big data platform will enable the more rapid definition of promising treatment strategies and predictions of adverse events likely to be associated with such strategies. This is a five year project with a total budget of E 40 million
Establishing a clear Medical Affairs perspective HEOR strategy with agreed areas of Open Research Questions
Providing Medical based HEOR advice and assistance in generation of value proposals and dossiers for regional reimbursement and payer negotiations
PhD qualification in health economics (desirable) with an MSc qualification in health economics (essential)
Evidence of ongoing study to ensure up to date academic thinking

VP, Medical Affairs Resume Examples & Samples

Recruit and lead top-tier medical affairs talent to serve as leaders and members of the ITCA 650 Brand Medical Affairs Team and Field Medical Affairs team
Develop and execute a comprehensive ITCA 650 Medical Launch Plan that is aligned with the overarching brand plan
Build a high-impact medical and scientific platform, including: scientific exchange and partnership with KOLs, medical communication and publication plans, scientific congress activities, medical education programs, scientific advisory boards, and a post-approval evidence generation plan
Be a “medical voice” and “scientific mind” on the cross-functional Brand Team, in close partnership and collaboration with the Brand Champion
Ensure all activities are conducted with the highest levels of scientific rigor and in full compliance with applicable rules and regulations
Create an energetic, positive, performance-based culture within the Brand Medical Affairs Team and Field Medical Affairs Team that is aligned with the overall Intarcia culture and supports the growth and professional development of every team member
You are obsessed with making a meaningful difference in the lives of people living with serious chronic diseases
You understand the science and business of medicine, and can speak both languages
You have a high level of emotional intelligence along with outstanding ability to lead and inspire others
You can translate concepts and ideas into timely action and high-impact results; you are known for both innovation and execution
You uphold impeccable ethics and unquestionable integrity in all that you do
You are known as both a strong team leader and a cross-enterprise leader
You have strong executive presence, you are able to communicate complex ideas with clarity and concision
You have high energy, a collaborative spirit, and an entrepreneurial mindset
You are comfortable with ambiguity and uncertainty
You have shown the ability to thrive in a small but rapidly evolving organization
You are unwilling to settle for anything less than excellence in yourself and your team
You have a PharmD, PhD, MD, or other doctorate-level scientific degree from a top-tier US institution
You preferably have both research and clinical experience
You have at least 10 years of medical affairs leadership experience in the pharmaceutical, biotechnology or medical device industry, preferably including headquarters and field experience
You have deep scientific knowledge and experience in the area of diabetes and metabolic disease. Alternatively, you have clearly demonstrated the ability to master a new therapeutic area deeply and quickly
You have experience in the evolving healthcare system, with payers, IDNs, or both
You have successfully supported the launch of multiple transformative drugs or devices
You have a strong and consistent track record of success and developing strategy and executing operational plans

Director of Medical Affairs Resume Examples & Samples

Oversee the creation, review of approval and execution of all Medical activities in the 5 focus areas for all NNCI products
In charge of supporting the pre-launch and launch activities and disease awareness initiatives for all NNCI products
Provide input into product life cycle management activities and the development and execution of product-specific plans ensuring high quality and efficient delivery
Create stronger alliance and more consistent dialogue between the MSLs and the Clinical Development Unit
Coordinate the development of Medical Product Plans Pre-launch activities cross-functionally and in alignment with Global Medical Affairs and Global Marketing strategies
Guide the evaluation requests for research grants and investigator-sponsored studies and oversee the ISS Grant Review process in strict compliance with the Global SOPs and the local requirements
Ensure that NNCI remains on track and compliant with all Global Medical Affairs and GMAF requirements and provide any support joint initiatives
Work closely with the VP of CMR and other partners to proactively identify areas of further organizational development and infrastructure enhancements in alignment with the CMR direction
Manage the Medical Affairs department and provide leadership, direction, coaching, mentoring and general management for the respective staff
Closely manage and track several budget lines simultaneously representing the main bulk of CMR activity budgets
A Doctoral Degree in Medicine and/or a PhD in health sciences. A specialization or specialized experience in Endocrinology with focus in Diabetes and Metabolic diseases with some focus on Obesity is strongly preferred
10 years’ experience in the pharmaceutical or biotech industry including expertise in clinical trial methodology, product development plans, and familiarity with the basics of clinical research designs, ethics in healthcare and legal/ regulatory environment
7 years in a leadership role within Medical Affairs with a minimum of 5 years in the capacity of Head Manager, with a proven track record of success in leading Medical Affairs organizations
Advanced business education and leadership development will be prioritized
Experience in a clinical practice environment, 3-4 years of research experience, solid scientific experience as indicated by publications of scientific papers in peer-reviewed journals or equivalent
Strong business acumen, leadership, communications, interpersonal and organizational skills are crucial to success in this role

Head Medical Affairs Diabetes & Cardiovascular Resume Examples & Samples

Support the Canadian initiative for DCV thought leader advocacy and relationship-building. The Medical head is responsible for cultivating current and future experts in academic and clinical medicine at regional and national levels. Through these relationships, the team will gain meaningful expert insights that influence priority areas of the product Life Cycle Planning team in support of business, clinical and scientific strategy
Liaise regularly with internal business leaders to share feedback and issues from the disease area experts
Support the development of Investigator sponsored studies. Through expert relationships, the Medical head will ensure and facilitate the initiation of research projects and ensure that hypothesis testing is clearly defined and within priority areas consistent with the strategic development objectives of the portfolio of products. He/she will be responsible to ensure the successful execution of appropriate processes for review, approval, management and support of studies while maintaining investigator independence according to regulatory and compliance guidelines
Ensure the strategic and substantive input to publication planning and execution to ensure that all data on the portfolio of products generated by company or investigator sponsored trials is publicly presented in an appropriate and timely fashion and in a fair and balanced manner
In anticipation of product launch, the Medical head will ensure that he/she and his/her team provide medical support, education and guidance to commercial, marketing and sales teams. Provide medical support to promotional and legal review committees as needed
Represent Sanofi DCV at medical meetings, conferences, advisory boards, outreach meetings at key institutions, and in interactions with thought leaders
Maintain knowledge of the respective disease area market place, stay current on leading edge products development and lifecycle management efforts and provide perspective to the business on the treatment landscape
Define and develop needs analyses for the Medical Advising, Communication and Medical Science Liaison (MSL) functions, for the respective portfolio to ensure that those carrying out these function activities are optimally educated to be experts on the respective disease areas and the competitive landscape
The Medical head will ultimately, via opinion leader network relationships, ensure the initiation of research projects within priority areas as determined by the product Life Cycle in support of business, clinical and scientific strategy
Through an integrated and cross-functional approach, ensure that medical projects are developed and executed that support maximizing the lifecycle opportunities for the respective products through enhanced value offering including line extensions and new patient access opportunities
Responsible for the development of a local medical plan to optimize commercial success of sanofi DCV products and value offering to patients
Ensure the contribution of Medical Affairs in the development of market access strategy and submissions for DCV products
In collaboration with Clinical operations optimize performance of clinical studies and appropriate management of operational budgets
Ensure adequate medical support to regulatory affairs and pharmacovigilance
Ensure optimal support to Business Development activities, especially by providing the necessary expertise to allow accurate scientific evaluations of opportunities
At least ten years of experience in the biotech or pharmaceutical industry in Medical Affairs, with experience working with cross-functional in-house and with field-based teams
Experience leading and managing a Medical Advisor or MSL team
Forward-thinking and strong knowledge of strategic interplays that influence patient and payer decisions
Ability to work with and effectively support cross-functional teams
Proficiency in public speaking
Strong results orientation i.e. has a proactive, business-oriented focus with the resolve to set challenging goals and demonstrate the commitment and persistence to achieve them
Strong customer focus / orientation
Strategic acumen and negotiation skills
Strategy agility and strong business acumen
Organizational agility and managerial courage

MS Head, North American Medical Affairs Resume Examples & Samples

Board certified M.D., preferably a neurologist working in MS
Extensive work experience in corporate medical affairs (10 years) required
Experience in clinical development, health economics, market access would be ideal
Well established leadership skills, management in attracting, mentoring and retaining high performing medical affairs professionals
Excellent skills working cross functionally, specifically partnering with the commercial organization
Strong communication skills and an ability to articulate a vision and mission and inspire his/her team on an ongoing basis are required
Internally as well as externally, he/she must be seen as a leader. He/she should lead by example and model collaborative behavior and all other behaviors aligned with the Sanofi Genzyme culture
Excellent communication skills with the ability to build solid working relationships with the commercial organization including the managed markets team, as well as negotiate and influence across cultures

Medical Affairs Specialist Resume Examples & Samples

Position Title: Medical Affairs Specialist
Sector: Janssen
Location: Taipei, Taiwan
Employment Type : Long Term Contractor

Head of Medical Affairs, South Korea Resume Examples & Samples

Responsible for the tactical translation and execution of Medical Affairs strategy and implementation towards ensuring product dispersal, acceptance, growth, and, profitability throughout its life-cycle
DRIVING BUSINESS RESULTS/ PROCESS/ CROSS-FUNCTIONAL COLLABORATION
Responsible for developing in cross-functional teams (with Marketing, Regulatory Affairs, Health Outcome & Pricing, Pharmacovigilance and other functions) strategic guidance to bring the benefit of BI medications to our patients across the compound life-cycle
Responsible for enabling and supporting HP to profile the safety and efficacy of BI medications by focusing on medical information, local generation and communication of relevant clinical data and compliant interaction with different external experts
Responsible for developing and performing Medical Affairs activities; studies, publications or programs with external experts in alignment to the planning process, which includes
Guiding the implementation of or execution of all local Medical Affairs activities
Responsible for ensuring that BI attracts, develops, and, retains experts within and across therapeutic areas in prescription medicines which includes
Supporting knowledge and skill sharing within the CDMQ MA organization
Building relationships with respective functions with the organization
LEADERSHIP/ SUPERVISION
Ensure implementation and compliance to the Performance Management / Talent Management / Compensation Planning / BI People timelines for the year
Ensure that there are development plans for direct reports and that they are being implemented on the agreed timelines
Ensure that talents are properly identified and that they are discussed in the cross validation and succession plans
Ensure that proper coaching is provided during the MAG discussions (midyear, yearend, or whenever the need arises)
Ensure the adequate staffing of the team and the development and movement of talents are properly implemented

Medical Affairs Specialist Resume Examples & Samples

Good administration skills in filing and affairs coordination for routine office duty
1-2 years as CRA or medical technologist background also can be considered
Degree in Nursing/Pharmacy preferred

Head of Medical Affairs, Alcon, Denmark Resume Examples & Samples

Support the objectives of Medical Affairs through strategic leadership of the Country medical associates. Seen as a credible medical expert by internal and external customers
Ensure seamless and optimal collaboration of associates in local country with Regional R&D and Global Teams in execution of local medical activities
Oversee implementation of local country-specific medical programs across Therapeutic Areas within Medical Affairs Franchises
Actively ensure scientific and strategic input into the local Clinical Trial Plan and strategic portfolio management within Medical Affairs through relevant participation on the Protocol Review Committee when required
Provide strategic and tactical guidance for Medical Affairs functions within the country by ensuring strategic alignment of all Medical Affairs projects performed locally with the region in relation with the global strategy
Ensure optimal safety and clinical overview is provided by associates in all activities in scope within Medical Affairs, as relevant
Develop and maintain relationships with KOLs and investigators in clinical studies within Medical Affairs in a collaborative and transparent manner
Provide medical resources in the active collaboration with Marketing, as appropriate per SOPs, ethical and corporate compliance guidelines and local country laws to ensure integration of all Medical Affairs activities within the country in order to drive efficiency
Responsible for Medical Affairs in ensuring local adherence to Medical Review of Promotional Materials and other approval processes
Coordinate successful development of external contacts (KOLs, influencers, key external customers / investigators, academic and regulatory community when medical presence is required) across Surgical and Vision care Franchises, and collaborate with other Medical Affairs local colleagues to meet customer needs
Ensure dissemination of trial-generated medical information within Medical Affairs to educate key influencers, including scientific and regulatory leaders
Responsible for resource planning and management (FTEs and Phase IV budget) across Sx and VC Franchises within Medical Affairs
MD or PhD (Biomedical Sciences) required, with preferebly3-5 years’ experience in medical affairs and/or clinical research. Preference for expertise in Medical devices and Ophthalmology
Mandatory Fluent in English & at least 1Nordic Local Language, preferable
Knowledge of the different aspects of medical affairs, clinical research in product development and post-approval research
Knowledge and experience of medical and scientific methodology as well as clinical trial design and data analysis
Tactical Medical oversight for protocol development, including investigator initiated studies and coordination of registries
Publication management and scientific writing
Medical/scientific expertise in review/approval of content of documents for medical accuracy
Demonstrable knowledge of health authority and local regulations to ensure full adherence to compliance requirements
Strong interpersonal skills and the capacity to interact with variety of individuals, KOLs, payers, investigators, health authorities, etc
Expertise in working in a multidimensional matrix environment and ability to manage multidisciplinary/functional medical affairs teams

Werkstudent Medical Affairs Operations Resume Examples & Samples

Administrative support in the tracking and filing of Investigator-Initiated Trials (IITs)
Tracking of IIT patient recruitment, milestones, updates etc. in databases and Excel spreadsheets
Filing of all relevant IIT and non-clinical research documents in document repositories
Regular dispatch of Investigator Brochures/mailings etc. to study sponsor offices
Scanning and archiving of relevant documents for IIT and other studies
Take personal responsibility for the quality of work, meeting required quality and performance standards and completing all assigned tasks in the most efficient and effective manner
Enrolled student of Health Science, Medicine or Natural Sciences
Fluency in German and English, both oral and written
Experience with Windows Office programs (Word, Excel, Power Point)
Willing to do repetitive administrative tasks
Can work within a team and also independently
Flexibility, “Can Do attitude”
Knowledge of clinical drug development/clinical trials would be an asset

Medical Affairs Associate Manager Resume Examples & Samples

Prepare and participate in review of protocol and other study-specific documents such as Clinical Study Reports, Investigator Brochures and regulatory submission documents. Coordinate review/ approvals and translation as needed
Conduct pre-qualification assessments, site initiation, monitoring, and close-out visits (or oversee ESP Site Monitors). Train site personnel to study-specific protocols
Manage and prepare Agreements, purchase orders, site contracts
Actively participate in the evaluation and selection of qualified external service providers (ESP)
Serve as the primary point of contact with ESPs to ensure Sponsor oversight
Ensure that all clinical trials are conducted in compliance with the study protocol, contractual agreements, J&J standards and GCP to ensure patient safety, quality data and accurate study timelines, budgets and quality standards are met
Set-up and proactively maintain Trial Master Files to ensure inspection readiness at any point time
Work collaboratively and cross-functionally (both internal and external to J&J) with Study Director, Clinical team, Healthcare Compliance (HCC), Project Management (PMO), Research & Development (R&D), Clinical Supplies, Regulatory Affairs, Safety, Clinical R&D Quality & Compliance, Procurement, Innovation Teams, Marketing, Principal Investigators/staff and other ESPs
Acquire clinical and pharmacology knowledge of the therapeutic area(s) and compounds under development. Acquire working knowledge of global regulations and guidelines as it pertains to clinical research
Champion operational excellence to provide continuous improvement of processes and sharing of best practices/lessons learned. Suggest ways to reduce complexities of existing procedures
Propose alternative study operation solutions to optimize use of time, cost and resource
Required Fluent English and Advanced Spanish
Good communication skills (both oral and written) and be able to work effectively in cross-functional teams both internally and externally to the organization
Microsoft applications including Word, Excel and PowerPoint
Knowledge of GCP and ICH regulations
Efficient, organized and capable of prioritizing multiple tasks
Willingness to adapt to changing priorities and assignments
Experience supporting regulatory submissions (preferred)
Experience with Vendor Management (preferred)Medical Affairs

Medical Affairs Lead, Respi Resume Examples & Samples

The tactical translation and execution of strategy at the local country level
The maximization of drug commercialization efforts from a medical perspective
For developing, executing or overseeing scientifically relevant and innovative local country MA programs
Supporting knowledge and skill sharing within the Medical Affairs organization

Medical Affairs Leader Resume Examples & Samples

Graduate of an accredited medical school and recipient of M.D. or D.O. degrees or equivalent
Demonstrated experience with developing medical strategies and plans
Demonstrated experience with global opinion leader engagement
Patient-centred but commercially aware, values driven approach
Strong project management skills and extensive experience of managing priority brands
Strong verbal and written communication skills in English
Broad understanding of more than one part of the business i.e. Discovery, Clinical, Regulatory, Medical or Commercial roles
Practical/ working knowledge of the Brand and Disease Area - Oncology - (Lung or Solid Tumor experience)

Medical Affairs Physicians Resume Examples & Samples

MD, DO or equivalent
Practical/ working knowledge of the Brand and Disease Area. This could include: respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines
Demonstrated experience in developing medical strategies and plans
Experience with global OL engagement
Demonstrated leadership capabilities
Demonstrated project management skills to lead cross functional teams
Ability to translate data into a strategic medical plan
Proven ability to engage, influence and build effective relationships with OLs, across functional and geographic boundaries

