Director, Medical Affairs Resume Samples

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E Tremblay

Elise

Tremblay

3998 Auer Square

Phoenix

+1 (555) 604 6157

3998 Auer Square

Phoenix

Phone

p +1 (555) 604 6157

Experience Experience

Chicago, IL

Director Medical Affairs

Chicago, IL

Boyer and Sons

Chicago, IL

Director Medical Affairs

Planning, designing and managing global and overseeing regional/local medical Advisory Boards
Proven track record developing, presenting and publishing clinical studies
Conducting medical review and approval of promotional and meeting materials
Providing physician leadership for scientific communications, including standard responses and publications
Providing medical review of Investigator Initiated Research (IIR) proposals and other grants through the grant approval process
Reviews continuing education and unrestricted grants as well as investigator-sponsored studies proposals
May participate in the evaluation of potential in-licensing candidates

Chicago, IL

Director, Medical Affairs

Chicago, IL

Mohr Inc

Chicago, IL

Director, Medical Affairs

Assist in SOP development related to Medical Affairs, including training on SOPs (IITs, RML work, clinical trial work, etc)
Works with relevant functions to support validation efforts to provide consistent data collections, review and create protocols
Develops and manages a thought leader network to support the successful execution of Tysabri Medical Affairs tactics
Provide expertise and coordinate Med Affairs operational support of ozanimod and anti –IL-13 phase 3b/4 development plan
Work to establish ourselves in clinical guidelines
Provide medical support to the medical affairs organizations including developing and delivering training curriculum and content
Provides guidance, mentorship and management to the Associate Director, Tysabri

present

New York, NY

Associate Director Medical Affairs

New York, NY

Boehm LLC

present

New York, NY

Associate Director Medical Affairs

present

Manage the disease area Medical Science Liaison team, including managing definition and implementation of field activity plans
Lead planning, execution and reporting of key medical projects (e.g., Advisory Boards, communication events, Satellite Symposia, etc.)
Support Country Medical Director in defining and leading local medical initiatives and KOL plans
Develop expertise in all medical areas relevant to designated CSL Behring products including analysis of current literature, opinion and recommendations
Serve as Shire presence at external meetings including scientific symposia and cooperative group meetings
Has regular information meetings with cross-functional counterparts in Marketing, Sales and Market access
Ensuring local legislation is followed for all medical activities in each Nordic country

Education Education

Bachelor’s Degree in Confidentiality

Kean University

Bachelor’s Degree in Confidentiality

Skills Skills

Demonstrated ability to make good decisions regarding the resolution of complex regional or functional problems, regardless of popularity of decision
Ability to develop an operating budget to monitor expenditures and project deliverables; manages variances between budgeted and actual expenditures
Proficiency in project management and in negotiating project budgets
Ability to set and monitor program objectives that are aligned with the global DHR LSDx segment
Comfortable with ambiguity
Ability to create strategic global evidence generation strategy and communicate to leadership
Able to guide project teams in multiple technical areas (programming, modeling, literature analysis, etc.)
Ability to follow FDA regulations, ICH guidelines, and GCPs governing the conduct of clinical research
Professional maturity and confidence in expressing a point of view with senior management
Ability to work in a matrix, multidisciplinary organization

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15 Director, Medical Affairs resume templates

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Director Medical Affairs Resume Examples & Samples

This position requires a medical degree (or equivalent)
Board certification in Dermatology is preferred
A minimum of 5 years of medical affairs and clinical research in industry, academia or as a clinician is required
Must have a broad understanding of GCP and regulatory requirements
Must have excellent oral and written communication and presentation skills
Must be dynamic and have the ability to work in a matrix environment with cross functional teams
This position may require up to 20% annual travel (domestic and international)

Senior Scientific Director, Medical Affairs Resume Examples & Samples

Participation 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. Oversees the conduct of clinical trials and is medically and scientifically accountable for resolution of safety (AE’s & SAE’s) issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities
Serves as the scientific team interface for key regulatory discussions

Associate Director, Medical Affairs Resume Examples & Samples

Reporting to the Sr. Medical Director of Emerging Brands, work closely with the Medical Directors of assigned disease states to execute the Medical Strategy, including review of clinical and scientific content
Activities will include providing subject matter expertise in the development and review of medical, promotional and training materials
Content review for materials produced by the Medical Affairs department (slides, white papers, publications)
Develop and organize basic training of Avanir's therapeutic areas for non-commercial, non-scientist home office personnel
Assist medical directors in execution of data generation projects, including focused analysis of existing datasets and medical-team generated clinical research
Complete all responsibilities in accordance with organizational and industry standards for compliance, regulatory and ethical practices

Associate Director, Medical Affairs Eumea Resume Examples & Samples

Serve as the medical and technical resource for answering scientific and medical questions and enquiries by internal and external collaborators, investigators, consultants and contract resources
Management of BioMarin Independent Research Program in the region in collaboration with the Global and the EUMEA regional medical teams
Support of generation of scientific publications
When required, act as the medical monitor for BioMarin clinical registries
Collaboration with the Marketing department to ensure appropriate medical and scientific content of the programmes
Medical review of promotional material to ensure adherence to the company’s high ethical standards and relevant Codes of Practice
Support Market Access department by assisting the compilation of the clinical section in the company pricing and reimbursement approval documents
Present at advisory boards, investigator and other scientific meetings and ensure the highest level of scientific content
Present at training courses, sales conferences, regional meetings, etc to develop high level of medical knowledge within sales force
Review of new study protocols ensuring feasibility within the regional environment
Support clinical research group in identification and collaboration of the study sites
Industry experience in a similar role is essential, preferentially in orphan diseases
Proficiency in the ABPI Code of Practice is required
Outstanding presentation, written and oral skills are required

Director, Medical Affairs France Resume Examples & Samples

The position holder is the key BioMarin Medical Affairs representative for both external and internal customers from the respective region (France, BeNeLux, Nordics, Switzerland)
Responsible for development and implementation of the regional MAF strategy in alignment with EUMEA and Global Medical Affairs
Review of draft IR protocols, reports and manuscripts as well as management of regional IR processes
Support regional clinical registries and promotional activities for BioMarin products in accordance with respected regulatory requirements
Help identify publication opportunities from the region. Promote effective communication between internal and external groups regarding Medical Affairs initiatives
Interact with relevant thought leaders, scientists and strategic partners within the region
Present at training courses, sales conferences, regional and international meetings, etc. to develop high level of medical knowledge within the region
Attendance at local and regional congresses and scientific meetings
Continuous training on relevant local laws and regulations
Very strong industry experience, preferentially in orphan diseases
Demonstrate excellent medical affairs skills and ideally have working knowledge in the therapy area

Director, Medical Affairs Resume Examples & Samples

Provides expert opinion on the current trends in the pathophysiology, diagnosis, existing and emerging treatment options as well as unmet medical needs in the therapeutic area to inform key medical and business decisions
Build mutually valuable partnerships within the medical community through the execution of the US Medical Affairs program
Develop strong relationships with key opinion leaders, key professional societies and organizations in collaboration with regional medical affairs and clinical colleagues through scientific dialogue pertinent to Celgene I&I interest
Participate in and support clinical and medical affairs strategies in conjunction with commercial counterparts. Provide ongoing and interactive technical and medical expertise to execute on these strategies
Provide medical support to the medical affairs organizations including developing and delivering training curriculum and content
Primary focus in IBD will initially be on ozanimod ; may later expand to include mongersen and apremilast
Support design of phase II studies in eosinophilic
Provide expertise and coordinate Med Affairs operational support of ozanimod and anti –IL-13 phase 3b/4 development plan
Support Publication Team in timely preparation of abstracts and manuscripts on ozanimod in GI
Participate in scientific review of submitted Investigator Initiated Trials and related medical affairs activities (e.g. registry/database projects, epidemiological surveys etc.)
Participate in advisory meetings with opinion leaders
Actively participate on promotional review committees to ensure content is medically appropriate and compliant with internal and external requirements
Assist in the development and delivery of appropriate scientific information and education to key customers in cooperation with local operating unit
Assist in providing direct research and educational support (clinical trials, KOLs, Ad Boards) in as needed
Work with existing leads in the development of KOL mapping and HEOR strategies
Assist in SOP development related to Medical Affairs, including training on SOPs (IITs, RML work, clinical trial work, etc)
Assist in organizing Advisory Boards, Registry meetings, or other meetings as needed
Develop a 3 –year Congress and Publications Plan for ozanimod in IBD
Review external proposals for CME support as assigned
Provide support to Medical Information in eth development of ozanimond GI Medical Information letters
M.D., D.O., PhD or Pharm D or equivalent degree and/or experience, preferable with experience in the areas of Gastroenterology
Minimum 10 years of experience in the therapeutic area, preferably in the biotech or pharmaceutical industry or similar academic institution, is required
Strong scientific analytical skills
Basic knowledge and appropriate application of biostatistics; proficiency using standard software suites
Proficient in Microsoft Office applications including power point and outlook

Senior Director, Medical Affairs Hem-onc Resume Examples & Samples

Ability to assess, understand and communicate continuously expanding medical and scientific information, as well as market knowledge
Anticipates future industry trends and opportunities, and proactively develops plans to address through HEM/ONC MA strategy
Excellent analytical skills, demonstrated ability to identify and understand complex issues and problems and identify key findings from study data and publications
Ability to suggest solutions for issues encountered with clinical studies and other projects in area of responsibility
Proficiency in MS Word, PowerPoint, Excel, and Outlook
Organized, able to meet timelines in fast-paced environment with strong attention to detail
MD with a background in Hepatitis
5+ years experience in Medical Affairs and/or Clinical Research including Phase IIIb and IV studies; clinical trials management, medical monitoring and scientific expertise
Documented track record in Medical Affairs
Including: study design, management and conduct, study evaluation, medical writing skills, expert panel conduct, symposium and workshop management, KOL management
Specific experience in HEM/ONC
Experience in clinical patient care role
Finance and budgeting experience

