Global Medical Affairs Resume Samples

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T Harris

Thomas

Harris

8968 Beatty Mountains

Detroit

+1 (555) 491 3855

8968 Beatty Mountains

Detroit

Phone

p +1 (555) 491 3855

Experience Experience

Boston, MA

Global Medical Affairs

Boston, MA

Steuber, Kohler and Turner

Boston, MA

Global Medical Affairs

Planning, designing and managing global medical Advisory Boards
Serving as Global Medical representative on standing and project-based cross-functional teams
Develop and maintain knowledge of global pharmaceutical regulations, guidelines, codes of practices and Shire policies related to all medical activities
As delegated by the GMTL, lead functional (e.g. publications, medical communications, medical training) and relevant R&D teams in developing plans supporting global medical prelaunch strategy
Supporting design and execution of clinical studies (phase IV, disease registries, epidemiological studies, outcomes surveys, etc.) in close collaboration with Therapeutic Area Clinical Development head and Global clinical Operations
Collaborate with alliance partners at Regeneron: take a team-oriented approach to making sure strategy is clearly defined and consistent with relevant stakeholders in clinical development and commercial teams
Assists with organization of medical affairs meetings for luspatercept strategy with cross-functional team members and capturing meeting minutes and action items

Boston, MA

Global Medical Affairs Associate

Boston, MA

Kris, Kohler and Mayert

Boston, MA

Global Medical Affairs Associate

Manage logistics including purchase orders and submitting invoices
Manage grant review process, maintaining and updating Grant submission portal
Interface with meeting management company
Lead study start up process for ISS (perform, document and track training)
Liaise with contract research organization, research vendors and/or clinical sites legal to manage contract process for special projects/studies
Lead management, set-up, invitations, and contracts
Develop process for continual audit and maintenance of all publication files

present

Chicago, IL

Global Medical Affairs Leader

Chicago, IL

Tremblay-Lakin

present

Chicago, IL

Global Medical Affairs Leader

present

Provides Medical and Scientific Affairs input into overall Business plan
Provides oversight for direct reports, including setting of individual objectives and performance evaluation on an ongoing basis and at regular review sessions, and talent development
Develops and executes study protocols for Roche Sponsored studies, in collaboration with key stakeholders, to produce high quality data to support the goals of the strategic Medical Affairs Plan
Generates medical and scientific information materials; develops and executes publications plan; authors and reviews of scientific publications, including abstracts, posters, manuscripts and whitepapers
Plans, develops, and generates content and delivery of internal and external scientific and educational programs
Contributes to, reviews and approves medical/scientific communications including marketing materials and participates in Promotional and Scientific Content Approval Processes
Establishes and maintains ongoing long-term collaborative peer-to-peer relationships with Global key thought leaders and leads Global Key Opinion Leader activities including Medical Advisory Boards; aligns with IBT and Regions to ensure transparency regarding KOL activities

Education Education

Bachelor’s Degree in Science

Central Michigan University

Bachelor’s Degree in Science

Skills Skills

Expert in Disease Area with at least 5-7 years of clinical experience in the disease area, and good understanding of KOL landscape
At least 7 years of clinical trial experience, either in academics, cooperative groups, or industry
Intimate working knowledge of the role of Medical Affairs within industry
Strong interpersonal skills and demonstrated success achieving results through cross-functional matrix teams
Good understanding of GCP, statistics, and clinical trial designs
Good understanding of commercial drivers of success
10+ years of experience academia/industry
Gain an understanding of careers in the pharmaceutical industry
Gain knowledge and awareness of the function and role of Medical affairs in the pharmaceutical industry
Advance development of personal characteristics of behavior and professional attitudes reflective of high moral and professional standards, emotional maturity, and personal and professional integrity

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15 Global Medical Affairs resume templates

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Global Medical Affairs Operations Associate Resume Examples & Samples

BA or BS required; degree in science or life-sciences preferred
Minimum two years’ experience in project coordination; experience in clinical trial administration preferred
Excellent analytical, communication, and writing skills required
Advanced proficiency in Microsoft Word, Excel, PowerPoint, and database administration experience required
Document management software experience preferred
Regulatory experience preferred
A minimum of two years experience in high-volume project coordination
Two years experience in the pharmaceutical industry with regulatory background preferred
Attention to detail, follow through, negotiation skills
Database administration experience
Ability to work in a proactive and service oriented manner
Ability to multi-task and work in a high pressure environment