Head, Medical Affairs Resume Examples & Samples

Drive the diverse franchise growth agendas by providing/overseeing strategic medical expertise and input, and by focusing and aligning resources with key priorities in the region with other functions and Corporate groups
Develop cross-functional medical strategy aligned with, and supportive of, commercial strategy. Partner with commercial functions to provide strategic medical insights to shape the portfolio strategy
Own key interfaces wth the Global Medical Affairs organization
Actively oversee the development and implementation of high-quality medical affairs plans, and provide oversight to ensure compliance with all relevant internal policies and external regulations
Actively oversee the design, conduct, analysis and reporting of Medical Affairs clinical trials. Ensure timely submission and delivery of high-quality clinical trial documentation, implementation and execution, in compliance with all relevant SOPs and regulations
Establish relationships with national stakeholders (medical experts, medical societies and managed care organizations). Create, channel and focus the work product of scientific advisory boards
Provide strategic input to and medical due diligence for business development and licensing
Ensure operational efficiency and effectiveness of all aspects of the Medical Affairs organization. Efficiently manage budget and headcount, prioritizing highest impact opportunities
Support the ongoing education of the medical community by overseeing the funding independent CME programs, presiding over scientific operations and appropriately responding to unsolicited requests
Represent Sandoz with professionalism, credibility and integrity at all internal/external meetings
Appropriately manage risk, and provide guidance and counsel to associates and stakeholders to assure all activities are conducted with the highest standards of ethics and compliance, and according to legal and regulatory requirements
At least 12 years of experience in progressively senior roles within clinical development and medical affairs in the biotech or pharmaceutical industry, where evidence of personal contribution and success is clear
Depth of knowledge and experience in clinical strategy development, trial methods and operations
A strong understanding of “good promotional practices” as defined by PhRMA, OIG and ABPI Guidelines, and of independent medical education as defined by ACCME
Demonstrated managerial competence as a functional manager. Prior line management experience/track record of managing medical teams experience is strongly preferred
Business acumen and market knowledge is required. Must possess a thorough understanding of the US market, competitive landscape, customers and other stakeholders
Leadership Capability. Able to achieve organizational focus on key priorities; delegates and effectively builds talent within an organization through guidance and mentorship. Innovative and creative “out of the box” thinker who will challenge the status quo to improve operations and facilitate positive change. Highly committed to developing and retaining high performance teams. Flexible and able to proactively manage a high change environment
Collaboration Skills. A strong team player with highly attuned interpersonal skills, strong team building motivational, collaboration and influencing skills necessary to achieve desired outcomes in a matrix, cross-functional environment. Works effectively in a global, team-based organization. Exercises influence at senior levels, and builds alignment around goals and objectives. Readily builds consensus and achieves agreement on key priorities
Other Personal Characteristics. High integrity, honest with the highest ethical standards. A passionate team player with low personal ego, willing to be a hands-on “working executive.” A personal presence, maturity and style to be effective in cultivating and maintaining relationships
Ability to work independently in fast paced environment
Excellent written and verbal communication skills. Able to design compelling rhetoric
Ability to communicate scientific and clinical information clearly and credibly

Assoc Dir, Medical Affairs Resume Examples & Samples

Advanced degree (i.e., MPH, MS, PhD, MD or PharmD) in a biosciences discipline required
>5 years work experience in medical communications in pharma industry, including medical communication planning
Experience within other medical affairs roles (Medical Scientific Liaison, Medical Information, etc.) is an asset
Experience interacting with vendors and managing budget
Prior experience in the hematology area is preferred
Excellent verbal and written communication skills. Able to present, discuss and communicate medical and scientific data in English
In-depth knowledge of applied tools and systems
Strong analytical & problem solving skills, able to integrate complex and large data sets into written communication
Strong scientific background with a good understanding of clinical research and bioscience methodologies
Understanding of the pharmaceutical commercialization process and knowledge of the legal and regulatory guidelines affecting promotion of prescription products
Understanding of pharmaceutical drug development and of scientific communication across the product life cycle
Good knowledge of pharmaceutical regulations in key markets
Knowledge of scientific platform development, publications, congresses and advisory boards desired

Assoc Dir, Medical Affairs Resume Examples & Samples

Training/Previous work experience
Doctoral level training required (MD, PhD, Pharm.D. or equivalent)
Good understanding of critical processes in R&D in pharmaceutical environment (e.g. drug development and approval, clinical trials and investigator-initiated trial processes)
In-depth knowledge of pharmaceutical regulations in the US
8-10 years of relevant experience and leadership expertise in Medical Affairs preferred

Medical Affairs, Hematology Resume Examples & Samples

Actively participates in advancing and communicating corporate and GMA philosophy and agenda. Participates as a member of TA Management. Coordinates induction, mentoring, training, and development of team. Identifies training needs. May supervise 2-10 employees, including other MDs or PhDs. Responsible for all aspects of talent management for own team and provides feedback as part of TA management. May assist in developing/mentoring junior medical affairs staff
Participates in design and execution of clinical trial safety, product safety and risk management plans. May also carry responsibility for routine and adhoc safety monitoring reports to regulatory agencies. May review, assess and report applicable Adverse Events (AE’s) and Serious Adverse Events (SAE’s) if assigned to AbbVie conduct on clinical studies
All clinical research / development activities for products under development, and for post approval commitments such as regulatory agency mandated trials, or those intended to support product registration or to generate data for label inclusion remain the primary responsibility of TA development teams. Assists with the scientific review, development, approval, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities
Drives medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy. May interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc…) as they relate to on-going medical affairs projects
May act as consultant/liaison with other corporations when working under licensing agreements and/or in the evaluation of new business development opportunities
Oversees scientific/medical education of investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource. May develop scientifically accurate marketing materials, medical education programs, advisories, and symposia. Maintains an up-to-date analysis of competitor product information
Represents AbbVie at external meetings including investigator meetings, scientific association meetings, etc. May act as medical/scientific leader for several programs within an area. May represent the medical function on cross-functional integrated teams for medical affairs activities
Drives Medical Affairs strategies and is a key internal contact/subject matter expert. May lead cross functional teams in development and execution of strategic initiatives requiring integration of multiple subprojects within the therapeutic area or Medical Affairs function. Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities

Post-doctoral Pharmd Fellow Oncology Medical Affairs Resume Examples & Samples

Training and mentoring in Medical Affairs-related skill areas and exposure to related aspects in the pharmaceutical industry
Research, create, update and review medical information resources and materials to provide fair and scientifically balanced responses to medical inquiries for Seattle Genetics products
Assist with the review of investigator sponsored research proposals
Provide input in the development and review of medical publications, ensuring scientifically accurate manuscripts and materials
Coordinate and participate in the medical review of scientific and promotional materials for external publication and presentation, as well as internal training
Assist Medical Science Liaisons in supporting investigator-led studies, communicating with health care professionals, and supporting research activities
Participate in Medical Affairs-related congress planning and activities
Support other Medical Affairs activities as needed, integrating learnings and competitive insights into projects
Create and execute a longitudinal fellowship project(s) with a defined deliverable
Give regular presentations of Medical Affairs-related topics for both internal and external audiences
Work collaboratively, effectively and efficiently with all internal and external partners and stakeholders
Travel may include, but is not limited to, the annual ASCO/ ASH meetings and ASHP Midyear
A Doctor of Pharmacy (PharmD) degree from an ACPE accredited institution
Relevant Internship or Clerkship experiences
Prior clinical or industry experience is preferred
Prior oncology experience is preferred
Completion of a PGY1 or PGY2 pharmacy residency is preferred
Evidence of appropriate analytical, planning and organizational skills
Basic knowledge of the pharmaceutical industry including Product Development, Manufacturing, Regulatory, Medical Affairs, and Commercial operations
Possess good communication skills, including oral, written and presentation
Self-motivated, energetic, able to work and learn independently
Ability to thrive in a fast-paced, dynamic environment

Medical Affairs Registry Specialist / CTA Resume Examples & Samples

Coordinate and complete (within expected timeline) selected operational activities required for the registry start-up and maintenance phases for one or more registries
Liaise with the Legal department to facilitate, track, and expedite the registry contract process at sites and site contract renewals
Track contract term dates for sites to ensure site contracts are amended as needed during the life of the registries
Provide support to project leads, Associate Director and Director of MAF on vendor start-up activities
Partner with internal team to make sure communications regarding registry activities are communicated in a timely manner to ensure consistent messaging. (monthly reports)
Populate and maintain Clinical Trial Management System (CTMS) with all registry specific data
Contribute to internal team meetings to provide operational updates as they pertain to the registries as needed
May contribute to the development and review of MAF Standard Operating Procedures (SOPs) with an emphasis on the start-up and maintenance phases of registries
Provide information on registry-specific metrics and other management-reporting tools to reflect registry activities
Set up, maintenance and QC of the TMF’s
Partner with the project leads and Associate Director or above of MAF Study Management to anticipate/identify potential problems with registry activities throughout the life of the registries and develop and implement corrective actions to ensure ongoing success
Maintain tracking systems for contracts, site payments, and other tasks as identified
Initiate payment request to registry sites, CROs and other vendors at direction of the project leads and Associate Director or above of MAF
May participate in the planning and execution of investigator meetings as needed
Some experience in drug development is preferred
Experience in effectively managing multiple tasks and projects
Ability to self-motivate and work independently to meet timelines
Proficiency in various software applications such as MS Word, Excel, etc
Previous experience in biotechnology, pharmaceutical industry or other relevant industry experience. Knowledge of ICH GCPs preferred

Medical Affairs Specialist Resume Examples & Samples

To provide medical review and approval of promotional materials and activities in accordance with applicable Codes of Practice and regulations, Company policy and any other relevant regulations
Assist in development of new claims for J&J Consumer products
Partner and collaborate with internal departments as appropriate e.g. Marketing, Regulatory, Pharmacovigilance
Assist in the defence of key claims upon challenge by competitor companies and challenge on competitor advertising as appropriate
Handle internal and external medical information enquiries
Develop and provide internal product training
Maintain local WIs/SOPs
Maintain local Medical Affairs systems (e.g. Core claim database, FAQs documents, training platform)
Medical writing
Literature searching
Medical, Life Sciences or Pharmacist degree
1+ year of recent experience in a medical affairs department
1+ year of recent experience in a Consumer company

Dir, Medical Affairs Resume Examples & Samples

MD preferable with specialty training in Oncology
≥10 years total experience in oncology including hands-on Medical Affairs experience
Minimum 5 years of relevant clinical and / or regulatory experience
Knowledge of key International markets
Previous pharma / biotech industry experience
Track record in change management would be an advantage
Experience leading teams and managing people in a highly matrixed organization is required
Deep knowledge of medical affairs approaches and best practices is required
Familiarity with regulatory and legal guidelines, and best practices, regarding clinical practice and study design is required
Passionate, strategic thinker who is highly driven to be the best, and also contribute both individually and as a
Proven ability to reliably deliver, independent and self-motivated with a strong collaborative work ethic
Strong interpersonal skills and demonstrated success in achieving results through cross-functional collaborations
Good understanding of GCP, clinical trial designs, regulatory guidance, and the drivers of successful product marketing
Proven attention to detail and ability to understand, interpret and explain complex clinical data and disease states
Availability to travel approximately 40% of time

Senior Associate, Medical Affairs Resume Examples & Samples

Provide operational/workflow management and support to the US R&D organization for the DSMR process
Manage the life cycle of materials in the technology platforms leveraged by the US Medical Team
Manage vendor relationships and deliverable timelines
Monitor and track publication status with journals and vendors
Organize, manage and leading large cross-functional stakeholder meetings; guiding discussion while taking minutes and keeping the meeting on track
Assist in submitting and managing materials through a corporate risk mitigation process
Document department processes as needed
Identify and participate on process improvement teams
Ad hoc projects as requested
Familiarity and knowledge of Adobe Acrobat 9.0
Build strong relationships based on trust
Customer focused perspective with business enablement at the forefront
Strong oral and written communication as well as organizational skills with the ability to multi-task and coordinate multiple activities in parallel
Anticipate and adapt to change
Work independently yet engage in collaborative decision making
Complete tasks in a timely fashion, and function in a rapid-paced environment
Manage and prioritize multiple and varied tasks efficiently and accurately
3-5 years working in the biotech/pharmaceutical or compliance driven environment a plus
Ability to anticipate and adapt to change
Take initiative, work independently while engaging in collaborative decision making
Complete tasks in a timely fashion, and
Function in a rapid-paced environment

Medical Affairs Lead Resume Examples & Samples

Development of the local Medical Plan
Coach to the team of Medical Managers and Medical Science Liaisons (MSL) in order to develop their capabilities
Manage MSL and Medical Managers team by following the KPIs and double field visits
To be accountable for the medical plan, execution and the budget of all planned non promotional medical activities
Medical expertise and customer insights to the Brand Team
Ensure good cross functional collaboration and alignment between Medical Affairs team and other function part of the Brand Team
Development of effective interactions with Clinical Operations (both PDG and PA/GPS), including but not limited to placing studies, provide input on feasibility, sites and investigators selection

Medical Affairs Portfolio Analyst Resume Examples & Samples

Project valorization
Develop a process allowing for valorization of Medical Affairs studies
Provide sensitivity and scenario analyses on resource needs and costing to support presentation to GBU strategic meetings when studies are at the LoA (Letter of Agreement) stage
Monitoring and forecasts of studies budget
Short-term goal: Clarify and harmonize current process on study cost structure with each GBU Finances controller and current expectations from various stakeholders (GBU and CSO). Clarify AED processes and flow of approval
Review all new AED to understand the costs components and structure of each new study. Monitor studies timelines and changes in collaboration with the study planning team
Work with GBU Finance to track and review study budget needs in collaboration with the Study Teams as needed, until appropriate process in implemented
Build study cost forecast and estimate cost impact of events impacting the study conduct with information provided by the study teams
Work closely with Operations to anticipate variation of study cost compared to the forecast and communicate them to stakeholders
Work closely with OCPM in monitoring the ongoing resource allocations and gaps
Propose an interim process to consolidate all resources and costs including local costs and get endorsement from CSO and GBU finance controller/CMO Budget Process Optimization (until a common SAP system is in place)
Consolidate all resources and costs (central and local, external and internal) in collaboration with “iPOM Business Partner” who manages LoA and local commitment form
Work with Platform Controlling in optimizing the FTEs rebilling process
Contribute to the discussion on new budget model for Medical Affairs studies
Develop, get buy-in from stake holders and implement necessary processes
Business School (MBA) ideally with biology skills or engineering school with cost control skills
Minimum of 3 years similar experience in controlling (ideally in central function) or clinical project lead
Knowledge in international clinical study conduct is a plus
Highly motivated and ability to work autonomously
High communication skills to be able to interact efficiently with various stakeholder groups (Clinical operations, Finance, Procurement, GBUs, CMO Budget Process Optimization)
Responsiveness and ability to deliver within short timelines
Expert in computer systems (Excel, PowerPoint, Access, planning and reporting tools)

New Products Lead, Medical Affairs Diabetes Resume Examples & Samples

At least 5 years of experience in the Pharma business
Knowledge of clinical medicine and basic science in Diabetes
Past experience in the US clinical setting and understanding of US healthcare care system
Knowledge of the key experts in cardio-metabolism field

Director of Medical Affairs Resume Examples & Samples

Develop Medical strategy including path to reimbursement for existent and future products
Contribute to strategic planning and execution of the studies of multi-biomarker blood tests (changed sequence of this bullet point)
Initiate and conduct collaborative research projects with external investigators related to clinical utility of multi-biomarker blood tests in Rheumatology
Develop and manage interactions with investigators of collaborative studies
Contribute to the design, implementation and execution of retrospective and prospective studies of multi-biomarker blood tests
Work with investigators interested in developing and performing studies with the company’s commercially available assays in Rheumatology and Immunology
Identify and analyze relevant internal and external datasets, generate and interpret data and prepare presentations of study results
Work with the biostatistics team to develop statistical analysis plans of internal and collaborative studies
Drive timely generation, publication and presentation of clinical results as study reports, abstracts or manuscripts
Collaborate with KOLs, community rheumatologists and pharmaceutical partners
Contribute to new product development
Working closely with Crescendo’s Managed Care and Medical departments, provide guidance on the managed care market/payer landscape with the ability to build relationships with key payer groups and effectively present information
Provide scientific support at international and regional Medical Congresses

Vaccines Medical Affairs Lead Resume Examples & Samples

Minimum of (3) years’ experience in pharma or biotech industry
Demonstrated strong interpersonal and communication skills
Demonstrated initiative, leadership, and consistent strong performance
Scientific, Analytical, & Business acumen
Account team planning expertise with a broad set of ecosystem customers
Up to 50% Overnight Travel depending on location of residence