Senior Director, Medical Affairs Resume Examples & Samples

Provide medical expertise to cross-functional teams
Represent the voice of the patient, clinician and other healthcare providers to product development teams
Provide input in identification of customer product and educational needs
Develop and manage relationships with KOLs and medical societies as needed
Lead content development for advisory board meetings and other medical education initiatives
Present data at medical advisory board meetings and medical trainings
Participate in Medical Information activities, ensuring communications with customers are adequate and supported by adequate data
Participate in medical publication and communication activities
Review and provide comments/feedback on advertising and promotional materials
3-5+ years clinical practice experience as Obstetrician, Reproductive Endocrinologist, or Medical Geneticist
5+ years in industry setting; previous experience in Medical Affairs preferred
Strong theoretical and practical understanding of reproductive medicine and genetics
Understanding of product use and rationale in clinical setting (prenatal aneuploidy testing, preimplantation genetic screening/diagnosis, genetic carrier screening)
Able to delegate/facilitate projects
Ability to solve problems, prioritize and multitask
Strong work organization abilities and standards
Managerial experience a plus
Travel required approximately 25-30%, primarily domestic with some international
This role could be located in either our San Diego Headquarters or in our San Francisco Mission Bay office. Relocation assistance will be provided

Senior Director, Medical Affairs Resume Examples & Samples

Develops and executes medical strategy for a core therapeutic franchise; provides overall scientific and medical oversight within the therapeutic area for marketed and pipeline products
Responsible for the review and approval of product claims, promotional material and regulatory documents, in compliance with corporate standards government/industry regulations, ensuring that information is scientifically accurate and medically appropriate
Medical Degree (MD) or another advanced degree, e.g., Pharm D or PhD and 8+ years pharmaceutical or related industry experience in Medical Affairs in the relevant therapeutic area. A proven track record of contribution to commercial, medical and/or clinical development strategies is preferred. However, a combination of experience and/or education will be taken into consideration
Board eligible or certification in therapeutic area related to the position and clinical research experience
Infectious disease, ARV/HIV experience is preferred
Ability to read and interpret comprehensive and intricate research documents. Ability to write scientific reports and technical correspondence. Ability to work with executives and communicate abstract concepts. Ability to present to a high level of the organization and groups outside of the organization
Ability to research and critically analyze product information, clinical data, and the medical literature
Proven ability to effectively communicate information at management level, with public groups and to scientific leaders. Proven ability to translate complex science into clinically relevant information. Excellent interpersonal, analytical, communication (written as well as oral), results oriented project management, facilitation and consultative skills to influence decision making

Analytics Director Medical Affairs Resume Examples & Samples

Build and manage the analytics function for DCV Medical Affairs, supporting US and Regional Field Based Medical teams, building processes and managing the analytics objectives; contributing overall to the following
Proficient in Microsoft Excel, Qlikview and other common analytic tools, especially data collection and visualization techniques that can be readily updated frequently as well as ad hoc
Demonstrated strong client-orientation when working with and for internal customers
Demonstrated comfort in interacting with senior management
Demonstrated curiosity to tackle hard business problems using data and analytics to develop meaningful, practical solutions
Previous experience working with field medical and or medical information functions preferred
Previous demonstration of abilities to create “dashboards” to summarize analytic trends requiring synthesis of several disparate sources of data into a common view strongly preferred
O Proficiency in accessing data sources of differing complexities required. Knowledge of analytic techniques including practical statistics and knowledge of database querying and query design a plus

Associate Director, Medical Affairs Resume Examples & Samples

Provide Medical Affairs support to the commercial organization for all initiatives including those related to the review and approval of promotional materials
Design and execute post hoc analyses of company scientific data
Propose, design and participate in execution of Phase IV studies as per approved medical plan
Participate at scientific meetings presenting results, attending pre-defined sessions to address specific company interests
Contribute to the training of internal Sunovion personnel as well as sales force in close cooperation with Sales Training
Act as conduit for independent research proposals (IITs –Investigator Initiated Studies) and grant requests (educational activities)
Provide support to the non-commercial departments of Sunovion, which include but are not limited to Clinical Research, Health Economics / Outcomes Research, and Scientific Communications
In cooperative effort between therapeutic disciplines (CNS/ respiratory) and with direct input from Medical Affairs therapeutic area leadership, enhance the unique value and targeted contribution of the position of Associate Director, Medical Affairs within the Medical Affairs Department
Liaise with KOLs (regarding study proposals or related initiatives; function as interface) along with other members of the therapeutic area teams
Provide Medical Affairs support to Business Development
Degree in Health Sciences, advanced degree (PharmD, PhD, MD) strongly preferred
Meaningful experience (3+ years) in Medical Affairs or as a Medical Liaison (5+ years) with Epilepsy / Neurology as a therapeutic area of focus
Solid scientific expertise
Good interpersonal skills as well as excellent written, oral communication and presentation skills required

Senior Director Medical Affairs Resume Examples & Samples

MD degree required; medical oncology specialty training preferred
Strong clinical/medical background (training and/or experience) with ability to successfully communicate and teach in a complex and competitive environment
12 + years of experience in medical affairs or medical practice is preferred; will consider highly qualified candidates with lesser experience
Strong interpersonal, organizational and communication skills both written and oral
Public speaking ability and facility required
Ability to prioritize and drive to results with a high emphasis on quality
Demonstrated team player

Associate Director, Medical Affairs, Oncology Resume Examples & Samples

Provide day-to-day clinical and medical guidance while working closely on joint projects with other members of the Medical Affairs team and other departments within Jazz; projects may include scientific congress/conference strategy and planning, advisory boards, publications, field force training, review of medical information standard response letters, health economics and epidemiology analyses, and marketing/policy related projects
Participate in appropriate cross-functional and cross-company Clinical and Commercial teams to inform brand strategies and tactics and represent Medical Affairs
Consistently demonstrate a positive, collaborative attitude that exemplifies ownership of business, teamwork with peers, and respect of supervisors, peers and customers
Advanced degree required (PharmD, MD, PhD) with Hematology or Oncology training or experience preferred
A minimum of 5 years in medical affairs or similar roles within a pharmacological company or equivalent clinical tenure in hematology/oncology
Demonstrated ability to build credible professional relations with Key Opinion Leaders
Ability to deliver scientific presentations

Director, Medical Affairs Operations Resume Examples & Samples

Maintain a competitive organizational structure and supervise departmental recruitment initiatives to guarantee optimal resourcing for execution of medical initiatives
Direct the annual strategic planning process to ensure medical projects are aligned with company priorities and resource allocation reflects the relative importance of therapeutic areas and products. Maintain alignment between medical and commercial functions in a way that achieves collective goals and respects/maintains compliance with corporate policies and regulations
Ensure departmental contracts and purchase orders are compliantly executed, a system for tracking of project milestones is established and maintained, and the departmental budget is tracked
Collect and communicate performance measures for Global Medical Affairs across all functional and therapeutic areas. Monitor performance measures and take appropriate actions when necessary
Design and oversee the execution of scheduled and ad hoc Global Medical Affairs reports to aid Senior Management in strategic decision-making
Develop, implement, and maintain policies and procedures to facilitate and improve efficiency and ensure compliance across the Global Medical Affairs organization. Proactively monitor systems and processes to ensure compliance with company and industry standards. Identify and recommend solutions to problems and/or issues with personnel and/or processes across the department
Provide therapeutic knowledge or expertise on business development projects and manage Global Medical Affairs integration process after deal completion
Develop and manage a first-in-class global medical training program; Utilize global company resources, including Global Training Managers to successfully execute the global medical training program
Monitor and manage the administration of Field Medical Affairs systems (customer relationship management (CRM) software, training portal)
Directly supervise the grants management processes, practices, and systems by strategically overseeing all program related administrative functions and personnel
Provide leadership and oversight for Late Phase Research initiatives and investigator initiated research projects
Manage the overall performance of Global Medical Affairs Operations personnel
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments
Perform other related duties and responsibilities, as assigned
Ability to work in a fast-paced, dynamic environment; works well under pressure
Applied knowledge of project management tools and processes (e.g. management of integration, scope, time, cost, quality, human resources, communications, risk, and procurement)
Experience with developing and measuring performance outcomes (e.g. metrics, dashboards)

Director, Medical Affairs Resume Examples & Samples

Develop Medical Affairs Strategy in alignment with Clinical, Commercial and Senior Management. Develop consensus around the strategy, implement strategy, and report on successful outcomes
Ensure successful, compliant implementation of Educational Grant, Corporate Donation and Investigator Initiated Study Programs, in alignment with Corporate Strategy
Develop comprehensive knowledge of disease state and product data. Use this knowledge to serve as product and disease state expert for the development of Medical Affairs, Commercial and Corporate materials, Advisory Board presentations, Health Outcomes needs, Clinical Study designs, publication plan, MSL strategy, etc.
Development of peer relationships with National EEs
Lead development and execution of a cross-functionally aligned strategic publication plan
Advise business development on in-licensing, and out-licensing opportunities
Ensure timely, accurate compliant communication of Medical Information responses to unsolicited requests, including development of responses and communication of metrics regarding requests
Effectively represent Vanda Medical Affairs to external clients and vendors, with scientific credibility and effective negotiation skills (e.g., Medical Societies, Patient Groups, CME Vendors, PDR, etc...)
PharmD, PhD, MD, or similar terminal degree
5 years of relevant Medical Affairs experience in the pharmaceutical industry
Excellent oral and written communication skills, strong leadership skills, self-motivated, team-player
Adaptability to a dynamic environment
Sophisticated understanding of Business and Marketing Strategies in the Healthcare Sector
Familiarity with the drug development and commercialization process
Knowledge of FDA regulations, OIG guidance, ICH guidelines and Good Publication Practices