Manager, HIV Medical Affairs Resume Examples & Samples

Create/update Topical Slide Decks, Standard Response Documents (SRDs), and Answers to Key Questions (AKQs) for HIV Medical Affairs (MA) and ensure these documents are aligned with the current Plan of Action and needs of the field teams and other end users
Write abstracts, manuscripts, and advisory program executive summaries; create presentation slides for medical conference, advisory programs, and personnel training's as delegated by the Director
Works collaboratively with Medical Information to create responses to medical inquiries
Work collaboratively with Gilead personnel across multiple functional areas, including Medical Science, Medical Information, Commercial, Marketing, Clinical Research, Drug Safety, Regulatory, Public Affairs, Government Affairs and Legal
Knowledge and appreciation of all applicable regulatory and legal requirements for Medical Affairs activities is essential, as is accountability for serving as a role model for others in line with Gilead’s Core Values
Advanced degree (i.e. MD, DO, PhD, NP/PA) required with ≥2 years of relevant clinical practice experience in PrEP and/or HIV. Experience in pharmaceutical industry is preferred but not required
Experience in evaluating conference presentations and publications, developing posters and slides for conferences, and medical writing
Excellent analytical and verbal/written communication skills; demonstrated ability to understand and translate complex scientific/clinical data

Director, Scientific Medical Affairs Resume Examples & Samples

Establishes and approves scientific methods for hypotheses, rational, design of affiliate protocols and their reports
Responsible for understanding the regulatory requirements related to the clinical studies and accountable for complying with those requirements. Serves as the scientific team interface for key regulatory discussions
Initiate research projects and drive them to completion, resulting in high quality publications

UK Head of Medical Affairs Oncology Resume Examples & Samples

Building and leading the UK Oncology Medical Affairs department including defining critical strategies and executing medical affairs activities that support the therapy area
Key role within the Oncology Brand Team including integrateing the Medical Strategic plan into the Brand Plan
Partnering widely across the business to ensure compliance, scientific /clinical input, therapy area training and other support is given proactively
Establish and develop strong relationships with key external customers including External Experts, Public Bodies and key external influencers
Develop and control consolidated budgets for Medical activities for the Oncology Medical Affairs team
Supervise the initiation, conduct and analysis of the results of clinical /scientific programs and clinical education activities; drive the integration of these results in the brand strategy
Supervise and performance manage team and ensure Medical Science Liaisons are appropriately aligned to the core medical and brand strategies
Maintain AbbVie Ltd as registered site for Higher Medical Training and ensure appropriate HMT and CME training requirements met for all physicians within the Medical Affairs Department, for example, support re-validation for doctors with Faculty of Pharmaceutical Medicine
Qualification as either a Medic, PhD or Pharmacist
Previous proven Medical Affairs experience including copy approval, running IIS/IITs, named patient responses, ad boards, symposia, KOL development activities, etc
Experience of working with Brand teams and inputtng into Brand Plans
Experience of working in a complex matrix organisation
Experience of line management

Senior Medical Affairs Specialist Resume Examples & Samples

5+ years of professional experience or Master’s or Doctoral degree and 2+ years of professional experience
Experience writing technical reports on complex medical data/information
Bachelor's degree in a biologic science with preference towards healthcare or medical profession (e.g., nursing, medicine, epidemiology, pharmacology, biological science or other related medical/scientific field)
Masters or PhD in Life Sciences, or Pharmacology, or related disciplines
Industry Experience in a Life Science Companies, in Safety, Medical Affairs, Drug Information, Clinical Research, Clinical Quality, Regulatory, Medical Science Liaison, or related discipline
Competency interpreting published medical evidence to provide perspective, in particular when there is conflicting data and controversy
Solid medical and/or scientific background with the ability to understand complex disease states and different treatment modalities and as it relates to clinical studies
Demonstrated ability to clearly and effectively communicate verbally and in writing and interact and influence healthcare providers and field personnel
Ability to identify, compile, analyze, summarize and educate on complex medical/scientific data from multiple sources
Solid knowledge of industry standards as well as all applicable laws and regulations
Developed project management skills, including ability to balance risk, effectively influence diverse team members, and ownership of responsibility for outcomes
Solid critical thinking and problem solving skills
Proficient computer skills with experience in Microsoft Office Word, PowerPoint, and Excel
Collaborative spirit
Ability to work in matrixed organization
Expertise in clinical study design, evidence level, and interpretation
Knowledge and competency interpreting published medical evidence to provide perspective, in particular when there is conflicting data and controversy
Demonstrated ability to make timely and well-reasoned decisions based on an insightful analysis of all critical information; ability to balance analysis with decisiveness
Demonstrated ability to cultivate relationships with co-workers in a cross-functional environment
Work experience in neurological diseases, pain management, and infusion technology
Experience writing medical publications
Medical device or pharmaceutical industry experience
Epidemiology/statistics education and application
While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, telephone, and communicate with peers and co-workers
Travel up to 10%

Head Medical Affairs, Mitg-meacat Resume Examples & Samples

1- LEADERSHIP MITG MEACAT MEDICAL AFFAIRS TEAM
Medical/scientific background (MD, PharmD, or PhD with ideally 5 – 10 years experience
In the Pharmaceutical or Medical Device Industry)

Senior Medical Affairs Specialist Resume Examples & Samples

Minimum of Bachelor’s Degree and/or Master’s Degree / MD, PhD degree preferred
2+ years of experience in the medical device or pharmaceutical industry if MD/PhD degreed
6+ years of experience in medical device or pharmaceutical industry if BS/MS/MBA with focused medical device sales training/marketing and/or clinical education
Intermediate or advanced knowledge of MS Word, Excel, PowerPoint, Access and internet search engines
Proven understanding of the medical device or pharmaceutical arena and healthcare system requirements
Analytical skills and capability to understand, interpret, and communicate complex scientific information
Insight to determine sales and customer communication/education needs during product life cycle
Ability to work independently and effectively on cross-functional teams
Results and solution oriented
Demonstrated ability to make timely and well-reasoned decisions and adapt to shifting priorities and competing demands

Medical Affairs Coop Resume Examples & Samples

Helping to respond to unsolicited medical information requests from healthcare professionals
Retrieve, analyze and interpret the scientific literature to assist in providing medical information to health care professionals related to Alkermes’ marketed products
Assist in the development, updates or revision of medical information standard or customized responses
Understand the various roles, processes and industry standards involved in providing medical information and review in the pharmaceutical industry setting
GPA of 3.0 or above
Interest in the practice of Medical Information in the pharmaceutical industry setting

VP, Medical Affairs, Oncology & Urology Resume Examples & Samples

Provide strategy and leadership for Medical activities supporting the adoption and reimbursement of Genomic Health, Inc. products serving our oncology and Urology communities in the United States
Manage and develop the team of Medical Directors and Genomic Science Liaison team to support investigator sponsored trials and educational activities supporting Genomic Health products. Direct management responsibilities, including but not limited to, goal setting, performance and compensation review, mentoring and development
Oversee the US-based Medical Affairs investigator-initiated Oncology and Urology study program
Provide leadership in working with Medical Development and Marketing/Sales on setting up and supporting Advisory Boards, Speaker Training and External Payer Reviews as needed
Function as a vital medical resource internally to Genomic Health, company-wide
Function as an important outreach person representing Genomic Health to National associations to include ASCO, American Society of Clinical Oncology and AUA, American Urology Association
Works closely with key opinion leaders regarding Genomic Health scientific and medical presentations and communications
Work with key departments (Research and Development, Oncological Sciences, Sales, Marketing, Managed Care, Quadax etc.) in developing and implementing appropriate strategy, budgeting and training as needed
Take complex medical messages and enable clear and concise understanding by personnel within and outside of Genomic Health
Deliver lectures as required before health care providers and internal commercial teams that inspire actions for implementing aligned strategies and activities
Review and Ensure marketing tools for medical accuracy and completeness
Stay abreast of new developments, papers and trends in Oncology and Urology that impact or influence our product portfolio
Travel requirements range from 30 – 50% in order to meet with key physicians, lead field medical teams and meet with key researchers and payers
MD degree required; oncology and Urology specialty training preferred
Strong clinical/medical background (training and/or experience) with ability to successfully communicate and teach in a complex and competitive environment. Minimum of 15 years of combined experience required in hospital, practice or industry settings
More than 10 years of experience in a Medical Affairs organization preferred; will consider highly qualified candidates with less experience. Prefer experience in pharmaceutical, biotech or medical device industry
Proven leadership and management abilities, including demonstrated ability to attract, develop, motivate and lead a group of highly educated individuals in cooperative efforts toward common goals
Strong communicator with ability to maintain open communication with internal employees, managers and customers as needed in both written and oral formats
Public speaking ability required
Strong analytical skills and familiarity with medical messaging necessary
Demonstrated team player with ability to integrate and apply feedback in a professional manner
Able to prioritize and drive to results with a high emphasis on quality
Specific experience in molecular diagnostics in oncology

Assoc Dir, Oncology Medical Affairs Resume Examples & Samples

Medical degree, Oncology preferred
Minimum 2-3 years clinical experience and >5 years pharmaceutical industry experience in Medical Affairs, Medical-marketing or Industry Code of Conduct
Pharmaceutical industry and healthcare environment, especially in Oncology
Knowledge in industry Code of Conduct
Experience in Sales and marketing, Finance, Corporate / Head office environment
Good Local Compliance/Regulatory understanding
Leadership: Proactively identify projects and opportunities; and proven ability to lead and develop people in an organization
Cross Functional Team Leadership: Establish, facilitate and drive towards reaching objectives
General business analytical skills: understand, analyze, evaluate and interpret financial statements
Good Negotiation, problem solving and decision making
Good Conceptual and Strategic thinking
Facilitation: cross functional teams often consisting of senior team members
Good Presentation Skills
Good Planning/Organizing and Analysis and Evaluation skills
Investigative Skills
Excellent Communication Written/Oral
High level of interpersonal skills
Ability to manage variety of tasks under pressure
Project management skill and experience
Commercial Acumen and time management
Computer Skills – Excel, Word, PowerPoint, Internet, Database searching

Regional Director of Medical Affairs Resume Examples & Samples

7+ years pharmaceutical or related industry experience in country with proven track record of contribution to commercial, medical and/or clinical development strategies in country
Customer expertise especially scientific leadership and other key stakeholders (public groups, government officials, medical professional organizations) in oncology and/or hematology
Proven ability to effectively communicate information at management level, with public groups and to scientific leaders

Medical Affairs Lead Resume Examples & Samples

Understand and follow up of different country situation / harmonize inputs from countries
Prepare CE Medical affairs plan and SLs engagement plan
Propose and/or support the development of regional projects (LCEs, Patient Support Programs) and facilitate the approval process
Evaluate the potential of local activities for best practice sharing
Support training and onboarding of local team members
Representing the cluster on regional level
Attract clinical research (GCTO) into the region
Work in close cooperation and provide scientific support and input to the CE Regional Brand team
With the CE Brand Lead, propose and prepare CE medical strategy to be adapted to country specific needs
Planning and implementation of regional CME events, CE Advisory Boards, Local Advisory Boards, promotional campaings provising specific CE adapted materials
Preferred proficient understanding of the drug development process, relevant diseases and therapies, and the local medical practice
Demonstrating strongly ethics and integrity
Excellent interpersonal skills related to management of scientific leaders and authorities
Collaborative problem solving approach within the team Excellent presentation skills
Strong leadership behaviours within delivering value for customers including patients by understanding and meeting their needs; act with candor and courage; make rapid, disciplined decisions
Strong stewardship skills
Ability to work effectively in a matrix organization and act as “influencer” in relation to local MAMs/MAs
Excellent understanding of core systems, tools, and metrics
The position requires either a Medical Degree (preferred) or a PhD/PharmaD in life science
Relevant prior experience can replace the above mentioned degree requirements

Nordic Oncology Medical Affairs Indication Lead Resume Examples & Samples

Maintain solid scientific and medical expertise and be recognized as the scientific lead for the assigned indication(s)
Coordinate Clinical Scientific Leader (CSL) engagement plan across the Nordics and organizing regional events such as Nordic advisory boards with the Medical advisors/MSLs in other countries
Execute the CSL engagement plan within the country of origin for the applicable indication(s) and be the main medical strategic partner to internal and external stakeholders and support efforts in strategic areas such as regulatory bodies, payers groups and decision makers
Identify medical and scientific gaps, and prioritize tactics to fulfill CSL needs
Responsible for the development, prioritization and delivery of strategic and tactical plans that addresses identified gaps
Responsibility for the Oncology Medical Affairs Plan for the assigned indication, including annual budget preparation
Lead a team of Medical Advisors/MSLs within the given indication(s) and ensure staff results by communicating expectations – planning, monitoring, and appraising results, in addition to fostering teamwork, training employees and develop personal growth opportunities
Work in collaboration with EUCAN Medical Affairs teams and Regional Director of Medical Affairs to advocate for support of Nordic initiatives at the regional/global level
An active member of key strategic cross-functional teams, providing scientific expertise and ensuring scientific credibility and high ethical standards throughout all activities
Support to the Oncology Business Unit and Market Access Group to ensure the successful management of existing products and launches of new products
MD (Or equivalent, e.g. MB.Ch.B., Bachelor of Medicine), Pharm D, Pharmacist or PhD in life sciences
Possess 3-5 years of pharma-industry experience with excellent interpersonal skills related to management of scientific leaders and key opinion leaders
Preference to candidates with earlier experience as Medical Advisor and/or other relevant Industry experience within the oncology, hematology or immunology field
Preference to candidates with demonstrated leadership skills with ability to create and work in high performance teams, and to work in a matrix organization. Team leading capability and excellent team player; must excel at teamwork in cross-functional groups, including business teams, across several therapeutic areas
Good understanding of the oncology area as well as of the business, market access and political environment
Strong working knowledge of all applicable local regulations and global development policies, procedures and processes
Excellent interpersonal skills, as well as listening and coaching ability
Masters and embraces cross-functional matrix collaboration with strong leadership behaviors within delivering value for customers, including patients, by understanding and meeting their needs; act with candor and courage; make rapid, disciplined decisions
Excellent oral and written communication skills in English & his/her native language. Advanced presentation and facilitation skills

Analyst, Medical Affairs Resume Examples & Samples

Review and thoroughly understand evidence generation projects, and the steps involved in completion of each
Organize and plan tasks necessary for completion of evidence generation projects
Work collaboratively at customer sites to complete on-site observations, and data collection as required
Provide clear accurate analysis and written reports associated with each project
Providing presentations related to evidence generation projects as assigned
Interaction with clinical development teams to as needed to accomplish the evidence generation priorities
Complete other projects related to clinical trial protocols and other related tasks as assigned
This position involves travel to customer locations
Demonstrates thorough knowledge of healthcare supplies and/or pharmaceutical products, including utilization and related services
Processes, researches, analyzes and interprets healthcare data across multiple disciplines
Makes recommendations regarding healthcare data utilization
Utilizes technology and makes recommendations regarding application and utilization of data on a broad scope
Makes recommendations regarding processes and methodologies to drive improved financial, quality and patient care results
Degree in a health sciences, economics or related discipline. Relevant disciplines may include Medicine, Pharmacy, Health Services Research, Economics, Epidemiology, Public Health and Healthcare Policy
Min 3-5 years’ experience in acute care and or health system environment
Understanding of evidence generation work concepts, principles and practices
Research and analysis skills required including; literature reviews, secondary data analysis methods, writing and excel spreadsheet models
Superior communication, interpersonal, and organizational/administrative skills
Ability to collaborate and work well in a cross-functional, multi-cultural environment
Proficiency in project management
Able to collaborate with project teams in multiple technical areas (programming, modeling, literature analysis, etc.)
LI-AS1

Associate VP, Medical Affairs Field Medical Resume Examples & Samples

Extensive experience and proven competency in developing and leading a large and complex US field based medical affairs organization across both the health system and, ideally multiple therapeutic areas as well
10+ years pharmaceutical (or related) industry experience
Deep knowledge of the changing US healthcare environment
Track record of developing excellent personnel and teams
Excellent interpersonal and communication (written and oral), analytical, and results oriented project management skills
Scientific/Clinical acumen
Business and financial acumen required
Possess a thorough understanding of all US compliance guidelines relevant to the pharmaceutical industry and field medical roles
Highly ethical and with strong compliance record
Ability to manage others through change, demonstrating poise under pressure and motivational leadership
Travel = 30%

Product Development Medical Affairs Quality Leader Resume Examples & Samples

Implement Quality Management processes to improve accuracy or timelines and/or to meet established standards (e.g. compliance checks)
Develop and maintain PDMA quality standards and metrics for key medical affairs activities
Review audit reports, propose and monitor corrective and preventative action plans (CAPAs) to improve medical affairs standards and processes
Act as a active member of cross-departmental Quality improvement workstreams
Support inspection readiness for PDMA
Provide compliance support by answering questions or providing advice on ICH, GCP, Standard Operating Procedures (SOPs), regulations and guidelines and bring issues to the attention of PDMA Leadership Team members as appropriate
Provide ongoing compliance advice and support to PDMA, regions and affiliates in alignment with SOPs and regulations

Director of Medical Affairs Resume Examples & Samples

Develop professional relationships and communicate with national /regional thought leaders in the areas of clinical science, pharmacy outcomes and quality management support sales and marketing teams for consultative and Advisory Board functions
Participate in the development and review educational programs for regional and national symposia to promote and maintain knowledge of the regulatory, clinical and business aspects of 503b compounding space
Function as a liaison to support health care professionals, professional organizations, and medication safety advocacy groups that share the mission and vision of PharMEDium
Review requests for unrestricted educational grants to ensure appropriate use of resources
Provide scientific input and expertise in the design and construction of promotional materials and events. Present relevant scientific information at marketing functions when necessary
Develop framework for and implement outcomes studies that will demonstrate the impact of the PharMEDium portfolio
Review specific adverse event reports and aggregate adverse event statistics where patients experienced a lack of effect or possible significant adverse outcome
Develop a business plan and timeline for the creation and oversight of a team of Medical Liaisons to serve as field based clinical and business specialists
Attend scientific and professional meetings and support development of post-meeting deliverables
Graduate of an Accreditation Council for Pharmacy Education (ACPE)-accredited College of Pharmacy with pharmacy licensure in good standing
Completion of ASHP-accredited PGY-1 Residency Program, required
Board Certification in a clinical specialty recognized by the Board of Pharmaceutical Specialties
Minimum of 7 years clinical experience in health-system pharmacy
Well-developed interpersonal and verbal and written communication skills
Experience in medical writing and presentation of scientific/technical information
Solid teamwork and collaboration / negotiation skills

VP, Medical Affairs Resume Examples & Samples

Must possess and maintain a current California medical license and board certification in area of specialization
M.D. or DO degree, with a minimum of seven (7) years of broad experience in clinical practice
Experience as a hospital medical director of a specialty department and leadership roles in hospital medical staff
Knowledge of industry trends affecting health care
Must have a record of demonstrating leadership competencies and management style that exemplify the Dignity Health Values and Mercy’s Standard of Performance
MBA or credential in medical management, or education in the area of healthcare administration or a related field
Strong knowledge of CMA, JCAHO, and State rules and regulations, as well as quality control and performance improvement principles
Leadership experience particularly as chief of Staff and/or Medical Director at an acute health care facility and/or regional healthcare system
Substantial knowledge of medical practice, managerial and leadership competencies and skills
Substantial knowledge of medical staff roles and responsibilities and leadership principles at the senior level

Oncology Medical Affairs Lead Resume Examples & Samples

Leads the development of the medical strategy and drives the strategic and tactical execution of MSD oncology, immune-oncology and oncology supportive care products. Development and execution of the strategy is done in close collaboration with the Oncology Business Unit Head and the Local Market Access Lead and with other local and regional stakeholders
Inspires, challenges and provides direction, prioritizes activities & resources priorities with the guidance of the MER Medical Affairs Director Oncology, sets objectives and monitors performance against objectives of the oncology medical affairs team in pursuit of the OGMA mission within Greece
Acts as a role model in the field when it pertains to building solid and meaningful/purposeful customer relationships with Key Opinion Leaders and other relevant local Health Care Community members; seek input & transfer knowledge about MSD products and their utilization in the Greece and drives (internal & external) decision making and progress of projects that improve the lives of people with cancer

Assoc Dir, Medical Affairs Resume Examples & Samples

Per medical strategy, establish and/or enhance partnerships with key academic institutions and develop relationships with key thought leaders
Per medical strategy, establish appropriate partnerships with KOLs in areas of scientific interest
2-3 years of experience in biopharmaceutical medicine, preferably within a matrix or franchise structure
Experience leading project teams at the brand or disease area levels in country, regional or global organizations is preferred

Clinical Trial Liaison, Medical Affairs Resume Examples & Samples

Provide accrual enhancement activities at trial sites or referral centers
Exchange complex medical & scientific information
Facilitate investigator interactions with Medical Directors
Provide internal teams with feedback and insights from interactions and discussions
Provide support at professional meetings, collect competitive intelligence and develop tools that support the function
Self-Education and Training
PharmD, PhD or RN with advanced degree preferred
3+ years of oncology experience and experience as field-based employee
Think strategically and execute passionately
Ability to effectively build relationships and work with global medical thought leaders
Ability to summarize complex information and present in a clear, concise, and scientifically accurate manner
Strong problem solving, decision-making, influencing, and negotiation skills

Medical Affairs Operational Specialist Resume Examples & Samples

Coordination of activities between Investigator, Local and Global Medical Teams through the lifecycle of the IIS including receipt, review, approval and release of IIS submissions to the end of the study lifecycle and the management of all related documentation
Bachelors degree or other equivalent post-secondary education degree
Demonstrated experience in conducting clinical trials of investigational and marketed therapeutic agents or equivalent
Knowledge and experience in legal/contractual activities and budgeting for clinical studies
Ability to work independently as well as in a matrix and cross-functional team environment while fostering a customer-centric culture
Excellent communication, negotiation, and organizational skills
Proven time/project management skills combined with excellent interpersonal skills
Working knowledge of TPD, FDA and ICH regulations governing conduct of clinical trials
Advanced knowledge of PC software, including MS Word, MS Excel and MS Power Point
Strong business acumen with the ability to multitask across various studies
Ability to maintain a high degree of confidentiality and attention to detail

Head Medical Affairs Immunology Resume Examples & Samples

At least 7 years pharmaceutical industry experience
Experience in the design/implementation of medical affairs studies
Strong background in immunology and biologics
Experience in rheumatology, or dermatology and gastroenterology (with experience in immune-mediated diseases within these TAs)
Historic clinical practice in relevant therapeutic area(s) preferred
Effectively present scientific and medical information before large and small audiences
Translate complex scientific/medical concepts to audiences with differing scientific and technical knowledge
Practical knowledge of Good Clinical Practices and regulatory requirements

Medical Affairs Operations Manager Resume Examples & Samples

Supports the medical affairs team in responses to solicited and unsolicited requests for on- and off-label use of TEG products
Manages the release and tracking of technical materials used by the field medical force to ensure compliance with internal SOPs, US FDA Code of Federal Regulations and related governmental guidance documents
Carries out duties related to the regulatory and legal aspects of distributing scientific publications such as seeking copyright permissions or licenses
Follows the Haemonetics internal guidelines and FDA guidance for industry for distributing scientific and medical information and helps draft applicable SOPs
Supports the preparation of metrics and status reports and performs QC related to IIT management, specifically patient enrollment as well as cartridge supply, device placement, cost, milestones and payments tracking
Assists in the creation and development of applicable research papers and editorials, facilitates delivery of the publication plan

Spclst, Medical Affairs Resume Examples & Samples

Engage in discussions regarding scientific and clinical evidence surrounding new and existing MSD products and claims
Provide relevant scientific background information for formulary decisions, treatment guidelines and Public Health programs
Provide fair balanced, objective, scientific information and education to health care providers, formulary committees, basic scientists and to internal business partners as required by identified business needs
Have no sales objectives or accountability for prescribing or sales of any MSD product and do not participate in Sales Incentive Plans (SIP)
Discussions between MSLs and Health Care Professionals should focus on bi-directional exchange of ideas on disease related topics, scientific presentations of data in the public domain, and reporting scientific results (e.g. discussion of clinical study results.)
Product claims must be discussed in the context of clinical and scientific exchange, and shall be consistent with prescribing information and substantiated with reference-able data
If unsolicited, responses to requests that necessitate providing information or data that is not within the current product indication, must clearly disclose that the information being provided is not contained within the regulatory-approved labeling and that MSD recommends the use of its products in accordance with its approved labeling
In response to an unsolicited request for information, the MSL can provide references, abstracts and bibliographies for the specified topics. The literature and data that MSL use to support their discussions, as a general rule, are peer-reviewed, of the highest quality, and from databases and sites of information approved by the Medical Affairs Management Team
MSLs must not provide materials to Sales Representatives as these should only use materials approved in compliance with the Local Review Guidelines

Senior Medical Affairs Associate Resume Examples & Samples

Ability to source and collate scientific data from literature searches, registries and other relevant sources to produce material for internal and external use
Ability to work with commercial account teams to translate existing scientific data into key brand messages or to support key brand messages outlined in the brand plan
Ability to conduct ad hoc research on specific treatment topics that the commercial team requires or where there is interest from prescribers
Ability to utilise internal Janssen global network to improve early visibility of global clinical trials and incorporate into local material
Ability to work with MSLs and Medical Advisors to support the generation of data, abstracts and other publishable information

Temp Medical Affairs Associate Resume Examples & Samples

University graduate degree or above in pharmacy
Registered pharmacist
At least 2-4 years of Clinical Research Associate (CRA) or project management experience or related equivalence
Clinical study execution related knowledge, like GCP, IRB application, etc
Good knowledge of medical science
Good project management skills and sense of urgency
Good communication and coordination skills
High degree capability of initiative and planning
Ability to understand and integrate complex scientific concepts
Versatility and learning appetite
Familiar with PC operation, Microsoft Offices application

Head, Medical Affairs, India Resume Examples & Samples

Medical degree with post-graduate qualification in Medicine, Pharmacology or other relevant specialization
Extensive pharmaceutical industry experience
Therapy area oversight
Understanding of all regulations related to promotional practices
Team Leadership: a track record of effectively leading substantial, performance-focused teams, be able to relate to all levels of the organization and stay constantly in touch with relevant developments; be experienced with building on existing excellence and attracting talent to projects
Demonstrated experience as a strong integrative matrix leader that is able to bring together the various strands of input from R&D, Commercial and Medical into a cohesive strategy and plan that brings benefits to patients, other stakeholders, and to the GSK business
Prior experience across multiple therapy areas
Interact with Key External Experts at congresses, symposia, CME programs and launch meetings to develop a collaborative relationship and leverage their expertise to formulate/drive brand strategy
Ensure prompt and substantiated medical information responses to medical queries
Ensure appropriate review and approval of promotional materials in compliance with GSK policies and local regulations
Participate in Medical Governance Committee meetings
Evaluate new product opportunities and provide feedback to business development team based on current medical evidence
Ensure timely updates of prescribing information and abbreviated prescribing information

Head, Scientific & Medical Affairs Oncology Resume Examples & Samples

Physician (M.D. or equivalent) with completion of related medical residency/fellowship program
Must demonstrate excellent communications and leadership skills
Enable and drive change – ability to influence/lead to deliver results. Must have direct leadership (line management) experience
Flexible thinking – ability to analyze external environment and translate to strategy. Must demonstrate good judgment
Responsible for the recruitment, development and performance management of scientific and medical affairs team members ensuring highest level of scientific and medical expertise
Develop effective team communication, analysis and documentation of performance of scientific affairs activities and knowledge through the application of appropriate governance, reporting systems and structures
Develop and execute the Oncology R&D Scientific & Medical Affairs strategy in support of the Corporate, R&D and commercial strategy
Identify, establish and maintain collaborative relationships with key investigators, institutions, and cooperative groups
Lead and facilitate advisory boards and key thought leader activities
Facilitate and/or deliver scientific/medical information, or clinical and research findings of products through symposia, lectures and publications
Represent organization at medical meetings, advisory boards, outreach meetings
Provide scientific and medical input for agency interactions and oncology-related agency workshops
Interface with patient advocacy groups and lead patient engagement activities
In partnership with tumor matrix team, accountable for maintaining deep product and disease area expertise and a deep understanding of patient and physician interactions and clinical decision making and impact

Medical Affairs Resume Examples & Samples

Physician (M.D. or equivalent) with board certification. Current Medical license or eligibility for US Medical licensure (or equivalent outside of the US) is required. Board certified Pulmonologist
Demonstrated ability to lead effective engagements with the key medical/scientific experts
Medical Affairs or Clinical Development experience is desirable
Effective team and matrix working, with proven ability to motivate, influence, negotiate, and collaborate; strong project management skills; solid planning and organizational skills
Strong strategic, scientific/analytical problem solving skills
Strong business acumen and communication skills (oral and written), including the ability to identify and articulate the value of clinical and heath outcome data to internal stakeholders and external customers
Robust knowledge of the US healthcare environment including disease-specific research priorities, public health need, competitor landscape, decision making practices of Managed Care Organizations, clinical practice trends and treatment guidelines evolution
Teaching skills. The candidate is expected to be the educator-in-chief on his/her disease area within the USMA group
High quality presentation skills – a master teacher
Excellent communications and leadership skills
Building collaborative relationships – ability to work effectively with others, delegate appropriately and foster a culture of collaboration
Flexible thinking – ability to analyze the external environment and translate to strategy and gain support of others to implement a vision. Must demonstrate good judgment
Developing people – ability to develop influencing/leadership skills in others, act as teacher, coach and mentor toward others

Head of Medical Affairs Rare Diseases Resume Examples & Samples

MD (and PhD preferred) with considerable experience within R&D, (HQ and local/regional) Medical Affairs and strong business acumen
Experience in Rare Diseases and in interactions with relevant external stakeholders (patient groups, regulators, HCPs, etc.) in Rare Diseases strongly preferred
Demonstrated solid understanding and knowledge of late stage drug development, specialty care prelaunch/launches, core principles in how to use clinical data, guide strategic use of clinical data, and implement clinical studies. Furthermore, experienced in budgeting and forecasting
Proven experience of interactions with high level external experts (physicians) across multidisciplinary therapeutic areas - requiring a high level of medical knowledge/experience, understanding of patient management, and strong clinical judgement on benefit: risk significance
Develops Rare Disease medical affairs strategy and provides medical strategic leadership in pre-launch, launch, and life cycle management activities
Owns the medical affairs accountability for the full portfolio and tracks medical affairs metrics and performance for the Rare Disease Business Unit
Oversees medical affairs governance and works across the entire Rare Disease Business Unit, including connections with Regional Medical Leaders
Provides medical insights, integrated evidence strategy & plans, and medical stakeholder communications
Represents the medical voice of Rare Disease Franchise into R&D
Reviews and approves the asset evidence plans
Coordinates Rare Disease Global Medical Asset Leads + RDU Area Medical Leaders, RDU Patient Advocacy, and Medical Strategy & Operations
The ability to influence both externally and inside the company: able to build and maintain effective relationships with a wide range of international and diverse stakeholders; talented in managing both internal and external relationships and working effectively in matrix structures across functions and geographies, building consensus even in tight situations; possess a natural inclination for teamwork and an ability to constructively contribute to discussions beyond one’s strict scope of responsibility
Can think strategically and identify key priorities: aware of the overall medical issues facing the business in a broad range of topics, markets and cultures; using superior analytical skills and an ability to develop proactive plans to address opportunities or overcome challenges; be capable of spotting previously unidentified medical and business opportunities and contributing to shaping the company’s strategy beyond own functional area
Track record of driving results: able to instil a sense of pace and urgency into the business; be a self-starter and a self-motivated individual who moves quickly and decisively in all circumstances; be able to track performance against measurable metrics with strict observance for quality and compliance; possess a strong inclination towards continuous improvement and questioning status quo; be able to always keep the company’s performance in focus
Team Leadership: as indicated by a track record of effectively leading substantial, performance-focused teams, and being collectively accountable for meeting agreed objectives without necessarily having direct hierarchical responsibility over them; be able to relate to all levels of the organization and stay constantly in touch with relevant developments; be able to manage by influence rather than authority; be experienced with building on existing excellence and attracting talent to projects wherever and whenever needed

Medical Affairs Medical Director Resume Examples & Samples

Physician (M.D. or equivalent) with board certification in Internal Medicine with significant interest in pulmonary medicine. Subspecialty certification in adult Allergy/Immunology or Pulmonary Medicine is preferred
Pharmaceutical industry and medical affairs experience is preferred
Clinical practice experience is required
Must be able to demonstrate excellent medical communication skills
Must be able to clearly demonstrate a thorough understanding of the US healthcare environment including all external stakeholders
Must be able to demonstrate understanding of medical affairs accountabilities for evidence generation, external engagement and internal advice; direct experience preferred
Must demonstrate disease area expertise and appropriate medical and/or clinical experience
Continuous improvement – ability to drive a performance based culture
Customer driven – ability to understand patient needs and institutional concerns
Subspecialty certification in adult Allergy/Immunology or Pulmonary Medicine is preferred. Pharmaceutical industry and medical affairs experience is preferred
May include accountability of other medical staff for execution of work and people development for one or more medicine(s)

Oncology Medical Affairs Team Lead Eastern U.S Resume Examples & Samples

A minimum of 7 years of field-based medical affairs experience
A minimum of 4 years of oncology medical affairs experience (field or headquarters based)
Demonstrated ability to effectively lead and coach scientific / medical colleagues at all skill and knowledge levels
Excellent interpersonal communication and presentation skills, strong personal integrity, teamwork abilities (including the ability to lead a oncology team across a geographical area), business acumen, and focus on scientific education and dialogue

Assistant, Medical Affairs Resume Examples & Samples

A High School Diploma or equivalent is required as well as 2 years’ related experience required
Strong computer skills, including proficiency in MS Office Suite
Broad knowledge and understanding of Edwards policies, procedures, and administrative requirements
Strong communication and interpersonal relationship skills