Associate Director Medical Affairs Resume Examples & Samples

Manage the disease area Medical Science Liaison team, including managing definition and implementation of field activity plans
Oversee and directly participate in responding effectively to requests for scientific exchange
As delegated by the Country Medical Director, serve and the Medical representative on cross-functional local and Global teams
Support local team disease area and product knowledge through scientific training
Define key performance indicators and metrics to track progress against the activity plan
Maintain awareness of and access to internal and external information sources available to support best-in-class scientific exchange, and coordinate high-quality interactions between these resources and external customers
Manage the disease area Medical Science Liaison team,
Work with Country Medical Director to secure required tools and resources for MSL effectiveness
Oversee and participate in responding effectively to requests for scientific exchange
Coordinate response within defined timeline and quality standards to unsolicited inquiries from HCPs and other stakeholders received by Global Medical Affairs and referred to GMA by other Shire functions
Maintain personal and medical team expertise in relevant disease areas and Medical Affairs and Medical Research best practices
Maintain knowledge base and scientific expertise on all assigned Shire disease areas and product
A medical degree (MD) is desirable; PhD or degree in life sciences is preferred
Able to identify and develop target competencies (integrity, openness, competence, consistency, loyalty) in one’s self and the team
Good people management skills with demonstrated ability to set goals and object

Director, Medical Affairs Resume Examples & Samples

Collaborate with key MMS business leaders to determine and track regional unmet EG needs through involvement in BD product development, value assessments, and evidence gap assessments
Design and implement research projects outlined in the annual evidence generation plan, including but not limited to: workflow / efficiency studies, patient outcomes studies, retrospective data analyses, and prospective clinical studies
Develop study synopses, study protocols, analysis plans, study reports, advisory board presentations, manuscripts, abstracts, posters, and podium presentations
Provide direction and supervision for the Evidence Generation staff which currently includes 2 analyst positions to accomplish these responsibilities
Provide project management and guide internal CoE resources / external vendors to execute strategies
Represent global EG department on internal working teams and with external agencies (as needed)
Provide consultative expertise in support of early and late stage clinical development and business development activities
Partner with MMS HEOR functional lead to guide the collection and publication of health economic data across priority programs across product life cycle
Interact with external thought-leaders to conduct research, develop advocates and/or provide evidence dossiers to support product access and adoption
Triage general evidence generation requests to appropriate expertise and resourcing
Minimum of Bachelors’ degree required, Advanced degree (Pharm. D., MSc or MPH) is highly desired. Relevant disciplines may include Medicine, Pharmacy, Health Services Research, Economics, Epidemiology, Public Health and Healthcare Policy
10+ years of relevant industry experience
8+ years of experience in evidence generation / clinical trial operations
4+ years of supervisory experience with demonstrated ability to mentor and develop individual contributor
Ability to create strategic global evidence generation strategy and communicate to leadership
Understanding of evidence generation work concepts, principles and practices with significant experience executing priority programs with moderate to high complexity and visibility
Expert research and analysis skills required including; literature reviews, secondary data analysis methods, manuscript writing and excel spreadsheet models
Understanding of economic stakeholder hurdles across key businesses and regions; experience with regional support for evidence generation
Collaborative and works well in a cross-functional, multi-cultural environment
Proficiency in project management and in negotiating project budgets
Able to guide project teams in multiple technical areas (programming, modeling, literature analysis, etc.)
Ability to follow FDA regulations, ICH guidelines, and GCPs governing the conduct of clinical research
Ability to develop an operating budget to monitor expenditures and project deliverables; manages variances between budgeted and actual expenditures

Associate Director, Medical Affairs Oncology Resume Examples & Samples

Develops, reviews and follows up on clinical studies and medical projects initiated within the relevant therapeutic area (e.g. post marketing clinical activities such as registry/database projects, epidemiological surveys, post-authorization studies (phase IV), IIS projects, etc.) at the regional/local level. 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
Participation in design and execution of clinical trial safety, product safety and risk management plans. Responsible 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
May assist as consultant/liaison with other corporations when working under licensing agreements and/or in the evaluation of new business development opportunities
Responsible for understanding the regulatory requirements related to the clinical studies and accountable for complying with those requirements
May assist in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia
May assist with the scientific review, development, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities
Exercises judgment within well-defined practices and policies. Typically does not supervise employees but must be able to influence in a matrixed environment. Works with some supervision and guidance

Director, Medical Affairs, Oncology Resume Examples & Samples

Lead a matrix medical affairs team comprising of Medical Science Liaisons (MSLs), Medical Communications, HEOR, and Medical Information in the development of a scientific platform and a medical strategic plan - both complementing the commercial plans for any product assigned to her/him
As a subject matter expert provide day-to-day clinical and medical guidance while working closely on joint projects with other members of the Medical Affairs team and other departments within Jazz; projects may include scientific congress/conference strategy and planning, advisory boards, publications, field force training, review of medical information standard response letters, health economics and epidemiology analyses, and marketing/policy related projects
Provide scientific input into publication strategy and review manuscripts for publication and abstracts and posters for presentation at scientific meetings
Participate in the Investigator Initiated Research review and educational grant process
Provide clinical and scientific support in responding to inquiries from healthcare professionals and managed care organizations
Ensure that all medical affairs presentations are consistent, accurate, and clinically meaningful
Assist with review and approval of promotional materials
Advanced degree required (PharmD, MD, PhD, or equivalent) with Hematology or Oncology training or experience preferred
A minimum of 10 years in medical affairs or similar roles within a pharmacological company or equivalent clinical tenure in hematology/oncology
Excellent verbal & written communication skills as well as interpersonal skills
Proven ability to collaborate with internal colleagues in sales, marketing, and managed care
Proven successful management of teams either directly or in a matrix environment
Self-starter with positive can-do attitude

Director, Medical Affairs Turkey Resume Examples & Samples

The position holder is the key BioMarin Medical Affairs representative for both external and internal customers from the respective region
Responsible for the development of a regional Medical Affairs Plan for appropriate products and/or therapeutic areas
Medical input and support in the implementation of international documents within the region
Clinical trial and publication experience is preferred
Knowledgeable in Turkish pharmaceutical regulations
Knowledgeable in current GCP guidelines in Europe
Ability to work proactively and effectively, with exceptional creative problem solving skills
Willingness to travel approx. 50% (also international) Travel within the EUMEA region and to the U.S. will be expected

Temporary Director, Medical Affairs Resume Examples & Samples

Advanced degree (eg, PhD, PharmD, MD) in a medical or scientific discipline
At least 2 years experience performing medical reviews as part of a legal-medical-regulatory review process in support of a prescription drug franchise
Knowledgeable of the legal and regulatory framework applicable to pharmaceutical communications to patients and prescribing physicians
Excellent interpersonal skills with demonstrated ability to function well in a collaborative, matrix, team-based environment and the ability to constructively manage input
Demonstrable skills making complex scientific topics simple and accessible to multiple audiences
Background experience in Cystic Fibrosis or other pulmonary disease
Strong sense of responsibility and urgency, with the desire to work independently in diverse teams involving multi-functional disciplines, take ownership of projects, be flexible, and manage simultaneous priorities under changing deadlines

Regional Director Medical Affairs Resume Examples & Samples

MD, PhD or PharmD and recognized expertise through at least 5 years of clinical and/or research experience (incl. publications) in fertility is required
At least 4 years of pharmaceutical (or related) industry experience in country with proven track record of contribution to medical, clinical or commercial strategies is desired
Strategic thinking, specifically related to the development of Medical Affairs goals and strategies that address asset value proposition, and clinical and value evidence
Customer expertise especially scientific leadership and other key stakeholders (public groups, government officials, medical professional organizations) in therapy areas
Demonstrated ability to effectively influence company decisions
Excellent interpersonal, analytical, and results-oriented project management skills
Strong prioritization skills and ability to understand how decisions fit into the broader context of corporate strategies
In a matrix environment, able to effectively collaborate across divisions
Fluency in English and excellent communication skills, both oral and written

Associate Director, Medical Affairs Ahus Resume Examples & Samples

Develop and maintain the highest scientific and medical expertise in aHUS and be acknowledged internally and externally as an expert in this area
Develop and implement the Country Medical Plan aHUS aligned with the overall corporate strategic objectives and the Global Medical Plan
Maintain a high level of knowledge of current local pharmaceutical regulations and ensure their implementation in conjunction with the Associate Director, Local Regulatory Affairs Leader
Maintain a high level of knowledge of Alexion policies and procedures, including those related to promotional materials and activities and educational programs and ensure their implementation in conjunction with the Associate Director, Local Regulatory Affairs Leader
Drive the identification, development, management of Key Opinion Leaders
Identify and implement high-impact medical research projects and support the implementation of Alexion sponsored and investigator initiated studies
Manage requests for Alexion product supply for compassionate use cases, in accordance with local laws and regulations and with Alexion procedures
Provide insights for the development, review and approval of presentation materials for scientific meetings, symposia and other field Medical Education activities
Support the Global Pharmacovigilance Dept. to ensure that pharmacovigilance requirements are fulfilled according to regulatory and company policy
Background / experience in nephrology a definite plus
Demonstrated ability to influence important customers, challenge common perceptions and implement medical affairs tools to improve patient care and outcomes
Demonstrated ability to accurately and effectively evaluate medical/scientific literature and develop effective medical strategies and communication strategies
Experience of early and late clinical development
Experience of Pharmacovigilance
Experience in leading teams and managing people
Computer literate with MS PPT and Word software as well as CRM software
Adaptability to multicultural environment

Director, Medical Affairs Resume Examples & Samples

Responsible for leading the strategic design and execution of the Tysabri medical plan and tactics
Responsible for guiding Phase 4 strategy and implementation, providing review of IIT/SRA proposals, data generation, providing key input into data analysis and publication, medical education and assisting with integration of varied medical brand initiatives
Maintains fiscal responsibility for the medical brand activities
Involvement with key HCPs in the exchange of scientific and medical information including Advisory Boards and presentations at national and international meetings
Develops and manages a thought leader network to support the successful execution of Tysabri Medical Affairs tactics
Provides guidance, mentorship and management to the Associate Director, Tysabri
MD, PhD, Pharm.D. With 5+ years of industry experience, preferably in neurology
Ability to anticipate and adapt to change while maintaining the momentum of an overall strategic plan
Ability to understand the evolving market access and reimbursement landscape and business needs of BIIB and how the strategies of US Medical Affairs fit into this
Strong background in ethical evaluation of clinical research projects, and proven ability to conduct medical and scientific analysis and decision-making