VP Medical Affairs Therapeutics Resume Examples & Samples

The Vice President Medical Affairs Therapeutics provides expert medical strategy and leadership to the Medical Affairs Therapeutics Unit, and I&D overall, in order to build and sustain a pipeline of products and claims that will enable Consumer Health to defend and grow its leadership position
The Medical Affairs Therapeutics Department will have specialists in the various therapeutic areas and it will be the job holder’s mandate to ensure that these team members are supported, mentored and developed in order to build a capability in Consumer Health that is second to none in the Industry
The Incumbent will be the primary interface with the Medical Affairs and Clinical Development functions in the Bayer Pharma Division representing Consumer Health matters and will report functionally to the Chief Medical Officer of Bayer AG. She/ He will interface with the Unit Head and the Technical Category Leads to determine the appropriate Medical strategy for new product development, entry into new markets or to extend the current product and claims portfolios
This position will liaise with the Pharma/Consumer Health Medical Affairs platform Function to ensure that appropriate Medical Affairs support at the country level is provided for new and currently marketed Therapeutics products around the world
This position will assess competitor portfolios and claims and make recommendations for product expansion opportunities as part of any due diligence activities. The job holder maintains a comprehensive understanding of the current and emerging medicine and science related to all of the therapeutic areas of the Unit
She/he develop a long term medical/scientific strategy which maximizes each product and identifies areas for clinical input in the form of generating new data and/or other support for products and claims that drive business growth
The incumbent will establish strong relationships with KOLs, be seen as a key partner between the business and the Medical community and serve as external spokesperson and liaison for the Therapeutics Unit
Medical Doctorate required
At least 12+ years industry experience (pharmaceutical and/or OTC) in clinical development or medical affairs
Strong focus in clinical development and medical affairs, with global experience preferred
Ability to be the company spokesperson on global clinical or medical issues
Demonstrated ability to formulate medical / clinical strategies and actionable medical insights
Ability to speak persuasively, clearly and with conviction to press and regulatory authorities
Proven ability to think strategically across geographic boundaries and to understand the broader business goals and the specific clinical development needs of the countries
Considers the future implications of plans and weighs the benefits and risks of actions
Strong influencing skills are required to effectively impact decision making within CH and external partners
Business acumen and understanding of the global commercial environment
Proven track record in successfully managing major issues, especially as they relate to the Clinical Development programs in the Consumer Health or similar industry sector
Proven leadership abilities and a successful track record of directing clinical development teams
Established reputation for being a highly effective communicator, with strong oral and written communications skills

Head of Medical Affairs Resume Examples & Samples

Lead & oversee all MA activities for the entire Core Imaging marketed portfolio in the United States and Canada (USCAN) region
Lead & manage the MA team & investigator driven research, educational grants, medical advisory boards, HCP interactions, medical societies & patient advocacy groups & the oversight of compliant product education materials & programs for healthcare providers, internal GMS & commercial teams
Lead & manage the regional MA team performance, behavior, culture & image of MA. Perform budget reviews, staff performance appraisals and address career development needs of MA staff; motivate the team to meet the needs of both internal & external customers
Provide medical leadership & scientific strategy and support across all levels and functions in the region
Drive the lifecycle and portfolio growth agenda by focusing and aligning MA goals resources with key commercial priorities in the regions and globally with other functions as needed
Develop cross-functional medical strategies aligned with and supportive of commercial strategy; partner with the R&D and Commercial groups and provide medical insights to shape the portfolio and post-marketing strategy
Oversee the generation of de novo clinical evidence through research and the provision of literature summaries and disease area information from relevant research by others
Support the on-going education of the medical community through independent CME programs and ensuring compliant and evidence based responses to unsolicited requests for medical and scientific information
Provide a contact point for relationships with leaders in the medical and scientific community especially in the Neurology, Cardiology, Nuclear Medicine and Interventional Radiology and other specialties as determined by varying business
Inspire, channel and focus the work product of the medical advisory boards, as needed
Oversee medical input to the production of promotional material for new or existing products; oversee the medical review and approval for all advertising & promotional material
Provide input into the design and support execution & reporting of Phase IIIb-IV clinical trials in partnership with R&D as needed
Partner closely with HEOR functions to ensure that the value propositions for products in the portfolio are developed and/or enhanced
Support the development of new data through exploratory and confirmatory investigator sponsored studies
Drive publication of ISTs, new data, reviews and other communications that foster the education of healthcare providers and enrich the scientific knowledge about Core Imaging products
Oversee the development and execution of a communication strategy which properly presents the value of products and science. Ensure integration and optimization of the communication strategy at the portfolio level
Collaborate with R&D, Regulatory Affairs to develop registration strategy, including regulatory stakeholder management, submission strategies, data development and advisory committee strategy. Support label negotiations and other FDA interactions
Support compliance and interactions with regulatory authorities in support of medical product opportunities and obligations
Provide strategic input and perform medical due diligence for business development and licensing, as needed
Seek and ensure dissemination and understanding of product plans and strategies from New Product Development, the Product Segment and USCAN regional commercial leadership. Partner with and provide medical input to the development of these strategies
Provide guidance and counsel to colleagues and stakeholders to assure all activities are conducted according to local, national and global Ethics, Compliance and Legal policies and standards
Represent GEHC with integrity, professionalism and credibility in local, national and international forums, as needed
MD or equivalent degree, medical license and formal training and/or experience in diagnostic imaging and/or neurology, radiology, cardiology, oncology or nuclear medicine specialties
Minimum 10 years’ experience in R&D or Medical Affairs roles in the pharmaceutical and/or biotech industry. Medical device experience a plus
At least 5 years of experience in progressively senior roles with team management responsibilities and demonstrated history of successful team performance in MA
Depth of knowledge and experience in MA strategy development, MA methods, and associated regulatory, legal and compliance needs
Understanding of GCP and the clinical trial regulations which are applicable to clinical development
A strong understanding of “good promotional practices” as defined by PhRMA, OIG and ABPI Guidelines, and of independent medical education as defined by ACCME. Experience of promotional materials review in accordance with the appropriate regulations
Self-motivated and confident team leader/player with both strategic and tactical skills
Demonstrated line and matrix management ability, and demonstrated team leadership skills
Demonstrated ability to drive focus personal and team customer focus with an emphasis on outcomes with impact
Able to effectively manage resources for optimal effectiveness
Flexible and adaptable attitude that remains aligned with prevailing and future needs
Able to inspire and empower others by building a connection with the team through personal involvement and trust and providing feedback and coaching to help develop others
Able to make decisions with partial or incomplete information. Able to maintain momentum while adjusting course as needed to suit business needs and prevailing circumstances
Demonstrated consistent ability to perform to a high standard the elements of the role as described above
Good commercial acumen and understanding of the commercial environment
Excellent communication, training and presentation skills. Fluent in English (both written and oral); other languages a plus
Understanding of healthcare provider and customer needs, marketplace dynamics, industry trends, and the competitive landscape in the industry/function
Understanding of commercial team organization and function to allow effective and fluent interactions
Able to simplifying strategy into specific actions with clear accountability, making decisions with speed and accuracy based on best available information
Willing to travel at least 25%

Medical Affairs Specialist Resume Examples & Samples

Bachelors degree in Medicine
Post graduate study (Master Degree or Diploma) in the therapy area is an advantage
Minimum 1 year experience and up to 3 yrs post graduation in the medical field
Pharmaceutical experience is an advantage
Knowledge of the Disease Area is a plus
Experience in the Therapy Area in the Pharmaceutical Industry is a plus
Fluent in professional English language. Arabic language is an advantage
Good Computer skills (Word, Excel & PowerPoint)
Good communication skills, with high ability to convey messages successfully to all internal and external stakeholders
Provide product and disease area information to external customers. This need is met primarily through direct scientific interactions with healthcare professionals (HCPs), including data presentations and responding to enquiries
The MAS is the field-based scientific expert in the disease/therapy area(s), clinical practice and competitor landscape. Through his/her expertise and external interactions he/she will develop insights which will assist in the development and execution of innovative Medical Affairs strategies and plans that clearly support GSK development of medicines of value for patients and customers
The language and activities of the MAS must at all times reflect the medical nature of the role, be fair, balanced, non-promotional, scientific and evidence-based. MSL must ensure full compliance with GSK Code, SOPs and local laws & regulations for all country medical and promotional activities, in line with the principles of Scientific Engagement
The MAS Role operates under the direction and support of the Country Medical Director
Implement the strategic directions and all field based medical activities required for successful commercialization of the Therapy Area product portfolio within the NE markets aiming to achieve company objectives
Support the implementation of the Product Portfolio Clinical Trials program, Pharmacovigilance and Medical Affairs activities
Provide the necessary support to Marketing and Sales departments and other internal stakeholders for the Product Portfolio
Establish GSK as a key player in the Therapy Area and enhance the scientific image of GSK among Healthcare Professionals and key external experts
To support governing the ethical practices of all promotional and marketing activities in the Therapy Area with the aim to foster the ethical and scientific image of GSK as a leading pharmaceutical company

Medical Affairs Specialist Resume Examples & Samples

Demonstrate relevant protocol and product knowledge of assigned protocols with oversight and guidance from the Medical Monitor
Author and contribute to the preparation of core MA internal and external deliverables (MMPs, trackers, reports) as contracted
Provide functional oversight for MA as directed by lead MM for specific studies
Recognize potential issues relevant for MA project tasks and escalate according to the applicable procedure
Provide input and review of relevant MA tracking systems for accuracy and quality and assist with maintaining MA project files
Perform review of clinical and diagnostic data with oversight from the MM as it relates to patient safety
Liaise with investigational site and/or Sponsor as necessary regarding MA issues with oversight and guidance from MM
Liaise with safety and regulatory teams in order to facilitate open communication regarding updates on SAEs and regulatory issues
Review and demonstrate working knowledge of contract and GPT in conjunction with MM

Director, Global Dermatology Medical Affairs Resume Examples & Samples

All clinical research / development activities for products under development, and for post approval commitments such as regulatory agency mandated trials, or those intended to support product registration or to generate data for label inclusion remain the primary responsibility of TA development teams
May interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc…) as they relate to on-going medical affairs projects. Serves as the scientific team interface for key regulatory discussions
Can address complex problems within discipline/project or across disciplines. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Works on problems of diverse scope in which analysis and interpretation of data requires evaluation of multiple factors
Typically does not supervise employees but must be able to influence in a matrix environment. Works mostly independently with limited guidance
Adaptability: Maintains effectiveness when experiencing major changes in work tasks or the work environment, adjusts effectively to work within new work structures, processes, requirements, or cultures. Considers change or new situations as opportunities for learning and growth. Perseveres when encountering adversity. When confronted with a problem or crisis considers alternatives and then takes timely action. Effectively prioritizes work tasks
Innovation: Generates innovative solutions in work situations, tries different and novel ways to deal with work problems and opportunities. Uses best practice and benchmark data to increase organizational performance. Identifies opportunities to improve efficiencies and reduce costs

Senior Medical Affairs Associate Resume Examples & Samples

Assist in assigned aspects of study management for HCV investigator-sponsored and collaborative trials. Develop and track quarterly and annual reports for the HCV Phase 4 Studies Program
Provide scientific expertise into study concepts; participate in building study synopsis, protocols, and other study documents; and liaise with affiliates and investigators
Maintain regular contact with investigators to track study progress and publication deliverables; liaise with Scientific Communications colleagues to share information regarding planned publications
Review abstracts, manuscripts, posters and oral presentations for Gilead-sponsored, investigator-sponsored and collaborative studies; collate Gilead Sciences review comments and share with external author(s) and internal review committees
Serve as an information resource to Gilead colleagues, including the Medical Scientists, regarding viral hepatitis and related investigator-sponsored/collaborative studies
Participate in the HCV Publications Subteam to share information on anticipated publications from Gilead HCV phase 4 studies; maintain study timelines
Provide strategic input to US Medical Plan of Action, and monitor performance against HCV team annual goals and objectives
Serve as an educational resource to both medical and commercial disease and product training
Provide medical and scientific leadership at key scientific meetings involving HCV e.g., AASLD, EASL
Develop effective working relationships with internal and external customers, including Clinical Operations, Clinical Research, Biometrics, Commercial and Marketing, Contracts/Finance, Virology, Pharmacology, Legal, Medical Scientists and other Gilead Medical Affairs colleagues, Medical Directors/Medical Managers in affiliate offices, investigators, research organizations
Other activities, as assigned, to support HCV Medical Affairs
Experience in infectious diseases, virology or clinical virology desirable
Experience in clinical patient care desirable
Experience in developing effective abstracts, manuscripts, posters and slides and presenting at scientific meetings
Excellent teamwork skills. Organized; attention to detail and able to meet timelines in a fast-paced environment
Able to work with a level of autonomy and independence

Medical Affairs Program Manager Resume Examples & Samples

Implements standardized Molina Healthcare programs in collaboration with the integrated Healthcare Services Team including long term care and behavioral health, according to state and federal regulations
Manages Healthcare programs providing ongoing evaluation and support to ensure compliance with standardized protocols and processes
Communicates program goals and provides support for the team to achieve goals and improve outcomes
Performs root-cause analysis when identifying errors, issues and trends and provides feedback to Healthcare Services Management team for developing plans to resolve these issues. Works with Corporate Director of Training and Implementation to develop standardized materials for training purposes
Conducts Quality Improvement Audits to assess Molina Healthcare Services staff educational needs and service quality and implement quality initiatives within the department as appropriate
1-3 years

Medical Affairs Lead, Oncology Resume Examples & Samples

For developing, executing or overseeing scientifically relevant and innovative local country Medical Affairs (MA) programs
Developing and maintaining medical expertise for the relevant BI products to meet external customer needs, in combination with a thorough understanding of Marketing & Sales strategies/tactics
Supporting knowledge and skill sharing within the MA organization
Building relationships within respective functions within the local country

Medical Affairs Lead Resume Examples & Samples

Effectively coach, develop and engage your MA team, including the identification and development of key talent, identification of training needs and development of respective training plans
Develop and maintain a network with health care professionals, authorities and media
Initiate and manage clinical and scientific activities and projects
Provide therapeutic area and drug expertise to brand team and contribute to marketing strategic planning
Provide TA specific support to other functions (Medicine Operations Lead, Regulatory Affairs, Drug Safety, Market Access Pricing and Outcomes Research and Clinical Operations)
Set high standards and drive results by giving and seeking feedback

Head of Medical Affairs Resume Examples & Samples

Medically qualified with a strong scientific background. Equivalent background is also acceptable
Significant industry Medical Affairs experience gained within infectious diseases and/or other highly specialized therapeutic areas
Experience in managing a Medical team of a pharmaceutical company, at country or international level
Proven track record of working closely with commercial, R&D, and other functions in an international matrix structure
Knowledge of International, HIV, hepatitis and infectious disease markets
Fluent in Mandarin and English, both written and verbal
Demonstrable evidence of ability to work collaboratively within a matrix team environment
Excellent communication skills with internal and external stakeholders
Ability to lead and manage at a level above and below
Flexibility and appreciation for different affiliates, systems and cultural differences
Must demonstrate a willingness to learn
Ability to travel internationally up to 60% time

Medical Affairs Lead-pharmacovigilance Resume Examples & Samples

Review spontaneous reports of injury or illness to assess severity, causality and/or expectedness against applicable U.S. FDA, U.S. CPSC, Health Canada, Australia CCC and other global regulations for drugs, medical devices and consumer products, including cosmetics
Based on regional regulatory triggers and definitions, make a decision whether to report SAE’s or incidents to appropriate regulatory bodies
Submit accurate and verifiable data on serious and non-serious adverse reactions, incidents or events to the competent authorities within the legally required time limits
Prepare and submit CPSC Section 15(b), EU RAPEX and other consumer product potential hazard or product defect reports as needed
Conduct periodic review of all SAE and incident reports to inform Periodic Safety Update Reports (PSUR), Undesirable Effects Summaries (UES), Risk-Benefit Analyses, Failure Modes and Effects Analyses (FMEAs), Product Safety Clearances and other product risk and safety assessments
Use periodic safety summaries and scientific knowledge to inform updates to product formulation, design, labeling, intended use and other product features, as needed. Ensure appropriate communication of relevant safety information to consumers
Review the quality, integrity and completeness of the information submitted on the risks of drugs and medical devices, including processes to avoid duplicate submissions and to validate signals
Perform signal detection and signal management activities for drugs and medical devices
Conduct regular reviews of medical and scientific literature and vigilance databases to determine reportability and/or relevance to product safety
Contribute to the development of risk management plans if needed
Organize and participate in periodic Safety data review meetings
Develop SOPs and work instructions related to Drug, Device and Consumer Product Safety / Technovigilance to ensure ongoing compliance with regulations in key markets
Maintain a high level of understanding of applicable regulations (FDA and ICH guidance, EU Directives, Consumer Product Safety Laws, etc.) to assure adherence to all requirements
Maintain thorough familiarity with internal SOPs to ensure adherence to internal policy and process requirements
Interact with other departments (e.g., Regulatory Affairs, Clinical, Product Safety, Quality Assurance, Consumer Affairs and others) to ensure all safety reports are completed and submitted in time and in accordance with internal SOPs and Regulatory reporting timelines
Manage safety/pharmacovigilance vendors to assure timelines are met, potential issues are communicated and resolution is achieved in a timely manner
Maintain multiple internal tracking documents related to post-marketing SAE processing
BS/MS or equivalent in a health care field or RN (with clinical experience preferred) or demonstrated equivalent experience necessary to fulfill position requirements
Knowledge of global regulatory framework for aggregate safety reports is required, including GVP Modules
Minimum 7 years of pharmaceutical or CRO experience, 3 years of which are in a drug safety and pharmacovigilance role. Candidate with less than 7 years of experience will be considered if s/he has an advanced degree in a medical field
Experience in developing aggregate safety reports (e.g., PBRER/PSUR, CIOMS, UES) is required
Experience in a clinical research or clinical trial project management role is desirable
Working knowledge of medical concepts and familiarity with safety activities in drug development and/or post-marketing is required
Good oral and written communication, organizational skills and personal presentation
The ability to communicate effectively in English. Ability to write concisely and cogently
Ability to work independently with little supervision; self-motivation is a must
Strong sense of urgency and ability to continuously reprioritize
Ability to manage multiple activities simultaneously
High degree of attention to detail, organization and timely follow-up
Excellent interpersonal skills, with ability to interact / communicate effectively across various levels within the organization