Director, Medical Affairs, Oncology Resume Examples & Samples

Provide clinical analysis and support for Janssen Biotech products for hematologic malignancies
Responsible for and support company sponsored MA led interventional and observational clinical trials, including overseeing medical and safety monitoring
Assess and supervise Investigator Initiated Studies
A minimum of three years of Medical Affairs and/or Clinical Research & Development experience in the pharmaceutical industry is required
Experience in clinical trial design and conduct (Phases II-IV), including medical monitoring of interventional oncology clinical trials is required
Position requires up to 25% annual travel (primarily domestic with some international travel)Medical Affairs

Director, Medical Affairs Resume Examples & Samples

12 Industry-based clinical and Medical Affair experience in a pharmaceutical or biotech setting
Practical knowledge of general medicine and drug therapy, including pharmacology, toxicology, trial methodology and clinical pharmacology, and an in depth knowledge and understanding of scientific principles for controlled trials, is essential
A high level of professionalism, and the ability and willingness to work effectively in a team setting
Knowledge of regulatory requirements for NDA submission and experience interacting with regulatory agencies will be beneficial
Ability to travel 30% to 40% of the time
Strong interpersonal skills with a proven background of interacting successfully with individuals at a variety of functional levels, both internally and externally

Director, Medical Affairs Resume Examples & Samples

To establish a network of credible consultative relationship with KOLs that will advise, lobby and participate in our market development and product management activities
To develop plans and faciliate key influencers to write white papers and generate publications in reputable journals to create awareness. This includes drafting and reviewing clinical protocols to advance our clinical interests
Work to establish ourselves in clinical guidelines
Presentations to hospital/medical staff and clinical laboratory staff to support current issues and enhancing value-added services
Assess and understand the medical and clinical environment in order to sustain and leverage expertise in relevant disease states and new treatments/tests, competitive products and implications for Thermo Fisher
Gather competitive information and communicate through appropriate venues and channels. Participate in business review and strategy meetings to address technical and clinical issues to drive adoption of our solutions
Develop, support and participate in product testing, disease state training of internal and external customer needs. This includes supporting to develop commercial tools and aids
Works with relevant functions to support validation efforts to provide consistent data collections, review and create protocols
Partners with businesses across the company to develop strategies for growth and effectively grow our partnership with customers to develop companion diagnositcs opportunities
Works closely with divisional leadership and key functional area stakeholders to drive execution of strategy and tactics to achieve business objectives
Analyzes industry dynamics and the competitive landscape and identifies opportunities for expansion in assigned key accounts and regions
MD or PhD in clinical pathology or biology, Board certified preferred
Minimum of 5 years’ experience as a Clinical Pathologist or other experience in clinical or medical affairs
Experienced in delivering presentations on clinical topics to global KOLs
Demonstrated ability to develop and maintain professional and personal relationships with key partners and customers positively advancing the organizational objectives
Excellent communication, team-building, and leadership skills
Demonstrated success working in a global, matrixed-environment with ability to influence without direct authority
Experience and demonstrated aptitude both managing and prioritizing multiple projects and initiatives

Associate Director, Medical Affairs Resume Examples & Samples

Support the MSL Director to ensure all external presentations are consistent with company standards
Creating & updating medical affairs -specific communication pieces and ensuring that disease state, product, and pipeline presentations are scientifically accurate, complete, not misleading, up-to-date, aligned to the communication platform and meet regulatory requirements
Review and approval of promotional and medical materials
Liaise with cross-functional project teams to execute data generation projects, including focused analysis of existing datasets, pharmacoeconomic and outcomes research projects, and medical-team generated clinical research
Serve as the medical expert to oversee execution of the publication plan, including manuscript development, review and quality assurance with the author team
Provide Medical review of IIS and grant proposals

Director, Medical Affairs Resume Examples & Samples

Management of Medical Information
Previous multi-year leadership experience in Medical Information mandatory, including creating response documents, identifying insights from medical information databases, and review of promotional materials for medical accuracy
Able to move between therapeutic areas with ease, including cosmetics, dermatology, neurology, GI, or OTC products
Experience with medical review in PRC/MLR
Must have excellent written and oral communication skills, possess strong analytical and interpersonal skills, ability to work independently
PharmD strongly desired or MD in health care field from an accredited college or university (may consider Master level candidates with the right experience)
Highly motivated self-starter with a positive attitude, possessing the initiative required to achieve desired goals both independently and within a team structure
Demonstrated project management ability
Strong relationship-building skills, particularly with the research community
Team-oriented, with the ability to work effectively with others

Senior Director, Medical Affairs Resume Examples & Samples

Provide strategic medical management of key OraPharma/ Dental therapeutic programs
Create and manage budget
Manage key line function (e.g., medical information)
Foster enduring relationships with top scientific key opinion leaders
Ensure rapid integration of new products and businesses into Medical Affairs, including staffing aspects
Ensure effective input for promotional review committees
Support R&D organization and act as medical monitor and medical expert for oral care/dental products studies
Authority to sign for the funding of grants, consulting agreements, as per policy limits
Senior Director title level is dependent on experience (e.g., Associate director through Executive levels)
Executive level requires managerial experience and the expectation that the role would require managing direct reports
Must have subsantial experience with dental and/or oral care products to include device
Leadership experience in Clinical/Medical Affairs, with fast paced and responsive style
Excellent management and organizational skills
Ability to interact easily with all levels within the organization; tactful; mature; flexible
High level of collaboration and influencing skills
Poised, knowledgeable scientific presenter with experience in presentations within pharma industry and in external venues such as medical congresses
Experience in creating strategically relevant materials for use by Medical Affairs and other relevant line functions
DDS, MD, PhD, or PharmD required
Minimum 5 years in pharmaceutical industry, in Medical Affairs and/or clinical trials/research
Experience in review/editing promotional materials
Follows all applicable policies and SOPs
Ability to travel for both internal and external meetings (up to 50%)
Key Relationships

Director, Medical Affairs Resume Examples & Samples

Scientific leadership: Overall responsibility for the development, prioritization and delivery of the Oncology Medical Affairs Plan (MAP) that addresses identified gaps
Interactions with Regional and Global Medical Affairs to advocate for support of Canadian initiatives at the regional/global level
Interactions with Global Clinical Trials Organization (GCTO) and MRL (Merck Research Laboratories) Organization in support of country portfolio of MRL studies and to continue to attract clinical development studies to Canada and MRL-Phase II-III trials, Local Clinical Evaluations and Investigator-initiated studies
Education: Minimum Ph.D., with a strong preference for an M.D. degree
Experience: 7-10 years of people management experience in Clinical Development and/or Medical Affairs (preferably in Oncology) is required
Experienced Medical Pharmaceutical Leader, with extensive knowledge of the pharmaceutical industry and the drug development process
Must possess a comprehensive clinical knowledge of Oncology as well as a keen understanding of strategic clinical development and principles of study design
Advanced negotiation, presentation and facilitation skills
Strong people management and team leadership skills, as well as listening and coaching skills
Strong ethics and integrity. Solid knowledge of GCP principles and of the Canadian Rx&D Code
Ability to work in high performance teams, and in a matrix organization. Excellent team player; must excel at teamwork in cross-functional groups. Must be able to interact successfully with a variety of individuals at the local, regional and global level, which include local clinical investigators, contract research organizations (CROs), payer administrators, regulatory officials and individuals of various patient advocacy organizations with a particular interest in our products and clinical trial outcomes
Language: Bilingual (French and English)

Associate Director Medical Affairs, Vaccines Resume Examples & Samples

Provides oversight and guidance to country medical colleagues about country medical affairs activities relevant for MSD products. Ensures alignment of country medical activities to franchise priorities
Provides medical expertise to Regional Marketing Leads (RMLs) and Regional Leadership (President, Chief Marketing Officer, Regional Medical Affairs Lead)
Voice of authority and information on franchise science in region (along with the RDMA)
Collaborate with the development of drafts agenda for regional Advisory Boards and may chair them as indicated by the RDMA
MD, PhD or PharmD is required; recognized expertise through 5+ yrs clinical and/or research experience (incl publications) in therapy area is desired
4+ years pharmaceutical or related industry experience in country with proven track record of contribution to commercial, medical and/or clinical development strategies in country (Not mandatory)
Strategic thinking, specifically related to life-cycle management strategy and execution
Customer expertise especially scientific leadership and other key stakeholders (public groups, government officials, medical professional organizations) in therapy area

Country Director Medical Affairs UK & Ireland Resume Examples & Samples

45%: People and Processes Management
Member of the Regional Medical Affairs Leadership Team and Cluster/Country Leadership Team
Work with RMA Head to define and secure the resources (staff, budget and capabilities) required to support GMA and R&D in the country/cluster
Coordinate with Human Resources / Talent Management to recruit, onboard, develop and retain country/cluster medical team
Coordinate with Head of Shared Medical Services and RMA Head to define appropriate and optimal service requirements and service levels
Coordinate with Global Medical Training and RMA Head to define and develop required team competencies
Monitor team performance in terms of goals and delivery against in-year medical plans and identify areas for development
Line manage and develop Country Medical Leads/Medical Science Liaisons
Define and oversee implementation of the country/cluster budget
Align and facilitate cross-functional support and collaboration, and consult the General Manager on all matters related to Medical Affairs
45%:Strategic Planning and Execution
Aligns and works closely with the country manager on the overall country strategic plans and ensures implementation
Is an active part of the local leadership team and other local steering committees
Develop and manage resource plan for the country (cluster) per strategy requirements
Lead the development of MA Plan in alignment with Regional MA and commercial country/cluster strategy
Supervise activities of country (cluster) medical team and actively manage allocation and budgets to ensure quality and timely delivery against medical plans
With RMA Head, support geographic expansion and establish required capabilities
10%:Establishment and maintenance of a compliant environment
Coordinate with Legal, Compliance and Regulatory to ensure appropriate systems, processes and training is in place in the country (cluster)
Ensure that all promotional materials and events are in compliance with Shire SOPs and policies, and local laws and regulations
Implement appropriate standards of practice (SOPs)
Lead by example to embed Shire values into the local business culture
A medical degree is required. Advanced scientific degree (PhD or equivalent) is acceptable if 8+ years of Medical Affairs and Management experience, incl. exposure to multiple (>3) Therapy Areas (TA)
GMC registration with no limitations to practice
ABPI certified with final signatory status
A minimum of 5 years of experience in biopharmaceutical medicine
A minimum of 4 years of experience in medical affairs is required
A minimum of 4 years of experience leading teams at the brand or disease area levels in country, regional or global organizations is required
Experience in field-based roles (e.g. Medical Director, Medical Advisor) is preferred
Focus on accountability and ownership – constantly challenging oneself and the team to take responsibility for continuous performance improvement and operational excellence
Ability to identify and establish strategic partnerships and collaborations internally and externally
Very good communication and listening skills
Able to comfortably lead multidisciplinary and virtual teams
Very good people management skills with demonstrated ability to set goals and objectives, and establish and recalibrate priorities
Solid judgement and decision-making skills, ability to adapt rapidly to evolving local business and landscape
Unquestioned ethics