Medical Affairs Associate Director Resume Examples & Samples

Function as the field based prostacyclin clinical expert relating to the preparation, delivery and administration of Actelion’s prostacyclin therapies within and outside the organization
Manage the day to day clinical operations of the Veletri Pharmacy Prepared Program including but not limited to: site management, specialty pharmacy audit/inspections, patient case management and product complaint/adverse event management
Build strong relationships with prostacyclin expert PAH nurses, advanced practitioners, pharmacists and physicians and specialty pharmacy clinical team members
Coordinate, prepare and implement internal and external training on the clinical management of patients on prostacyclin therapies focusing on preparation, storage, delivery, administration and adverse event profile
Develop medical content for advisory boards in the area of prostacyclin clinical care, preparation, delivery and administration
Collaborate with clinical staff at major PAH centers to ensure Actelion prostacyclin therapies are managed appropriately
Development of medical and scientific materials when needed for purposes of medical education internally/externally
Collaborate with Field MSL, Sales and Access colleagues to ensure safe and appropriate use of prostacyclins

Director, Field Medical Affairs Resume Examples & Samples

Defines strategic direction and oversees its tactical execution for Field Medical Affairs and ensures alignment with corporate initiatives
Clinical and scientific support of activities including internal clinical input and training to commercial functions
Ensures highest scientific standard and expertise across the MSL team in order to establish strong peer-to-peer collaborations and professional relationships
Medical presentations to both internal and external audiences within legal, compliance and regulatory guidelines
Provide appropriate mentoring and coaching to direct reports with respect to technical skills,business acumen/planning, and effective regional management and KOL interactions
Minimum of 7 years’ experience as Medical Science Liaison and 3+ years of management experience
Proven track record of success, especially in the areas of thought leader engagement, regional planning, and collaboration with other field roles
Exemplary interpersonal communication skills, both oral and written
Demonstrated ability to comprehend complex scientific, medical, and emergent business issues and modify regional commercial meetings accordingly
Ability to travel nationally as needed, as well as to home office. Estimated travel 40%

Medical Affairs Internship Resume Examples & Samples

Assist in the conceptualization of outcomes research studies by proposing various study design ideas, including critiquing options and making recommendations on the optimal design and calculating sample sizes
Participate in site selection process, from initial identification of potential sites to communicating with potential investigators and follow process through legal contracting with the site
Be the leader of research data management of at least one study
Conduct statistical analysis of research data from Medical Affairs studies using standard statistical software such as SAS or SPSS of at least one study
Contribute to the writing of technical reports or peer-reviewed manuscripts of study results
Work cross-functionally and across geographies as directed with groups such as Commercial Affairs, Global Marketing, and other Medical Affairs staff within the company
Solid understanding of the following study designs in terms of their strengths, weaknesses and when each is appropriate: randomized clinical trials, cohort studies, case-control studies, cross-sectional studies/surveys, and pre-post comparison studies
Concrete demonstrable skills in statistical analysis of all of the above study designs
Strong ability to code in standard statistical software such as SAS or SPSS
Bachelors degree in any field, math or biological sciences preferred although not required
Currently enrolled in Masters or PhD program in an accredited School of Public Health, School of Statistics, or closely related field
Have completed a minimum of 2 full semesters of coursework in the fields above
Minimally have taken at least one epidemiology course, two or more advanced courses in biostatistics or statistics
Clinical / medical background preferred but not required
Experience in microbiology strongly preferred by not required
Local candidates only

Medical Affairs Lead, OTC Resume Examples & Samples

Provide deep disease state knowledge, medical affairs expertise, a comprehensive understanding of the relevant scientific literature and treatment guidelines, and strategic medical affairs leadership to the OTC area
Develop and implement strategic medical affairs plan(s), and associated medical affairs activities, within the OTC area
Develop insights in optimization of therapy, improved clinical outcomes, and enhanced value proposition. Share insights with stakeholders and integrate into global publication and strategic plans
Identify and engage with key external experts within the OTC area, so as to ensure that external insights inform medical affairs strategic plans, and internal development opportunities
Actively engage in the planning, oversight, and implementation of OTC relevant congresses, symposia, scientific exchange meetings and ensure that all activities are compliant with Sandoz requirements

Scientific & Medical Affairs, Senior Manager Resume Examples & Samples

Contribute to the development and implementation of scientific studies and drives an aggressive publication plan through developing and managing key thought leader engagement
Regular communication with the external medical community to remain abreast of issues in the field and to provide support and direction to them
Attends major conferences and helps coordinate scientific affairs activities at conferences, including presenting to external audiences as needed
Establishment and management of KOL networks
Generating technical notes, white papers, peer reviewed publications in support of product launch
Reviewing marketing, advertising, promotional, scientific and sales collaterals for scientific accuracy and content
Collaborates with product management, downstream marketing, clinical and regulatory affairs as well as commercial teams in multiple areas including publication planning, speaker education programs, manuscript review and conference and local meetings preparations
Participates in relationships with vendors, consultants, contractors and professional associations as appropriate to keep informed of existing and evolving industry standards and technologies
10+ years of related experience spanning analytical chemistry, automation, LCMS and immunoassays
Excellent interpersonal, organization, communication and influencing skills
Experience in risk management/safety assessments in the medical device industry

Medical Affairs Resume Examples & Samples

Perform data integrity reviews on trial data in the IIT Medical Affairs Global Enterprise (IMAGE) Database to maintain high data quality; review, validate and manage data cleaning activities; identify data trends and patterns within IMAGE for timely resolution
Collaborate with internal Celgene functional teams to identify, track and modify data and implement fixes as needed
Manage internal customer requests or other duties in support of special projects as needed
Gain insight to the drug forecasting requirements for IITs and the current Medical Affairs drug forecasting methodology; assist with quarterly drug forecasting activities as needed
Assist with the maintenance of Celgene’s IIT safety notification system
Manage and process IIT study budgets and milestone payments
Ensure completeness of IIT document repository as it pertains to essential documentation in preparation for internal audit
Perform technical and scientific literature searches as required
Currently pursuing a Bachelor’s degree in science with an anticipated graduation date in the next 2 years
Ability to work independently with good organizational skills
Proficient in Microsoft Office (including Excel, Word, PowerPoint)
Some exposure to data systems and data handling activities is preferred
Must be available for full-time employment for 10-12 weeks during the months of June-August

Medical Affairs Resume Examples & Samples

Board certified physician, with current Maryland licensure free from restrictions or limitations
DEA registered
CDS licensed
Graduation from accredited school of medicine, and successful completion of residency program (primary care preferred); MBA, MHA, or equivalent, preferred
Minimum of five (5) years of clinical experience, preferably in community based practice
Experience in overseeing work of other professional staff
Physician practice management or care coordination experience
Strong strategic thinker and problem solver, with results oriented focus
Experience in negotiation and conflict resolution
High tolerance for complex, ambiguous and constantly changing environment
Strong customer service skills and patient centered attitude

Medical Director MD, Medical Affairs Resume Examples & Samples

Act as team lead and primary contact from U.S. Medical Affairs regarding the medical strategy, plans, and programs for assigned hematology molecules. Guide the medical team(s) to ensure strategies, plans, goals, objectives and targets will be met or exceeded
Work with the team and others to develop strategies, plans and programs for Sponsored and Supported clinical trials. Lead the review of all proposals for supported trials
Analyze, present, and interpret study data, with integrated assessment as compared to published data
Lead exploratory data analysis to address additional medical data gaps for relevant molecules
Where assigned, lead hematology launch strategies and ensure execution of those strategies
Represent Medical Affairs hematology disease area on multidisciplinary Genentech and Global Roche teams
Act as an expert advisor to internal committees, management and teams regarding strategic medical issues and lifecycle planning
Provide expert leadership, guidance, and input into Lifecycle Management, Lifecycle Plans, 3-year and 1-year brand/tactical plans for hematology area
Where assigned, serve on Joint Working Teams with external partners

Medical Affairs Resume Examples & Samples

Understand high level aspects of the drug development process, including protocol design and implementation, as well as data review and interpretation, and results reporting
Understand ICH guidelines for good clinical practice (GCP) in relation to clinical trial conduct
Acquire an understanding of the interaction between Medical Affairs and other departments
Participate in 1:1 meetings with team members in other departments to be exposed to their functions and to appreciate the cross-functional relationship between Medical Affairs and other business partners, or how other departments function; to include but not limited to (Minimum 3 to 6)
Apply effective oral and written communication skills, problem solving skills, as well as interpersonal skills into daily internship activities in the business setting
Advance development of personal characteristics of behavior and professional attitudes reflective of high moral and professional standards, emotional maturity, and personal and professional integrity
Assists Scientific Lead and/or Disease Lead in making recommendations, taking action and providing clinical research input related to projects
Assists the Scientific Lead and/or Disease Lead to interface with project team members including: Clinical Research, Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management
Assists with preparation of key medical affairs documents
Assists in IIT protocol review and prioritization if applicable
Assists with organization and review of ongoing summary data including: safety, primary efficacy variables, and laboratory data
Should have a minimum of 1 year of full-time college completed with a major in a science-related field
Should have an interest in pursuing a career in the pharmaceutical industry
Should possess self-motivation and flexibility with regard to daily attendance, assignments, deadlines, and workload

Director of Medical Affairs, MS, Aubagio Resume Examples & Samples

M.D. board certified/eligible
PhD with background in MS and Medical Affairs will be considered
Neurology board certified/eligible
The title and position will be based on experience and qualifications
Outstanding scientific acumen
Excellent written and verbal communication
Proven success within a matrix environment
Collaborative and transparent leadership capabilities
Strong analytical approach to problem solving
Creative and innovative thinking #LI-GZ

Director of Scientific & Medical Affairs Resume Examples & Samples

Represents the company to groups of experts including medical professionals, societies, and regulatory agencies at scientific meetings
Responds to and maintains proper records of response for technical information
Participates in industry wide organizations such as standardization consortiums and professional associations
Develops Customer Education Programs
Develops training Information for Technical Sales Consultants
MD and/or Ph.D. with significant knowledge of IVD industry, IVD technology, clinical laboratory science and medicine
Respected industry scientist who is equally comfortable working with executives, clinicians, regulatory agencies, and scientists
Diagnostic industry experience
Experience in planning, conducting and reporting clinical marketing studies, summarizing and presenting of scientific data

VP, Medical Affairs SCH Resume Examples & Samples

Demonstrates effective change management skills
Develops, monitors and continually improves systems and processes to ensure the highest quality of care, patient safety and evidence-based medical standards
Participative leadership style, personable and approachable
Gains medical staff support when developing, implementing, and promoting projects, ventures and programs. Effectively represents physician and administration views
Builds effective relationships across the organization to include board of directors, medical staff, senior management, clinical leaders, staff and patients
Communicates effectively (written, oral, one-on-one, groups), has strong follow through
Prioritizes and manages multiple initiatives and tasks for him/herself, and others in an effective manner

100

VP, Medical Affairs Resume Examples & Samples

Promotes a patient-centered healing environment
Promotes the use and implementation of technology in the workplace in order to streamline operations, facilitate communications and optimize work processes
Demonstrates skill in conflict resolution, problem solving, negotiation and teambuilding
Maintains a working knowledge of applicable national, state and local laws and regulations, DNV, JCAHO, NCQA and other regulatory requirements affecting the medical and allied health staff

101

Medical Affairs Future Leaders Programme Resume Examples & Samples

Bachelor degree on Medicine
Graduation on medical residency, Post Graduation or Specialization from July 2015 to June 2017
Previous experience in clinical practice, even during the specialization, as well as experience in clinical trials is desirable
Fluent in English (Spanish desirable)
Learning agility, Leadership, GSK expectations

102

VP for Medical Affairs & Dean Resume Examples & Samples

Evaluates and manages leadership personnel of UI Health Care including Senior AVP and CEO for UIHC, AVP for Finance and CFO for UIHC, and UIP Executive Director
Develops a comprehensive system within UI Health Care for strategic performance management for internal use and for use by the President and the Board of Regents
Provides oversight for the clinical enterprise within the missions of patient care, education and research
Co-chair with the Executive Vice President and Provost the Health Sciences Policy Committee
Oversees financial integrationof UIHC entities
Within UI Health Care, maintains direct responsibility (or accountability for delegated responsibilities) for personnel salary approvals, human resources, strategic and business development planning; direction of clinical delivery systems, management support services; overall management of patient care contracting objectives and goals; development of capital and operating budgets which maintain the financial integrity of UI Health Care; and managing relationships with affiliate organizations
Creates an All-Funds budget for UI Health Care.While each unit will maintain the necessary and desirable unit budgets for purposes of meeting reporting and regulatory expectations, funds from each unit will be applied in a fashion that advances the overall mission of UI Health Care in an optimal fashion consistent with the broad mission of the organization
Aligns within the strategic plan and within operational planning and budget all aspects of patient care
Participates in major external and internal governing bodies of UIHC, CCOM and UIP
Approves all major shared service and purchased service agreements among UI Health Care units and with the general University
Partners with health sciences colleges on academic issues of mutual interest
Provides the UI President, other UI institutional officers, the Board of Regents, State officials, and policymakers information and authoritative advice on statewide health care issues
Serves as the external liaison for related organizations such as UI Health System, Inc
Aligns fundraising plans to cover all aspects of private support for UI Health Care and to increase private support for UI's health care delivery programs
Serves as principal liaison to the University of Iowa Foundation for development
In collaboration with the executive dean and Senior Associate Vice President and CEO for UIHC, gives special attention to the recruitment and retention of women and minorities
Creates an environment of trust and collaboration to enable the recruitment of world-class physicians, nurses and all other health care professionals
Interacts with state and national leaders in health care and academic medicine
Basic & Specific Responsibilities: Dean CCOM
Evaluates and manages leadership personnel of CCOM, including Executive Dean
Directs CCOM short- and long-term strategic planning
Aligns within the strategic plan and within operational planning and budgeting all aspects of medical education (including student affairs, admission and placement of students, academic program development), other educational programs within the clinical setting, and research
In collaboration with Deans of Health Sciences, develop academic programs for inter-professional education
Oversees

103

Director UK Medical Affairs Resume Examples & Samples

M.D (in life sciences, immunology, vaccinology, infectious diseases, public health and/or epidemiology)
Recognized experience and expertise in medical affairs and teamwork. Ideally includes experience managing external experts and interacting with EE’s and organising activities involving EEs
Knowledge of the Pharmaceutical and/or Vaccine Industry; broad understanding of the different disciplines involved, with a sound knowledge of life sciences & vaccination: vaccines, infectious diseases, immunology, preventive medicine and public health
Pharmaceutical Industry experience is considered an asset
Specialty in immunology, infectious medicine, epidemiology or other relevant specialty is considered an asset
Basic knowledge of budget and account management
English fluent

104

VP, Medical Affairs Resume Examples & Samples

M.D. is required
Strong leadership, organization, management, communication, negotiation, and analytic skills
Five (5) or more years clinical practice experience
Considerable medical experience in one or more branches of medicine or surgery and leadership and administrative experience in a medical department, medical staff, or health care organization

105

Medical Affairs Insights & Analytics Manager Resume Examples & Samples

BS/BA, in Business/Marketing or a Health Sciences related field
Minimum 5 years of relevant experience working within the pharmaceutical industry, as well as exposure to the common interaction-points between medical and commercial partners
Solid business analysis skills with experience integrating primary and secondary data to drive insight; ability to efficiently synthesize large amounts of qualitative and quantitative information into relevant business insights
Demonstrated strategic thinking and decision-making skills, with ability to determine unmet needs and deliver meaningful insight
Strong communication, influence and presentation skills, both written and verbal; able to communicate complex ideas to others
Proven ability to manage multiple priorities, and keep projects on track to meet deadlines
Comfort navigating internal market research policies, processes and systems to track, manage and execute projects compliantly
MBA or Advanced Degree in related fields with emphasis in quantitative research/analysis methods
3+ years of experience in a market research or analytics role delivering insights for medical affairs operations
Prior HIV therapeutic area experience and/or specialty market experience preferred
Advanced analytical modeling skills and experience with relevant business intelligence / analytics tools commonly used to analyze market research data

106

Medical Affairs Excellence Manager Resume Examples & Samples

Minimum education level BSc or equivalent
Medical Affairs experience as a Medical Science Liaison, Medical Advisor or Scientific Advisor
Experience of training materials design and delivery
Project management of multiple projects in a fast moving environment
Excellent influencing skills
Expertise in adult learning principles
Formal Learning & Development/HR qualification or equivalent
Experience working in Franchise at a global level
Maintenance of all the disease and product medical curricula and creation of new curricula as appropriate
Communication about all curriculum changes to the LOCs and the Medical Affairs Excellence Directors
Successful delivery of new Global S&PE training materials
Contributing to the creation of Franchise training plans
Project managing delivery of materials & meetings by partnering with Franchise Subject Matter Experts (SMEs), Global Learning & Development (GL&D) and external vendors