Director, Medical Affairs Resume Examples & Samples

Doctor of Medicine, Board-certified in relevant medical specialty
Neurology or Psychiatry experience preferred
Previous experience in exploratory analysis of clinical trial data
May require up to 25%travel

Senior Director, Medical Affairs Resume Examples & Samples

Serve as medical and scientific medical affairs expert for assigned assets; develop and communicate key medical data elements and medical messages to respective colleagues; assist with medical training, medical information services, global medical communication and publication planning and execution
Represent medical affairs on company and alliance meetings; coordinate medical input from affiliates and alliance partners
Interact internally with and support colleagues from Alliance Management, Business Development, Government Affairs and Marketing
Manage the budget for the specific Cost Center and provide direction and oversight for the global MA lurasidone budget
Either directly, or indirectly through supervision, oversee the medical review and sign off of promotional pieces in support of business objectives
Coordinate publications and communications strategy by providing scientific and publication planning input, including review and sign off of materials for medical/scientific presentations and publications
Interact internally with senior level management requiring negotiation to guide the overall medical affairs activities for assigned programs
Develop and maintain relationships with international thought leaders through Advisory Boards, Professional Associations and Meetings to achieve company’s scientific objectives
Provide support for departmental initiatives and other duties as assigned
MD degree with board certification
7 plus years of experience in industry and/or academic research experience; or equivalent combination of experience in respiratory medicine

Associate Director Medical Affairs Resume Examples & Samples

15%:Develop and implement Global Medical Plans in focus disease areas at the country level
25%: Systematically lead identification of the scientific exchange needs of KOLs, investigators and other stakeholders in patient care, establish strong professional relationships, and provide credible scientific expertise
25%:Leading the design and implementation of best-in-class scientific programs with external KOLs, investigators and Global Medical Affairs and Global Clinical partners
20%:Manage the disease area Medical Science Liaison team,
5%:Oversee and participate in responding effectively to requests for scientific exchange
5%:Support local team disease area and product knowledge through scientific training
10%:Maintain personal and medical team expertise in relevant disease areas and Medical Affairs and Medical Research best practices
MBBS or BSc. In Pharmacy with PhD in science or specialty
ABPI certified final signatory
5+ years (with MD) or 8+ years (without MD) experience in biopharmaceutical medicine in Medical Affairs or Clinical Research is required

Associate Director, Medical Affairs Resume Examples & Samples

Maintains navigational electronic database to document on- and off-label unsolicited requests for information from HCPs in accordance with Haemonetics’ internal guidelines and FDA guidance for industry
Catalogs the nature of requests and information provided, ensures that internal files are up-to-date, all documents are appropriately archived and filed in accordance to Haemonetics SOPs and regulatory and legal requirements
Stays up-to-date on medical, legal, and regulatory guidelines pertaining to the distribution of scientific and medical information
Assists in Sunshine Act reporting requirements and legal contract reviews as appropriate
Leads the logistic and organizational aspects of medical affairs activities and meetings with both internal and external stakeholders, e.g., CRO, KOLs
Ensures compliant use of field materials as well as appropriate use of TEG products
Facilitates and manages cross-functional work-streams related to cataloging requests for information and providing resources for dissemination
Activation, tracking, and reporting of investigator initiated trial (IIT)-related information
Ensure all IIT program records are kept up-to-date and accessible for team use and audit-readiness
Prepares meetings and educational materials to provide scientific information to key stakeholders including but not limited to Haemonetics employees, contracted speakers, CROs, consultants
Supports the medical affairs team in establishing guidelines and appropriate training for MSLs

Director Medical Affairs Oncology Resume Examples & Samples

Address medical and scientific issues and to ensure the appropriate use of all Janssen Biotech marketed products for hematologic malignancies
Support the development of compliant promotional materials and the training of product representatives
Maintain relationships with external investigators and opinion leaders through Advisory Boards and international meetings
Support the development of scholarly publications arising from Janssen Biotech studies
Support the development of product monographs and responses to product inquiries
An MD is required
Board Certification in Medical Oncology, Hematology or Pediatric Hematology-Oncology is preferred

Director, Medical Affairs Asia Pacific Resume Examples & Samples

Development of Dermatology component of AP Medical Affairs Immunology Strategy
Development of Dermatology component of the MAF Annual Business Plan for immunology including data generation projects (clin studies, registries etc..) and data dissemination projects ( Medical education, publications etc)
Assist Immunology TA Lead in development and management of product and T&E budget for Regional MAF activities
Excellent knowledge of immunology in general with a good knowledge of all products within TA, particularly biologic inhibitors of TNF, IL-23 and related cytokines
Awareness of AP Regulatory and reimbursement environment
Highly customer and market place focused with an Big Picture orientation
Ability to work effectively in a matrix environment
Working in a matrix system
People management
Product Development Expertise
Publications and Scientific Presentations

Associate Director, Medical Affairs Resume Examples & Samples

Create, manage and track strategic scientific communications plans in a cross-functional manner
Content development: manuscripts, abstracts, posters, slide decks, monographs, etc
Develop in-depth therapeutic knowledge of disease, epidemiology, product and competitor product information; act as a resource to others external to Medical Affairs
Serve as medical communications contact and resource to internal teams, especially Project Teams regarding product and therapeutic area
Create and/or review for accuracy and strategic alignment communications containing medical and scientific content intended for internal and external customers, including a scientific communication platform
Proactively reach out and collaborate closely with members of other internal teams
Identify, collect and provide relevant information and input into business activities such as product and competitor insights, medical product plan and deliverables, new business assessments and other requests
Serve as authoritative source of medical/ scientific expertise
Scientific & Medical Communications lead for therapeutic area publication working groups or projects
Partner with Medical Directors to develop scientific communications
Ensure compliance with company policies and procedures
Maintain close interactions with Compliance, Clinical Development, Marketing and other internal and external stakeholders
Minimum 5 years of experience in Medical Affairs, Clinical Development or related field in the industry, preferably in Serious Mental Illness (schizophrenia, depression and/or addiction)
Excellent scientific writing skills and publication development experiences
Ability to lead initiatives and teams within Medical Affairs and cross functionally
Knowledge of pharmaceutical industry regulations, guidelines, standards and practices

Director Medical Affairs Operations Resume Examples & Samples

Leads and strongly supports close cooperation with all other departments within Medical Affairs and across Janssen Germany
Acts proactively and prospective with regards to parameter and guarantee of leadership of Medical Affairs Operations within the company and towards the external environment
Ensures 100% compliance with all internal and external guidelines
Captures the performance as well as the internal and external satisfaction of customers within his responsibility by suitable KPIs, ensures implementation of corrective actions as needed
Decides on resource allocation within the BP and controls the budget
Creates an open and transparent working atmosphere in the team and ensures the development of his employees
Travel activity 10%
Physician, PhD
7 years experience in a medical-scientific area with a minimum of 5 years in the pharmaceutical industry
Broad knowledge of national and international leadership
Knowledge of relevant EU healthcare codexes, especially AMG, HWG, HCBI and FSA
Knowledge of CRM
Excellent written and oral communication skills in English, German language skills is a Plus
Strong leadership and change management skills, motivator to the team
Strong communication and influencing skills
Strong commitment to JnJ Credo
A visionary and strategic thinker
Thinks entrepreneurial
Strong leader who implements goals & objectives by focussing the success of the company
Willingness to takes risks and decisions

Director, Medical Affairs Resume Examples & Samples

Support Leica Biosystems and other operating companies within the Danaher Life Sciences and Diagnostics segment in their pre- and post-market activities such as design specifications; regulatory submissions; review of marketing and promotional materials
Support the sales team in peer-to-peer interactions with customers and potential customers by providing medical and technical information
Provide input into strategic planning for clinical innovation
Generate medical and clinical consultations on risk assessments and be a member of the risk team
Ensure timely medical review and reporting of adverse events
Represent medical affairs at meetings of the adverse events subcommittee and field action subcommittee
Represent the Company in discussions with regulatory agencies about clinical matters relating to existing and future products
Reviewing marketing, advertising, promotional, scientific and sales materials for scientific accuracy and content
Participating in designated QA/RA meetings
Responding to customer and internal inquiries for medical/clinical consultations
Providing medical and clinical support for sales activities of Leica Biosystems, and (as needed) for Beckman Coulter, and other operating companies within the life sciences and diagnostics segment of Danaher
A deep understanding of/ experience with laboratory medicine and anatomic pathology. Must have M.D. degree with American Board of Medical Specialties certification in an appropriate specialty (anatomic and clinical pathology, preferred)
Molecular tissue pathology experience is required
Successful experience in advocating and advancing in vitro diagnostic products
History of planning and participating in global medical advisory boards and managing relationships with external experts
Prior interactions with regulatory agencies on pre- and post-market issues
Creative problem-solver with the ability to spot issues of significant importance early and partner with colleagues across Danaher and its Operating Companies to help solve them
Strong written and verbal communications skills, ability to act as a change agent through dynamic interactions with others; ability to give persuasive and engaging presentations to audiences of a wide variety of backgrounds
Ability to work in a matrix, multidisciplinary organization
Comfortable with ambiguity
Experience participating on a team to generate a vision, establish direction, motivate colleagues and employees, encourage diverse views, and encourage improvement and development
Experience working with a global team or demonstrated global sensitivity
Ability to set and monitor program objectives that are aligned with the global DHR LSDx segment
Demonstrated ability to manage and prioritize multiple projects. Highly motivated with the ability to be proactive, take initiative, and carefully monitor, follow through, and complete projects in a professional and timely manner

Executive Director, Medical Affairs Resume Examples & Samples

Give presentations on behalf of Cepheid at meetings and webinars around the world
Interact directly with customers with regard to product performance queries, discrepant results, etc
Prepare documents for Quality or Regulatory review as needed to satisfy Regulatory body requirements
Prepare or review customer-facing documents including Guidelines and Technical Bulletins, product inserts, and training materials
Write or assist in writing articles for publication
Engage with Clinical Affairs to optimize clinical trials activities
Engage with Marketing to help identify KOLs and shape messaging
Provide lab-based experience to assist R&D and Core Teams at all stages of assay development
Manage and works with Proficiency Test providers to optimize performance of challenges in our tests and investigate failures of our test on PT challenges
Helps identify and enlist input from experts in the field
Writes company-based articles, white papers, newsletters, and assists external investigators in study design and publication activities
Provide input to product development and strategy for the company

Director, Medical Affairs Resume Examples & Samples

Provides process and scientific support for the development and review of medical content including slide decks, presentations, publications and standard response letters
Participates in the review of promotional materials
Supports the medical publications program through interaction with medical writing vendors, authors approval processes, develops abstracts, posters and manuscript outlines and ensures compliance with internal guidelines
Manages educational grant procedure, applications and approvals, tracking and payment processes
Provides scientific training for field medical, commercial and vendors
Identifies and screens appropriate vendors, solicits and evaluates proposals
Supports, plans and attends (as required) scientific congress via pre-meeting planning and post-meeting reporting
Maintains and updates the Medical Affairs resource and Adamas literature libraries
Develops and /or supports Medical Affairs quality control activities including metrics analysis across activities (MSLs, publications, Phase IV and IITs) and file management
Manages the planning and execution (as necessary) of medical advisory boards, internal meetings, training and conference activities. Duties include, but are not limited to
MD, PharmD, PhD in a scientific discipline required, advanced degree preferred
Minimum of 6-8 years’ progressive experience in the pharmaceutical industry in medical affairs, medical communications, medical information, scientific affairs or similar area, or completion of a pharmaceutical industry fellowship
Neurology experience strongly preferred
Understands US healthcare environment, clinical research processes, FDA and other federal regulations, and ethical guidelines
Proven meeting planning and team facilitation skills
Ability to create, track and plan timelines and budgets along with managing multiple projects simultaneously
Excellent organization and multi-tasking skills
Strong interpersonal skills and problem-solving capabilities
Knowledgeable of database management systems, such as Veeva Vault, etc
Occasional travel (up to 25%) for conferences and meetings
Successful experience in fast-paced entrepreneurial environment
Fit with Adamas culture and values

Senior Director, Medical Affairs Resume Examples & Samples

Responsible for alignment with trial leaders, TMTT’s Biometrics, Regulatory Affairs, Global Healthcare Economics and Reimbursement (GEHR), Marketing, Strategy and Quality
Responsible for developing the clinical trial strategy for TMTT clinical studies
Provide program leadership support for the review of clinical and scientific aspects of regulatory filings, including technical summaries, labeling statements, IFU, Annual Progress Reports, and Clinical Evaluation Reports
Provides advice and counsel with respect to regulatory strategy. Collaborates with internal regulatory experts to ensure compliance with schedules for PMAs/IDEs/510ks and EU submissions
Partner with GEHR for study design to support reimbursement in major markets
Represents the TMTT business as extension of the senior leadership team to Investigators and trial committees
Responsible for global scientific communications strategy and execution. Develop evidence-based scientific communications plan (e.g., abstracts, publications, podium presentations) taking into consideration the value proposition of Edwards’ TMTT product portfolio, the dynamic competitive landscape, projected timing of clinical data availability. Proactively manage submission timelines for major scientific congresses globally. Ensure appropriate scientific content for submissions in partnership with cross functional teams (Biometrics, Clinical, Legal, Regulatory, GEHR, and Marketing) and physician investigators. Partner with KOLs to ensure effective podium and publication execution
Evaluate Investigator Initiated Studies (IIS) in alignment with strategic business objectives
Direct review and approval of educational grant applications including budgetary planning, review of applications, processing requests and ensuring compliance to legal guidelines
Lead professional education program strategy and execution. Develop education strategy and partner with KOLs to develop impactful programs. Ensure effective delivery of scientific content to maximize educational value and manage program execution
Provide input and guidance to Marketing on clinical matters to facilitate customer interactions
Develop an effective working relationship with multiple internal stakeholders including Clinical Affairs, Regulatory Affairs, Research and Development, Marketing and Sales
Develop a strong working relationship with various healthcare professionals including KOLs
Collaborate and partner with Legal and Compliance as well as other key cross functional business partners

Associate Director, Medical Affairs Resume Examples & Samples

Serve as the lead Global Medical contact for one or more of the key functions (e.g. Clinical Development, Commercial, or Market Access)
Serve as the Study Director and a core member of the study team for 1-2 Global Medical studies
Pharmaceutical industry experience required (5 years minimum). Relevant experience in Medical Affairs and clinical trial execution strongly desired
Ability to take initiative and solve complex and challenging problems

Director, Medical Affairs Resume Examples & Samples

Function as key strategic partner with Clinical Development, HEOR, Marketing, Regulatory, and Legal teams to execute medical life cycle plan; implementing strategies and tactics in support of brand development in the defined therapeutic area
Direct the coordination and utilization of scientific information that may be used by various internal stakeholders in support of marketed product(s) and drugs in development within the defined therapeutic area; this will include the establishment of relevant Advisory Boards
Provides strategic medical practice input to the Product Development Teams to ensure that appropriate phase IIIb and Phase IV studies are planned and executed to provide practice relevant data on the marketed products. In addition, provide inputs from medical practice perspective to HEOR team for real world studies as needed
Within the context of the strategic development and brand plans for each product and the therapeutic area, evaluate proposed research concepts and protocols for investigator initiated studies (IIT), assessing such IITs for medical/scientific merit, appropriate design and strategic fit for the product
In partnership with the marketing team, design and review promotional materials to ensure medical and scientific content is accurate, balanced, and competitive and provides input to the review process to ensure the best promotional materials are developed
Ensures that the training of external teams and/or sales professionals, on various aspects of scientific information specific to Forest products and on related medical/scientific information concerning the therapeutic area, is accurate and balanced to communicate the complete data about products
Attends periodic meetings of the publication team, reviews all materials for publications, and coordinates activities with publication/communication group
Directs the reviews of medical information and communication materials for medical and scientific content
Stays informed of current developments in the medical and scientific communities concerning assigned areas through appropriate familiarity with current literature, attendance at meetings, conventions, and professional associations
Act as external spokesperson to KOLs, Payors, Professional Societies, and Advocacy Groups. Key internal contact for Advocacy groups of global importance
Provides support for sales training initiatives for current products and drug product launches; reviewing and creating training materials and participating in clinical product training for sales representatives and others
Responsible for IME for products within assigned therapeutic area
Represent MA and hence medical practice in label negotiations with FDA
Subspecialty training in gastroenterology or related discipline is highly preferred
Current or recent work in clinical practice preferred, but not required

Associate Director Medical Affairs Resume Examples & Samples

Develop expertise in all medical areas relevant to designated CSL Behring products including analysis of current literature, opinion and recommendations
Work with marketing and other relevant staff to develop marketing strategies and supporting materials for designated products in local and global/regional markets
Be a proactive member of designated brand teams, especially in the provision of qualitymedical/clinical input that aligns with business operations. Provision of medical and clinical partnership in product launches, issues management and recall situations
Develop programs and activities appropriate to launch designated products, including training materials, standard responses (inc. medical information), product monographs, data updates, rep memos and other materials as required. Contributing to the education and training of relevant CSL staff, including sales representatives, marketing, medical, clinical research and regulatory affairs staff
Ability to represent the Medical Director, in his/her absence, in matters requiring Medical Director input
Attendance at relevant conferences and seminars

Director Medical Affairs Coagulation Resume Examples & Samples

Identify and evaluate new trends and therapeutic area opportunities that could lead to competitive advantages in cooperation with R&D and the regional commercial organizations. Monitor scientific progress and competitive activity in coagulation
Function as central company point of contact in coagulation for the medical community. Devise and implement global KOL strategy for assigned therapeutic area. Develop and maintain contacts to KOLs and patient organizations. Recruit and integrate external knowledge into internal developments and marketing initiatives in collaboration with regions. Maintain or develop strong relationships with key internal groups (including Commercial Operations Regions, R&D, Legal, Finance, etc.)
Represent the therapeutic area Coagulation in committees such as Safety Management Teams and Global Medical Affairs (GMALT)
Responsible for evaluation of requests for investigator led studies and research collaborations. Participate in ClinCom process for evaluation of investigator driven studies requests
Define and implement global publication strategy in collaboration with the responsible commercial and R&D counterparts. Chair and provide leadership to publication team
Identify, develop and implement medical affairs driven initiatives (i.e. congress symposia, advisory boards, medical education/grant program). Contribute to development of medical and educational core promotional material and publications. Provide input in to product development plans (Stage gate Process), in particular the clinical research program and design of clinical development plan (in collaboration with R&D). Represent commercial strategy to R&D via the project management process and project team forum
Fill role of medical expert for coagulation within commercial development and commercial operations. Provide medical/scientific assessments of product opportunities in collaboration with R&D. Support training of staff of key countries as appropriate
Take responsibility for Phase IV/PMS program and liaise with clinical R&D on its execution