107

Operations Director, Latin , Medical Affairs Resume Examples & Samples

Accountable to the US Medical Affairs Head for all operations across the US portfolio, creating an environment of co-operation and mutual respect across the functions to achieve US Medical Affairs objectives
Serves as a senior member of the US Medical leadership team responsible for strategic planning, goals and outcomes related to operations, playing a critical role in supporting governance to enhance leadership team decision-making and trade-offs across the portfolio
Under the direction of the US Medical Affairs Head, supports, contributes, and evolves the US Medical Affairs Mission and Change Management Vision
Supervises the goals and development of direct staff. Provides appropriate challenges to staff and teams to achieve portfolio objectives and goals in spite of adversity or roadblocks. Participates in the Performance Management process for reporting staff members
Drives the development of an integrated US Medical Affairs portfolio budget that aligns team, functional, and US resources, keeping a minimum of 8 quarters in planning horizon. Performs financial and headcount planning & management across US Medical Affairs, ensuring budget issues are identified and communicated to US MA leadership
Accountable for the optimization of key US business processes, i.e., Key Account Management (KAM), Data Generation, In-field Ways or Working, etc., by ensuring connectivity of strategic outputs to the business units across US Medical Affairs
Facilitates the creation of a comprehensive scorecard to enable accurate and timely access to US MA Portfolio information and accountability for Execution Excellence
Acts as the senior operations leader with other US business stakeholders, such as US CA&O
Reinforces the appropriate change control processes are in place for the US MA tactical plans and outcomes communicated, and notifies leadership of learning opportunities and process improvements opportunities
Manages the agendas of US Senior Leadership Meetings and other key operational meetings. Ensures effective meeting management principles are implemented within the senior US Leadership team and that meetings are conducted and facilitated in a manner that brings resolution to issues

108

Senior Director, Field Medical Affairs Resume Examples & Samples

Oversees tactical execution of the Field Medical Affairs element of the Integrated Medical Plan for bremelanotide, including laying the foundation for the company to interact with KOLs and Societies in the field of Female Sexual Dysfunction and Hypoactive Sexual Desire Disorder
Direct management responsibility for the AMAG Medical Science Liaison team (8 US regions) including recruiting, hiring, and retaining qualified candidates
Provide regular field updates and insights to internal stakeholders in home office
Involved in creation of training materials for the relevant therapeutic areas, especially for the fields of Female Sexual Dysfunction and Hypoactive Sexual Desire Disorder
Ensure MSL team function in line with MSL Work Practice Guidelines; develop metrics to track success of MSL team
Ensure strong collaboration with other AMAG field roles via regular communication with other field leadership
Provide appropriate mentoring and coaching to direct reports with respect to technical skills, business acumen/planning, and effective regional management and KOL interactions
Minimum of 10 years experience as Medical Science Liaison and 5+ years of management experience
Successful record of hiring and building new MSL teams
Experience in maternal and/or women’s health and a well-established KOL network is strongly preferred
Successful record in supporting Managed Care functions (e.g. influential in changing a market access position)

109

Director of Medical Affairs Resume Examples & Samples

To provide Medical Affairs leadership to the incumbent’s local and regional Medical and Scientific Affairs teams across Europe, Russia/CIS and Australia/New Zealand
An ability to support existing local and global brands whilst guiding global best practice
Experience of people management and offering clear strategic guidance
Experience of managing teams, working effectively in a matrix structure and working at an international level
A strong science, pharmacy or medical degree with broad level medical, pharmaceutical or consumer health care industry knowledge and experience is required
Broad knowledge of international regulatory frameworks as they relate to medical and clinical requirements for product registration and clinical research
Experience of partnering with commercial colleagues in markets and a strong understanding of Corporate and operational business issues

110

Medical Affairs Program Manager Resume Examples & Samples

Facilitates and manages successful execution of medical affairs efforts
Develop program and project plans, timelines/schedules, estimates, resource plans, and monitor and report out status
Support development, review and approval of external collaborations
Establish foundational program management framework and processes to support medical affairs
Monitor, track, and report performance of accountable initiatives including development and establishment of program metrics and measures
Manages risks, resolves issues, and takes corrective actions to ensure initiatives progress as expected
Engages the organization cross-functionally to support efforts related
Identifies, evaluates, and oversees appropriate vendors and contractors that may support efforts

111

Medical Affairs Resume Examples & Samples

Medical Doctor with board qualifications in Rheumatology is required
Academic experience (+10 years) in Rheumatology
Record of proven record of publications and communications and experience with medicine development
Experience in Rheumatology, SLE & Vasculitis. Patient experience with belumumab preferred
Has practical and broad working experience in the US with an established broad network of experts in Rheumatology
High level of ethics and integrity
Pharmaceutical experience in R&D or Medical Affairs position and/or experience in external HCP Interactions between HCPs and Pharma/BIO Industry is an asset
Exceptional oral and written communication skills; strong presentation skills
Demonstrated ability of strategic planning
Demonstrated ability to work across boundaries and geographies effectively
Ability to navigate complex data and challenging situations to work through to effective solutions
Customer oriented/ Service oriented; mature; calm under pressure
Ready to coach, to support others
Operate effectively in multicultural matrix organization; networks readily
This position will be field based (with approximately 70% of the time spent in the field)
Externally Engage with High Profile External Experts
Deliver Promotional Presentations (Branded and Unbranded)
Actively participate in Ad Boards
Partner with Health Outcome Liaisons/MSLs/Health Policy Liaisons to see/present to certain customers (eg. Health plans, hard to see external engagements)
Provide internal training for Therapeutic Area as requested

112

Senior Medical Affairs Information Specialist Resume Examples & Samples

Defines literature search protocols and literature search queries, executes literature searches in accordance with the search protocol, and screen titles, abstract and full text of publications from the literature search for clinical data on specified medical devices in accordance with inclusion/exclusion criteria set out in the literature search protocol
Collaborates with internal subject matter experts to interpret and summarize clinical data from medical and scientific literature during the screening and data extraction steps of the systematic literature review process
Puts metrics in place to measure usage and effectiveness of the Library Information Management Systems
Provides training on using information resources, copyright compliance, intellectual access and digital rights management and bibliographic referencing and procurement; evaluates and recommends new information resources, platforms and search tools
Maintains and updates virtual library
Participates in meetings and professional conferences
Oversees the work of contractors supporting the unit

113

VP, Medical Affairs Resume Examples & Samples

Establishes and provides strategic leadership for all US Medical Affairs activities and initiatives in support of CNS portfolio products and development compounds for the Psychiatry and Neurology Franchises
Provides leadership to and oversee hiring, training and managing of the US Medical Affairs Leadership Team including the Medical Science Liaison team
Monitors budget preparation and timelines, ensuring effective fiscal utilization per budget for US Medical Affairs
Ensures all Medical Affairs initiatives are aligned with overall brand plans and are in compliance with corporate polices and regulatory requirements
Ensures optimal interaction, collaboration and alignment with Lundbeck Global Medical Affairs and alliance partners regarding Medical Affairs strategies and activities
Identifies, establishes and maintains collaborative relationships with key stakeholders including investigators and institutions
Ensures effective scientific and medical communication on Lundbeck CNS portfolio products and pipeline compounds to Key Opinion Leaders (KOL’s), academic and scientific organizations, payers, government and regulatory bodies in the US
Oversees the strategy and implementation of KOL activities including advisory boards
Develops and leads the scientific exchange process
Represents US Medical Affairs at medical meetings, advisory boards, symposia and outreach meetings
Ensures appropriate medical input and review on promotional material/activities
Ensures appropriate medical input and review on business development and relevant clinical programs as needed
Defines and implements best practices for the US Medical Affairs team
Accredited Doctorate Level Degree
At least 10 years of Medical / Scientific Affairs experience successfully leading cross-regional and cross-functional teams within the pharmaceutical or biotech industry
5+ years of management experience
Excellent understanding of US regulations and compliance rules for pharmaceutical industry regarding Medical Affairs functions
Established long term relationships with identified U.S. KOL’s with proven ability to achieve scientific, educational and business goals
Well established leadership skills to attract talent, motivate and maintain a high performance culture
Proven ability to effectively manage relationships, and influence internal and external stakeholders, customers, and partners
Highly collaborative and team-oriented; values input
5-7 years of management experience with US Medical Affairs team(s) in Neurology or Psychiatry
M.D. degree (Doctor of Medicine)
Proven track record in establishing and executing Medical Affairs strategies and activities
Strong background and breadth of experience in market access and strategic pricing of products
Board Certification in Central Nervous System (CNS) specialty

114

VP, Medical Affairs Resume Examples & Samples

Leadership of All Medical Affairs Therapeutic Areas, Medical Information and Medical Education Departments, Field Based Medical Science Liaisons and Scientific Affairs team
Support BD with medical input and guidance to company objectives
Communicate and collaborate with commercial colleagues for the development of marketing and lifecycle management strategies
Provide medical and strategic input during the medical evaluations of new business opportunities
Interacts with clinical development to add specific expertise and drive commercialization of new products
Strategic input into the design, development and management of late-stage clinical studies
Participate in the evaluation of late-stage clinical study and additionally explore/recognize/pursue trends in the data
Interpret clinical and non-clinical study data in the context of existing literature and write/publish results
Compile published in-house data for descriptive and teaching presentations
Contribute/develop topics for quarterly Medical Affairs/Sales Training purposes
Participate in multidisciplinary projects designed to support the commercialization of Ferring products in US
Create relationships with the medical community that support the scientific and marketing efforts of the company
US Spokes-person for products commercialized in US by Ferring

115

Senior Director, Urology Medical Affairs Resume Examples & Samples

Manage US-based Medical Directors and Medical Science Liaisons who support independent and company-sponsored study collaborations, provide medical education and clinical support to physicians and thought leaders, and support medical training to field commercial personnel
Develop and manage strategic plan for engaging top tier national thought leaders, including physician leaders of cooperative study groups, urology professional societies, and large urology group practice associations
Develop a national medical affairs strategy in support of commercial goals for the GPS assay product
Act as primary senior level contact for investigators interested in developing and performing independent studies with the GPS assay
Oversee medical content development for clinical presentations disseminated to external speakers for medical educational purposes and for use internal use in sales training programs
Oversee medical support to Customer Service and provision of medical information in response to inquiries from academic, community, and healthcare providers regarding clinical use of assays. Inquiries may involve specific patient cases requiring facilitation of reviews through company’s team of pathologists
Represent medical perspectives to company’s commercial, operational, communications, long range planning, and business development initiatives in urology
Manage strategic plan for investigator initiated and collaborative studies, providing support as needed in study design discussions, protocol development, study operations, analysis, and preparation of abstracts and publications
Provide Scientific and Medical presentations and dossier reviews for regional and national managed care and reimbursement objectives
Provide team leadership and direction, people management and people development for direct reports
Provide scientific support for medical educational initiatives, medical congresses as necessary and facilitate the development of faculty speakers
Provide medical review and edits for all educational and promotional materials
Assure compliance with relevant corporate and regulatory guidelines
At least 10 years of industry experience
Strong collaboration and active listening skills
Therapeutic experience/expertise in urology, oncology and/or diagnostics preferred
Preferably possesses an established relationship network of physicians involved in treating prostate cancer
Ability to independently deliver quality results in a timely manner

116

Medical Affairs Associate Resume Examples & Samples

Create, track and manage medical information, including Standard Response letters and fulfillment of ad hoc requests
Research and respond to unsolicited requests for medical information from health care professionals regarding the company's marketed products (clinical and technical)
Maintain an in-depth understanding of product knowledge, labeling, and relevant data for company products and maintains current awareness for the published literature
Act as a liaison with Commercial, Marketing, Sales, Development, Safety, and Regulatory Departments for medical information on company marketed products, as well as products in development, providing due diligence materials for quality investigations and business development opportunities, and factual support of marketing pieces
Support and manage company’s medical information booths at scientific conferences and congresses
Responsible for review and approval of promotional material for fair balance (benefits vs. risks)
Receive, process, peer review and contribute to the investigation of product quality complaints
Knowledgeable of all pertinent medical information publications, requirements, and guidelines on medical communications/information
Interact with the Quality, Safety and Regulatory Departments to resolve safety and quality issues
Maintain a courteous, cheerful and cooperative demeanor at all times, with both internal and external customers
A bachelor or advanced graduate degree in a scientific field. Mater degree/PhD in science, PharmD and RN are highly desired
Previous working experience in medical information / medical affairs function in pharmaceutical companies and ideally in oncology and hematology fields is highly desirable
Good people skills are essential, this is consumer facing position that directly represent the company externally
Be well-organized, be able to quickly find relevant and accurate information
Be a good, clear communicator with an excellent telephone manner. Excellent written and verbal communication skills are required
Knowledge of PC systems and Microsoft Office (Outlook, Word, Excel) and PowerPoint are required
Ability to multi-task is required
Must be available to work in the evenings and weekends, as required

117

Medical Affairs, Region Europe Resume Examples & Samples

Responsible for the development of the regional medical plan based on the strategic direction set by the Head EUCAN Medical Affairs of IBD
Act as a key contributor in to the development of IBD therapy business strategy, working closely with medical, commercial and market access colleagues across the company
Provide medical and scientific insights to both internal and external stakeholders
Ensure operational collaboration with other departments for Therapeutic Area(s)/ Takeda products of responsibility (e.g. Market Access, Marketing & KAMs and other internal stakeholders) to develop cross-brand therapeutic strategy
Ensure the correct interpretation and communication of scientific data of IBD products
Develop and maintain important relationships with Key Opinion Leaders and external organizations to enable the company to be seen as an industry leader within IBD
Create and implement the therapy plan based on the vision set by the Head EUCAN Medical Affairs of IBD and in consultation with commercial and market access colleagues
Liaise between the Head EUCAN Medical Affairs of IBD and other functional leads within the EUCAN Medical Affairs team to ensure the functional objectives are aligned to the therapy area vision and strategy as set by the Head EUCAN Medical Affairs of IBD
Responsible for the preparation of product specific medical and scientific information documents and materials
Contribute medical input into commercial and Market Access strategy and provide overall medical support for operations in therapeutic area
Work closely with clinical, commercial and regulatory colleagues on pre-launch planning, including strategic evidence planning and generation
Assess scientific accuracy and validity of promotional and non-promotional material and its compliance with Takeda standards, SOPs and national laws
Develop comprehensive mapping and planning of regional KOL engagement in close collaboration with local affiliates (LOCs) and Global Medical Affairs, drive and track the implementation and benchmark success
Responsible for fostering communication between KOLs and external contacts in order to provide guidance education and assistance to HCPs, support strategies for publications
Work closely with the EUCAN Medical Data Generation team to ensure therapy strategy is reflected in the development and implementation of research studies and support the EUCAN market needs
Continuously screen, review and analyse scientific literature; generate summaries & critical assessments if appropriate. Provide appropriate strategic and operational input into company objectives
Leading member of the regional medical affairs team
Present, as appropriate, the clinical evidence to internal and external stakeholders in a non-promotional way, e.g. reimbursement bodies
Assist market access, if requested, with regard to medical content in health technology assessment and value dossiers
Be an expert for the allocated product and therapy area, providing medical advice to external stakeholders and internal colleagues, such as other departments within the EUCAN regional office and LOC/MCO medical teams team
Maintain up to date knowledge of developments within IBD, regulatory guidelines and company SOPs
Keeping the Head EUCAN Medical Affairs of IBD up to date on relevant medical plan projects or clinical issues within the organisation
Budget responsibility and planning for medical affairs activities related to therapy area/product
Ensure awareness and communication of medical activities to other departments within the regional and local organizations
Participate in regional product committees and brand planning cycles; owner of medical part of brand plan
Minimum of 3 years’ experience working in IBD, Gastroenterology or Immunology or a directly related clinical field or clinical development
Prior experience in Medical Affairs in pharmaceutical industry, LOC experience an asset