Director Medical Affairs Resume Examples & Samples

Represents, leads and promotes Janssen as the scientific partner of choice through thought leadership and influence of key opinion leaders on the fundamental issues affecting the industry within the designated therapeutic areas
Oversees the design and implementation of Medical Affairs plans (both evidence generating and evidence disseminating) within their span of control and ensures the development of integrated evidence generation plans that are strategically aligned with the business
Seeks out and leverages opportunities for knowledge sharing on a global basis and develops new and innovative strategies to achieve scientific and business results
Attracts, develops and retains high-caliber team members, helping to build a medical and scientific pool to drive future success of Janssen Canada
Establishes a culture of high performance by focusing on the delivery of high priority, core activities within their teams
Develops and fosters strong collaborative relationships with internal partners including Regulatory Affairs, Global Clinical Operations, Access, Sales and Marketing to meet business objectives
Leads team in the development of differentiation platforms around key clinical and other health outcomes attributes
Supports the design, development and management of Phase II through IV clinical programs within Canada including Investigator Initiated Studies and other evidence generating activities to address Canadian needs
Interfaces effectively with the global partners to maximize lifecycle opportunities for products both locally and at a global level
Interacts with Key Opinion Leaders, Regulatory Authorities, and other external agencies in support of our products, therapeutic areas of interest and company objectives
A minimum of a Doctor of Medicine (MD) is required
A minimum of 10 years of relevant pharmaceutical industry experience is required, with prior experience in a senior Medical Leadership Role with a proven track record of significant success in leadership and strategy development
A minimum of 5 years of direct people management experience is required
Knowledge of multiple therapeutic areas is an asset
Exceptional leadership skills and the ability to work with and motivate teams
Excellent interdependent partnering ability, including ability to effectively work with customers and colleagues, and ability to work effectively in a cross functional team environment
Proven track record developing, presenting and publishing clinical studies
Demonstrated skills in identifying and developing solutions to data gaps using current best practise approaches to data generation
Demonstrated skills in the areas of sound judgement, people development, critical analysis, negotiation, and innovation7094170405

Director Medical Affairs Resume Examples & Samples

MD or OD with 2-5 years clinical/patient care experience
Prior experience with ophthalmology, device is a plus
Ability to interpret scientific literature; preferably demonstrated through history of authorship in peer-reviewed journals
Familiarity with regulatory and product development guidelines governing medical device industry
Ability to learn quickly and work independently in fast-moving environment

Director, Medical Affairs Resume Examples & Samples

Manage internal and external resources to advance the objectives of Medical Affairs and the organization
Lead the development of formalized product scientific strategy with input from Medical Director, MD consultants, and cross-functional teams; ensure clear and efficient communication of scientific strategy internally and externally
Ensure tactics align with product scientific strategy; communicate with internal and external stakeholders to track execution and progress and implement modifications where necessary
Identify opportunities for appropriate, relevant generation or communication of scientific data. Proactively manage portfolio publication pipelines in alignment with strategic plans
Provide scientific insight related to research areas of focus, oversight and review of global medical education, global grants program and external research priorities
Engage key opinion leaders, translating customer insight into strategic and tactical planning
Ensure compliant, timely, and accurate responses to requests for medical information (including unsolicited requests for off label information). Respond to and anticipate changes within the heavily regulated, compliance-driven medical communications arena
Collaborate with Clinical Affairs on study design and protocol development; including literature review, methods development, KOL and site identification, protocol revisions, medical soundness
Implement Scientific Review process for IITs, creating externally communicated scientific research priorities; manage review of submitted proposals: protocol assessment, investigator relationship management and alignment of expectations, assistance with publications
Research and provide reports on the clinical data in support of diverse corporate initiatives including regular journal tracking reports and summaries of key publications, as well as regulatory submissions (including Clinical Evidence Reports, IDEs and 510ks)
Acts as liaison and represent Medical Affairs in meetings and on committees as assigned
Participates in activities related to product support
Manages in order to ensure compliance with all relevant regulatory/legal requirements
Bachelor's Level of Degree in the science or technical field of study
12 years of demonstrated experience in medical affairs/clinical development for the medical device industry with a minimum of 5 years experience managing and leading staff
Advanced degree, Masters/PhD

Director, Medical Affairs Resume Examples & Samples

Work closely with marketing, clinical and executive management to identify clinical evidence study opportunities and priorities
Create a strategic map of relevant clinical study evidence by parameter / product
Provide review and input to clinical and scientific aspects of regulatory filings, including technical summaries, labeling statements, IFU, Annual Progress Reports, and Clinical Evaluation Reports
Provide advice with respect to regulatory strategy. Collaborate with internal regulatory experts to ensure compliance with schedules for PMAs/IDEs/510ks and EU submissions
Partner with GHER for study design to support reimbursement in major markets
Represent the TMTT business to Investigators and trial committees
Responsible for global scientific communications execution. Develop evidence-based scientific communications plan (e.g., abstracts, publications, podium presentations) taking into consideration the value proposition of Edwards’ TMTT product portfolio, the dynamic competitive landscape, projected timing of clinical data availability. Proactively manage submission timelines for major scientific congresses globally. Ensure appropriate scientific content for submissions in partnership with cross functional teams (Biometrics, Clinical, Legal, Regulatory, GEHR, and Marketing) and physician investigators. Partner with KOLs to ensure effective podium and publication execution
Review Investigator Initiated Studies (IIS) in alignment with strategic business objectives
Review educational grant applications including budgetary planning, processing requests and ensuring compliance to legal guidelines
Design professional education program strategy and execution. Partner with KOLs to develop impactful programs. Ensure effective delivery of scientific content to maximize educational value and manage program execution
Perform all responsibilities in full compliance with regulatory requirements, legal requirements, and industry guidelines
Supervisory Responsibilities: Provides scientific leadership and mentoring

Regional Director Medical Affairs, Vaccines Resume Examples & Samples

Participates in the development of Medical Affairs strategies (which are responsibility of the RDMA) for the region, which are aligned with and reflected in the Global Medical Affairs Plans for the franchise
Executes the Medical Affairs Plan in their own region, in collaboration with country medical affairs colleagues
Executes Scientific Leader event planning in their region from the GHH perspective in collaboration with MSD Vaccines’ Global Health & Medical Affairs (GHMA) team and GDSAs from the Research Lab perspective
Scientific communication through contacts, meetings and presentations with/for key Scientific Leaders and stakeholders in accordance with applicable policy and guidance documents
Voice of authority and information on franchise science in region
Collaborate with the development of drafts agenda for regional Advisory Boards and may chair them
Contribute to Cross-Functional Team that brings together medical, commercial, policy, access, and communications leaders
The ideal candidate would have experience in either (or both)

Scientific Director, Medical Affairs Resume Examples & Samples

Manages the design and implementation of one or more clinical development programs in support of an overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations and emerging issues
Oversees project-related education of investigators, study site personnel and AbbVie study staff
May oversee the work of Associate or Assistant Scientific Directors and of Clinical Scientists working on the same or related programs
Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific activities with internal stakeholders as they relate to ongoing clinical projects. May participate in due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies
Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions

Exec Director, Medical Affairs Resume Examples & Samples

Provide leadership and direction to staff with oversight for MAF managed programs
Responsible for design, implementation and execution of EUMEA regional medical plans in coordination with Product Development and Commercial Operations
Foster collaboration between EUMEA MAF and other departments at a global and regional level
Ensures that global strategic R&D plans are implemented at a regional level in collaboration with head of EUMEA R&D
Ensures close collaboration with Market Access team to ensure timely, adequate and scientific rigorous HEOR planning
Ensure that staff and vendors are adequately trained to perform their functions and are following company SOPs and ICH guidelines. Assure proper and timely implementation of programs globally
Direct development of MAF managed program specific SOPs as needed and ensure they are in alignment with corporate SOPs
Create objectives that are in-line with corporate and global MAF goals, are measurable; facilitate effective communication so that goals are understood by MAF staff and updates to senior management are consistent and timely
Manage performance of direct reports – including recruiting, hiring and retention. Provide guidance to line managers so that teams are getting the guidance and training necessary for personal and program success
Facilitates core training and professional development for all levels of direct reports
Provide direction and support to staff so that they become proficient in identifying and resolving problems that can affect the short- and long-term goals of EUMEA MAF
As member of the extended global MAF leadership team provide input into plans for new programs and company initiatives that impact global MAF. Develop plans to meet company-defined goals within corporate and regulatory guidelines for products both marketed and in development
Work with senior management to develop plans for organizational change to support growth. Guide and facilitate organizational change/development activities. Included in this responsibility are developing communications that describe why change is needed and how change is to occur; help staff understand changes and the impact they have on their roles and responsibilities
Develop strategic business relationships with stakeholders both internal and external
Responsible for providing medical affairs input into development, execution and interpretation of clinical protocols for GMAF run clinical studies. This includes review of draft IR protocols, reports and manuscripts
Assist in critically evaluating study results in statistical and final reports as well as ongoing reviews with study investigators, resolving problems arising in the course of clinical investigations and preparing reports to the management and medical community
Very strong Pharmaceutical experience preferred
Strong Medical Affairs experience is essential
Previous management experience in Medical Affairs and/or Clinical Development is essential
Up to 50% travel requirement
Experience in public presentations

Executive Director, Medical Affairs Resume Examples & Samples

A minimum of 3 years experience in field medical affairs leadership and 3 years of experience in the health systems (e.g., payer, organized provider) space inside or outside of the biopharmaceutical industry
A thorough understanding of the evolving health systems landscape to include payment, quality and policy changes
Ability to effectively engage Merck Senior Management to develop and articulate USMA franchise vision and strategies
Excellent interpersonal communication and presentation skills, strong personal integrity, teamwork abilities, strong business and financial acumen, and a customer focus are necessary
A thorough understanding of the FDA, OIG, HIPAA and other ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with external and internal guidelines and standard operating procedures
Must be able to organize, prioritize, and work effectively in a constantly changing, ambiguous environment and to motivate a team to do the same