118

UK Director of Field Medical Affairs Resume Examples & Samples

Medical Degree or Scientific Degree
Excellent knowledge of the UK healthcare system
Experience of dealing with market access challenges relating to the UK healthcare system
Prior experience in a standalone Medical Affairs or Medical Science Liaison leadership role
Budget management experience
Respiratory Medical Affairs experience
Lead, manage and coach the field based MSL team to help deliver the GSK mission and to ensure achievement of business objectives. This will include
Setting team business strategy, objectives and priorities that drive performance. This will be done in partnership with Respiratory Therapy Medical Director
Providing 1:1 coaching and field based assessments for team members
Conduct regular review and appraisal of performance
Providing support for the personal and professional development of team members (GMC revalidation and training for Pharmaceutical Medicine Speciality, etc.) as appropriate
Creating an environment and culture conducive to ethical and successful implementation of all agreed business objectives
Driving the provision of accurate field medical information to facilitate appropriate market access and to ensure engagement of relevant Healthcare Professionals
Developing the strategic direction of the team, by considering the roles and structure required to deliver the business objectives and meet customer needs
Accountable and provide leadership for the therapy area alignment, management and deployment of the cross portfolio Field Medical Affairs team
Responsible for implementing the Medical Affairs Plan of specified Therapy Team strategies, driving a consistent approach to carrying out scientific engagement activities in the field; ensuring compliance with all relevant regulations and GSK policy
Has an understanding of the relevant therapy areas, GSK pipeline assets and of the changing healthcare environment in which GlaxoSmithKline UK operates
Providing authoritative opinion on medical and ethical matters to support the evidence-based use of GlaxoSmithKline medicines and ethical conduct of GSK sponsored or supported research; and compliance with the relevant statutory requirements (e.g. ABPI Code of Practice, Medicines Act, and EU Directives)
Build strong relationships and partnership with the Therapy Area, and cross-functional teams in order to provide leadership and direction to ethics and medical governance matters in the field
Instil a culture of clear communications that support information gathering from customers for inclusion in therapy area plans
Ensure ethical engagement of Healthcare Professionals and work with stakeholders to ensure relevant company policies are followed
Support clinical research activities, for example; Engage with Clinical Research Director and Therapy Medical Director to identify opportunities to utilise Field Medical Affairs resource to support the UK Clinical research agenda
Ensure Field Medical Affairs team members are trained to the appropriate level required to support feasibility and clinical trial recruitment conversations at sites

119

Senior Medical Affairs Specialist, Operations Resume Examples & Samples

Responsible for leading the overall prioritization of departmental projects, tracking progress and supporting communications to senior leaders
Issue and communicate project status to stakeholders as appropriate; manage project issues/risks in a timely manner, escalating when necessary
Lead the development of program budgets; supports the Mylan financial reporting process by developing the monthly accrual report for departmental vendor projects
Lead the development of the departmental spend forecast for Mylan Finance; recalibrate forecast as needed; address variances by documenting deviations from forecast assumptions. Forecast development and actual reconciliation; liaise bi-weekly with budget lead on status
Lead the collection of global metrics related to departmental projects, support the management of on time submission of monthly reports in connection with the Medical Affairs Manager of Operations
Manage the Mylan Specialty, L.P. Educational Grant program, ensure timely Medical Director and Committee Review as well as management of the Grant portal
Bachelor's degree or equivalent required and 4+ years’ experience of Pharmaceutical, Biotech or Clinical (e.g. hospital setting/patient care) industry
CAPM Certification Preferred
Must have excellent verbal and written communications skills as well as analytical, project management and problem solving skills
Must have excellent planning, organizing, follow-up skills and excellent interpersonal skills
Ability to work with a diverse group of partners from different geographic areas
A self-starter driven to deliver quality results on time and in a highly ethical and professional manner
A consummate team player with demonstrated ability and desire to function in a fast paced, changing and interactive environment
Excellent communicator with the ability to engender trust and establish credibility across the Global Medical organization
Strong computer skills, including Microsoft Word, PowerPoint, and Excel
Sedentary. Minimal handling of light materials and tools, lifting up to 10 lbs. May involve walking or standing for brief periods of time.Can understand technical documents and can communicate description of problems and solutions

120

Medical Affairs Resume Examples & Samples

Lead the scientific efforts in Solid Tumors in the EUCAN (Europe & Canada) Region
Plan life cycle research aligned with global strategy and ambition, aiming to position the Solid Tumors portfolio in EUCAN to provide maximum benefit to patients
Provide expert medical/scientific strategic and operational input into core EUCAN Medical Affairs activities such as: health-care professional/provider interactions (Payers, Patients, Prescribers and Providers); generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, data, guidelines and value proposition); patient safety initiatives (risk minimization activities /safety surveillance activities)
Responsible for the development of the regional medical plan aligned with the strategic direction set by the Integrated Brand Team and the VP Medical Affairs EUCAN
Act as a key contributor in to the development of Solid Tumors business strategy within the Integrated Brand Team, working closely with medical, commercial and market access colleagues across the company
Provide authoritative opinion on medical and ethical matters to support colleagues across the regional organization
Ensure operational collaboration with the Global Business Unit Oncology, other departments for Therapeutic Area(s)/ Takeda products of responsibility (e.g. Market Access, Marketing & KAMs and other internal stakeholders)
Ensure the correct interpretation and communication of scientific data of products in scope
Develop and maintain important relationships with Key Opinion Leaders and external organizations to enable the company to be seen as an industry leader within Solid Tumors
Assist with all elements of new product launches requiring scientific expertise
Work closely with VPs Global Oncology and EUCAN Medical Affairs to define a research strategy and a strategic lifecycle plan for EUCAN Solid Tumors area and products
Drive EUCAN Solid Tumors Medical Affairs activities, generation and dissemination of data supporting overall product, scientific and business strategy
Analyse and maximise all available scientific & epidemiologic data to best inform post-launch research strategy
Support generation of internal data, while also collaborating with external researchers to generate real-world data with a focus on meeting the EUCAN market needs in terms of access requirements, as well as regulatory needs
Develop innovative research concepts for clinical data generation; provide relevant scientific and technical training
Plan and implement best possible dissemination of generated data to deeply engage with the scientific community
Write and review (RWD) study protocols and publish in impactful journals with support of Takeda EUCAN Medical Affairs team
Act as a key collaborator and contributor to the Integrated Brand team for product brand plan development and ensure consistency of product strategy and value positioning
Deliver scientific presentations to support strategy for Solid Tumors products to internal stakeholder across departments and external medical community
Develop and maintain relationships with key opinion leaders across EUCAN
Serve as point-person with Global Medical Affairs on Solid Tumors initiatives
Represent EUCAN needs and strategies at global meetings; active member of respective leadership and project teams
Participate in design and execution of clinical trial safety, product safety and risk management plans
Oversee scientific/medical education of investigators, clinical monitors, and team members related to therapeutic area or disease specific information
Keep up-to-date on professional information and technology through conferences and/or medical literature and act as a therapeutic area resource in Solid Tumors
Develop comprehensive mapping and planning of regional KOL engagement in close collaboration with LOCs and Global Medical Affairs, drive and track the implementation and benchmark success
Responsible for the planning and implementation of Advisory Board Meetings and scientific encounters
Attend relevant conferences and scientific meetings to maintain and develop a network of contacts with specialists and customers
Maintain up to date knowledge of developments within Solid Tumors, regulatory guidelines and company SOPs
Participate in development of patient services and healthcare solutions
Ensure awareness and communication of medical activities to other departments within the global, regional and local organizations
Participate in global and regional product committees and brand planning cycles; owner of medical part of brand plan
Work closely with internal stakeholders including Marketing, Market Access, Regulatory, Strategy and Compliance
Medical Degree
Minimum 3 years’ experience working in Solid Tumors / Oncology, with deep targeted therapy experience in lung cancer (specifically NSCLC) highly preferred (other targeted therapy such as EGFR experience is a plus)
Experience in pharmaceutical product launch a plus, especially for orphan indications
Experience with development of patient services and healthcare solutions
Commercial acumen and the ability to influence others
Strong collaboration and problem solving skills
Excellent relationship management

121

Executive Assistant, Medical Affairs Resume Examples & Samples

Effectively and proactively manage the Vice President’s calendar, appointments, and office filing/organization
Coordinate domestic & international travel, hotel accommodations, meeting schedules and expense reporting for Vice President and select direct reports
Answer/screen calls for Vice President
Pre-plan and execute on- or off-site customer meetings
Proactively coordinate all department meetings and manage special projects
Facilitate interview schedules for department positions
Interact professionally with all levels of Edwards employees, customers, vendors, and legacy founders
Provide administrative support to department to include: Office supply orders, catering requests and other vendor requests as needed
Prepare, maintain, generate and process essential documents and records (e.g., expense reports, check requests, and CPAs); make travel arrangements for staff and key visitors
Coordinate department budget and work with finance group to assure monthly, quarterly, and annual budget targets are met

122

Coop-medical Affairs Resume Examples & Samples

Assist with day-to-day activities in the medical information department
Examine components of research literature, including study design, methodology, results, conclusions, and clinical significance, for appropriateness, accuracy, and completeness
Pharmacy student pursuing a PharmD in at least fourth (P2) year of pharmacy program
Desired Knowledge, Skills, and Qualifications
Experience with Microsoft office preferred

123

Medical Affairs Senior Project Analyst Resume Examples & Samples

Supports Medical Affairs market access and strategy across the various ET business and product lines
Facilitate cross-functional strategic planning and organizational engagement to drive market access for various ET product lines
Maintain a clear roadmap with specific timelines and activities for workstreams/projects
Facilitate cross functional/regional workstreams from a project management capacity
Communicate the status of workstream/projects to relevant stakeholders
Document best practices and lessons learned as required and appropriate
Facilitate process improvement initiatives across ET MA using industry and Medtronic best practices
Leadership:as a member of the ET Medical Affairs team, the role requires an effective facilitator and driver of results. The role will require significant interaction with stakeholders throughout the organization and influencing skills
Strategic Insight:The role will require support for implementation and execution of market access strategies that are aligned with overall ET strategies. This role will also be a critical voice and facilitator for market access strategies and ensuring alignment across the organization
Project management:The role will require successful deployment of project management capabilities to identify and execute short, mid, long term activities to drive successful execution of projects. This role will also serve to drive best practices and share lessons learned across the multiple ET MA
Communication:The role will support communication of projects and workstreams to ensure alignment, awareness, and management escalation
Office location: Early Technologies site
BS/BA in science or engineering/MBA or MS preferred
Minimum 2 years relevant experience in Medical Affairs (e.g. medical science, clinical affairs, regulatory affairs, heath care economics) and/or project management
Ability to influence others
Proven ability to support/or co-lead multiple high-impact process improvement projects
Computer proficiency with Excel, Word, Power Point, Project
Experience with analytical tools and dashboard generation

124

VP, Medical Affairs Resume Examples & Samples

Provides leadership to management within areas of responsibility
Oversees the development and continuous improvement of services, policies, processes, and programs, including medical practice review, governance, credentialing, privileging, peer review, medical information systems, and telemedicine opportunities
Formulates and implements operational strategies and initiatives, including patient safety, performance improvement and physician recruitment
Oversees operations, budget, financial targets, and human resources management
Assists in evaluating new business opportunities by actively engaging in strategic planning for business plan development
Monitors market trends, market share data and physician practices to look for opportunities for business growth
Implements new clinical initiatives and business plans as directed as the executive lead
Directs and oversees process for counseling and managing issues of physician professional conduct
Ensures adherence and completion of medical staff decisions regarding peer review and physician behavioral issues Leads the development of continuing medical education (CME), and other relevant education programs for medical staff
Provides consultative support to graduate and under-graduate medical education programs as applicable
Facilitates GME activities on hospital campus b ensuring hospital compliance and readiness for Clinical Learning Environment Review (CLER) visits by the ACGME
Works collaboratively with other staff to provide necessary clinical support services to facilities and medical staff. Assumes administrative leadership as mutually agreed
Ensures licensing and other governmental and regulatory requirements
Participates in surveys and inspections by accrediting/licensure bodies
Assists in investigating complaints, incidents, claims of malpractice and/or negligence on the art of hospital personnel and medical staff
Monitors major issues and trends in the practice of medicine and area of health policy advising medical staff and executive leadership in relation to organization activities
Serves as an advocate, intermediary and facilitator with external regulators for regulatory matters
Facilitates system training and implementation for physicians and assists in development of training modules and other EMR features
Facilitates development, training and implementation of High Reliability Organization principles for physician activities

125

Associate Director of Medical Affairs Resume Examples & Samples

Operational quality – maximize efficiency, patient access and patient satisfaction at all ambulatory and inpatient oncology sites. Serve as Chair of Hospital Cancer Committee and work with physicians and the tumor registry to achieve satisfaction of existing standards and benchmarks. Serve as a member of the ambulatory Clinical Safety Committee and as clinical director of the Cancer Nurse Navigators
Physicians – encourage and monitor adherence to evidence-based care guidelines, develop and monitor implementation of clinical pathways. Promote and advance patient centered cancer care as measured by patient satisfaction metrics in both the inpatient and ambulatory environments
Disease specific – among subspecialized practices within cancer care, ensure coordination across UF Health sites, leading to a uniform standard of care and best practice based on the highest quality metrics available. Facilitate disease specific integration of physicians practicing at different sites and provide recommendations regarding disease specific resource allocation across different sites in order to maximize the patient experience and enhance quality patient care. Chair the Cancer ICAP consisting of the various Disease Specific Group Leaders, Hospital and College of Medicine financial professionals, and others, as you deem necessary
Business Development – Work with marketing, business development and UF Health physicians to establish community relationships and increase the number of patients coming to UF Health cancer programs. Increase the UF Health market share for lung, GI, prostate and breast cancers in our local/regional market and for all cancers from the remainder of Florida
Research - Work with the leadership of the UF Health Cancer Center to facilitate UFHCC's clinical cancer research through the UFHCC clinical trials office and UF Clinical Translational Science Institute, supporting enhancement of clinical and translational research by incorporation of clinical research into our clinical practices
Experienced cancer physician with an active clinical practice
Associate professor or higher
Demonstrated interest and activity at a national and local level in Cancer quality and/or Policy

126

Head of Medical Affairs Resume Examples & Samples

Provide Leadership, line management and development of the CO medical staff. Ensure appropriate resourcing, skills and capabilities are in place to support CO, regional and global medical affairs activities, global research and development activities, and business support
Responsible for recruiting, retaining, and mentoring high potential associates
Plan and manage budget and headcount resources for the CO medical department, in full collaboration and transparency with the commercial/finance and HR team, and in consultation with the Regional Medical Affairs Head. 4.Set and execute Medical Affairs strategies for the CO in consultation with both the Regional Medical Affairs Head and commercial teams to ensure alignment with region and global strategic plans. Provide strategic input to the CO commercial plans
Development of local clinical research plans where appropriate. Conduct of local research activities in a scientific, efficient and compliant way, with due regard to applicable policies, processes and procedures and national regulations, and alignment with areas of strategic research interest for relevant products/therapeutic areas
Ensure that the CO operates an effective promotional material review & approval process, and act as final medical signatory (may be delegated) for all promotional and scientific materials / activities within the local organization. Act as final medical signatory (may be delegated) on all other relevant documents such as label changes, ensuring compatibility of materials with the local label
Establish medical and scientific information service for Sandoz products and products in development, and ensure that medical information is of high quality and communicated in an accurate, balanced, timely and compliant way. 8.Provide medical support for, and help develop and maintain professional and credible relationships with external experts and academic centers. Identify appropriately qualified external local experts who would wish to engage in collaborative efforts – such as potential research collaborations – with Sandoz; ensure a high level of scientific integrity in these collaborative efforts
Be a strategic collaborator in relevant commercial teams, and ensure medical alignment with local objectives where possible

127

Werkstudent Medical Affairs Resume Examples & Samples

Strong identification with the values of Celgene
Enrolled student in the natural sciences, business administration or similar
Interest in the German pharmaceutical market
Interest and understanding of advertising
Fluency in German and English
Good to excellent Excel and PowerPoint skills
Precise way of working

128

VP, Medical Affairs Resume Examples & Samples

In accord with the overall financial planning process and guidelines of WFH, ensures the preparation of budgets
Reviews periodic financial statements and reports, and makes changes in resource allocation, spending, and other relevant business activity, to ensure the financial viability and budget compliance of WFH
Supports and adheres to the financial controls and related policies and procedures of WFH, and ensures that administrative and business activities are conducted in support of operational excellence
A demonstrated track record of seven to nine (7-9) years in strategic and operational roles at progressively more responsible management levels required. Extensive experience in clinical operations, resource management and customer service excellence required

129

VP, Medical Affairs Resume Examples & Samples

Serves as a key member of SPS’ Executive Leadership Team, providing strategic direction related to the development and expansion of clinical services
Provides clinical leadership oversight of the Medical Management program and services within the Patient Service Center (PSC), Sutter Select and Sutter Health Plan (SHP), ensuring provision of high quality client and patient response, service and care
Oversees SPS’ Wellness Program, providing key clinical expertise and working with 3rd party vendors
Serves as a leader in best practice and optimization of Sutter Community Connect (SCC) as a clinical tool
Provides clinical quality oversight, governance and strategic direction for the PSC clinical programs, and assist with risk management processes and sentinel events
Oversees the clinical advice line team activities, including PSC risk management and sentinel events procedures
Champions, supports and influences the adoption of automation and web-based tools at physician practices to enhance clinical practice and outcomes
Works closely with the Sutter Community Connect leadership team to provide clinical decision support and policy, support strategic initiatives, and maintain excellent relationships with Sutter Community Connect clients
Progressively responsible medical/clinical management experience, typically obtained during 5-7 years; preferably in a large complex health care institution. Health care institution experience may be substituted by active medical practice experience with formal training or experience in electronic medical record systems and implementations, and clinical informatics
Previous experience as a Chief Medical Executive; Medical Affairs, a plus
At least 2+ plus years of experience working with electronic medical record system, preferably EPIC
Demonstrated success at improving the efficiency and effectiveness of large groups of physicians in significant capitated markets
Prior experience in monitoring and evaluating quality of medical care and development of disease management programs
Experience in establishing and managing service level agreements, and monitoring delivery of services

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