Director, Medical Affairs Resume Examples & Samples

Understanding of country Medical Affairs strategy and tactics, competitors, and Neuroscience and Vaccines Franchise priorities. Direct Medical Affairs activities in support of clinical research efforts, strategic local regulatory approach (registration and labeling needs) and reimbursement needs
Support the Neuroscience and Vaccines teams in determining medical and scientific gaps, CSL needs: voice of the customers, medical guidelines, medical practice, CSL expertise, individuals CSL needs
Overall responsibility for the development, prioritization, and delivery of strategic and tactical plans that addresses identified gaps
Financial accountability for the overall TA Budget, projects' milestone completion and forecasting. Responsible for generation and reporting on the required performance metrics periodically for the respective TA. Responsible for the implementation and evaluation of TA effectiveness
M.D., Ph.D. or PharmD. Degree, with 7-10 years of Industry experience in Clinical Development and/or Medical Affairs, preferably in Neuroscience and/or Vaccines
Experience: 3-5 years of people management experience in Clinical Development and/or Medical Affairs is required
Experienced Medical Pharmaceutical Leader, with extensive knowledge of the pharmaceutical industry
Keen understanding of strategic clinical development and principles of study design
Advanced negotiation, presentation and facilitation skills. Excellent written and verbal communication skills
Strong planning and tracking skills, well-organized, focused on results, capable of managing multiple projects with respect to priorities and self-management
Ability to work in high performance teams and in a matrix organization. Excellent team player. Must excel at teamwork in cross-functional groups. Must be able to interact successfully with a variety of individuals both within and outside Merck Canada and the EUCAN Region, including internal and external stakeholders
Strong ethics and integrity. Solid knowledge of GCP principles and of the Innovative Medicines Canada Code of Ethical Practices
Position based in Head Office, Kirkland, QC (relocation assistance is possible)
Language: Bilingual (English and French) preferred

Senior Director, Medical Affairs MD Resume Examples & Samples

Responsible for direct management and medical input in support of key medical messaging such as core claims documents and monograph etc
Responsible for the development of a Medical Affairs Plan for appropriate products or therapeutic areas
Responsible for providing medical input into development, execution and interpretation of Phase I, II, III and IV clinical protocols.This includes review of draft IR protocols, reports and manuscripts
Oversee clinical registries and evaluate safety issues associated with products and promotional activities for BioMarin products in accordance with respected regulatory requirements
Responsible for direct interaction with investigators, KOLs and the research community to support company initiatives within the region
Responsible for representing BioMarin at scientific, clinical and business development meetings
Direct medical writing activities associated with Medical Affairs to ensure accurate execution of product dossiers, product related slide decks, standard response letters, FAQs as well as corporate abstracts, posters, oral presentation and manuscripts when appropriate
Promote effective communication between internal and external groups regarding Medical Affairs initiatives
Act as a key member of the IRRC and MPRC committees
Present at training courses, sales conferences, regional meetings, etc. to develop high level of medical knowledge within the organization
Travel within the EUMEA region and to the U.S. will be expected
Industry experience, preferentially in orphan diseases
Clinical trial and publication experience is essential
Knowledgeable and current in GCP guidelines in Europe and the US
Willingness to travel approx. 30% (also international)

Associate Director, Medical Affairs Resume Examples & Samples

Lead the execution of Post Approval Safety commitment (mandated by EMA which impact RMP) in collaboration with the safety group (Lead SMT, reports to CDT)
Act as a key point of contact between Medical Research Operation group and the patient registries
Develop collaboration/long term partnership with MS registries
Develop/build collaboration with SMA registries (in close collaboration with the Medical Director SMA Lead EU+)
Lead the Real Word Evidence Champion Network
Support the Head of Regional Medical Research Operation with tracking and update of the medical dashboard

Associate Director, Medical Affairs Resume Examples & Samples

1-5 years of experience in patient care or within a health system beyond doctoral training program. May include fellowship, residency or work experience
Basic understanding of healthcare delivery system in the United States
Excellent interpersonal, communication, and networking skills
Must possess basic understanding of the FDA, OIG, HIPAA and other ethical guidelines relevant to the pharmaceutical industry

Associate Director Medical Affairs Resume Examples & Samples

Ensuring local legislation is followed for all medical activities in each Nordic country
Identify, build and maintain KOL relationships and external stakeholder relationships relevant in the Hem/Onc franchise
Develop and implement strategic direction for the Medical department in all Nordic countries within the Hem/Onc therapeutic areas
Enable a strong cross collaborative relationship with Commercial, Market Access and Corporate Affairs
Develop and design of medical information materials and presentations
Stay up to date with trends, new data and best practices within the medical field in relevant therapeutic areas
Together with the RMLs, support the commercial organization with relevant training
Evaluate and profile potential investigators/sites to participate in clinical development studies and supervise the performance and progress of clinical trials
Initiate, coordinate and provide clinical protocol expertise to physician investigators by collaborating, reviewing, evaluating and assisting with the development, implementation and publication of Investigator Initiated Trials (IITs)
Participates and collaborates with international Medical Affairs team
Lead planning, execution and reporting of key medical projects (e.g., Advisory Boards, communication events, Satellite Symposia, etc.)
Support the Regulatory team and Access team with scientific advice as needed in their communications with stakeholders on regulatory and reimbursement matters for Celgene products at any registration stage and indication
Responsible for Medical Affairs H/O budget
Solid experience in pharmaceutical industry
Leadership experience in a Nordic function
Experience in sales force and/or Medical Affairs Department or Clinical Operations department of local affiliate
Demonstrates excellent communication and presentation skills
Demonstrates strong management and leadership skills
Displays strong organizational and time management skills; multi-tasks effectively; serves as a role model for completing tasks and delivering on commitments in a timely manner
Demonstrates a strong customer orientation; is science-based and marketing-minded, with strong business acumen
Acts as a role model for others in line with Celgene Values and Celgenes Leadership Success Behaviors

Director, Medical Affairs Resume Examples & Samples

Building and maintaining relationships with the health care community, including via medical education
Clinical communications and publications (including manuscripts, white papers, abstracts and posters) about products and therapeutic landscape- without making promotional claims
Supporting medical/clinical research and outcomes research
Pharmacovigilance/vigilance/safety , including responding to questions from healthcare providers about product safety, efficacy, dosing and administration
Managing relationships with thought leaders and key organizations
Assisting with product launch and with training of other Medline employees about products and therapeutic landscape
Response to questions from clinicians, as needed, about Medline products and technologies that arises from the normal business activities of Medline in commercializing such products
Medical Interactions/Scientific Exchanges-including responding to unsolicited requests for off-label information in accordance with FDA guidance; distributing scientific and medical publications on off-label uses in accordance with FDA guidance; appropriate scientific discussions at legitimate scientific or medical conferences
Product Advisory Boards and Independent Medical Education Grants (CME, CE)
Ensures all Medical affairs initiatives are aligned with overall brand plans and are in compliance with corporate policies and regulatory requirements
Commitment to provide leadership by example

Associate Director Medical Affairs Resume Examples & Samples

M.D. degree of a recognized school of medicine, PhD, or PsyD with + 3 years experience in pharmaceutical industry Medical Affairs specifically for neuroscience products
Pharmaceutical industry experience in Medical Affairs or Clinical Development (+ 6 years experience) for neuroscience products would also be considered
Good knowledge of OPDP promotional regulations and pharmaceutical promotion standards
Good knowledge of CDER/CBER regulations regarding evaluation and approval of pharmaceuticals

Director, Medical Affairs, Oncology Resume Examples & Samples

Address medical and scientific issues and to ensure the appropriate use of all Janssen Scientific Affairs marketed products for hematologic malignancies
Provide clinical analysis and support for Janssen Scientific Affairs products for hematologic malignancies
Provide medical monitoring and medical oversight for company sponsored Medical Affairs led interventional and observational clinical trials
Support the development of scholarly publications arising from Janssen Scientific Affairs studies
Board certification in Medical Oncology, Hematology or Pediatric Hematology-Oncology is strongly preferred
A minimum of two years of Medical Affairs and/or Clinical Research & Development experience in the pharmaceutical industry, or one year's pharmaceutical industry and three years' relevant clinical experience in academic medicine is strongly preferred
Experience in clinical trial design and conduct (Phase II and III), including interventional oncology clinical trials is required
Position requires up to 25% annual travel (primarily domestic with some international travel)3527170614

Director, Medical Affairs Resume Examples & Samples

This position is appropriate for a medical doctor or similarly trained individual
Prior clinical practice preferred, but no mandatory
Candidates throughout the US will be considered

Director Medical Affairs Resume Examples & Samples

Serves as member of development and brand teams for Otsuka oncology products
Works with marketing and legal departments to review promotional and other product materials in accordance with FDA and other applicable regulations
Serves as a source of medical expertise on Otsuka clinical trials for in-house customers
Proactively acts as a liaison between the commercial group and the global medical and clinical development organizations
Develops annual publication plan and prepares (or organizes preparation of) manuscripts, presentations, and posters
Interacts with experts in the field to obtain feedback on products and advice regarding further development
Provides input into the creation of marketing materials and ensures data is accurately and effectively communicated
Provides input into regulatory documents
Reviews continuing education and unrestricted grants as well as investigator-sponsored studies proposals
Reviews safety information generated by Pharmacovigilance, takes part in discussions regarding interpretation of safety findings, and assists with periodic and other safety reports
Participates in creation of materials for field medical liaisons, participates in training of MSLs
Works with HEOR department for creation of dossiers and to provide direction for planning and execution of HEOR research
Coordinates with sales management to provide training to sales staff
Provides direction for medical information specialists
Participates in extramural conferences and scientific meetings to maintain awareness of research in the field
Keeps abreast of current state-of-the-art developments relating to in-house medical program focus, and provides education to clinical staff and other project team members, as needed
May be asked to provide input on feasibility of a drug candidate during pre-clinical and clinical studies
May participate in the evaluation of potential in-licensing candidates
Requires extensive understanding of oncology products, commercialization strategy, regulatory issues, and the pharmaceutical industry in general
Maintains a current awareness of new drug developments in targeted therapeutic areas
Strong scientific background and solid understanding of the pre-clinical and clinical development processes
Solid statistical knowledge with a demonstrated ability to interpret study findings and communicate appropriately
Skilled in managing people and getting points across in matrix environment
Demonstrated ability to effectively present scientific information (written information and oral presentations)
Thorough knowledge of promotional regulations and pharmaceutical promotion standards
Knowledge of CDER/CBER regulations regarding evaluation and approval of pharmaceuticals
Deep understanding of US pharmaceutical safety reporting and surveillance
MD or PhD, PharmD with extensive demonstrated experience will also be considered
Minimum of 8 years of experience in the industry, with at least 5 years in the oncology field in the US Medical Affairs role
Having had a prominent role in the launch of a product in the US market a strong plus

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