R&D IT Service Manager for Global Medical Affairs Resume Examples & Samples

Service owner
Service-level manager
IT service-continuity manager
Supplier manager (for the R&D function(s) covered)
IT operations manager
Bachelor's degree in computer science, information systems, business administration or other related field (or equivalent work experience)
ITIL certification (preferably for service management, which implies ITIL Service Management Practitioner certification) and project management training certification (preferred)
Typically at least five to ten years of IT work experience and three to five years in an R&D organization related to the service function in an environment similar in size and complexity to the organization (required)
Demonstrable and recent experience in service operations/managing an external service provider
Strong knowledge of IT Computer Systems Validation processes is required

Global Medical Affairs Operations Specialist Resume Examples & Samples

Assist in the management of Shire’s Global Independent Medical Education request management system
Assist with management of projects and processes for assigned therapeutic areas and geographies, including daily management of review and approval processes, contracting, budget management, metrics tracking, and participating in vendor management
Collaborate with GMA Operations Lead, GMA Operations Manager, GMA teams, Legal and Compliance partners to define system and process requirements
Support GMA Operations Lead in defining approaches to harmonize legacy processes and/or define requirements for new GMA processes
Support the identification of best practices for project management
Assist with development and management of procedures, communication and training for IME
Provide input into the development of SOPs, procedures and implementation of training for pertaining to IME
Support development of periodic communications regarding program updates and metrics
Track and report project performance
Under guidance from GMA Operations Lead, develop and implement metrics and reporting process
Per the defined process, track and report project metrics to GMA and other Shire stakeholders
A relevant scientific Bachelor’s degree (BS or BA) is required,
>3 years of experience in the biopharmaceutical industry, preferably within a matrix organization
Experience in executing projects
Experience in managing vendors
Knowledge of medical affairs customer interaction and documentation best practices, legal and regulatory requirements, Codes of Practice, Standard Operating Practices and guidelines is required
An advanced medical, science or business degree (Masters of Science, MBA ) is preferred
>1 years of experience managing and/or developing grants is preferred

Director, Global Medical Affairs Resume Examples & Samples

Work with the GMTL and Global Medical Team (GMT) to develop global medical strategy that include scientific communication platform for the disease area / brand(s) in both pre- and post launch setting
Support development of the in-year medical tactical plan and budget for the global initiatives
As delegated by the GMTL, lead functional (e.g. publications, medical communications, medical information and medical training) plans supporting global medical strategy
As delegated by the GMTL, collaborate with commercial to ensure aligned and medically appropriate commercial strategy, planning and execution
As delegated by the GMTL, participate in product development strategy and provide medical affairs and R&D inputs
40%: Implementation in-year of US and global medical strategy
Serve as a key medical resource on the disease area and on specific product
Develop and maintain knowledge of global pharmaceutical regulations, guidelines codes of practices and Shire policies related to all medical activities
As directed by the GMTL, develop, conduct, or participate in therapeutic training programs for Shire internal department
A Doctor Degree in Medicine (MD) is required
Board certification in ophthalmology is preferred or at least 4 years experience working in industry or in research institution in ophthalmology or ophthalmology product/development candidate

Director, Global Medical Affairs Lead Resume Examples & Samples

Work with the Global Medical Affairs Head, Pipeline, to develop and execute multi-year global medical strategy for the specified Product/Disease Area, appropriately aligned with overall strategy and incorporating R&D functional strategies (clinical, regulatory, HEOR, PV, compliance) in accordance with the Pipeline Operating Model (POM) and the Global Medical Team Charter
Work with the Global Medical Affairs Head, Pipeline, on the development and in-year implementation of the medical plan in accordance with the POM. Head the Pipeline Medical Team (PMT) for the product, and, when appropriate, the Global Medical Team for the product
Serve as Global Medical representative on standing and project-based cross-functional teams (PSTs, GDTs, ECTs etc)
As needed, provide Medical review to New Product (Commercial) non-promotional materials, and, eventually, commercial promotional materials following drug approval
Act as a company representative interacting with external scientific leaders, patient advocacy groups, professional societies and/or regulatory authorities
Establish appropriate strategic partnerships with centers of excellence and KOLs in areas related to transplantation
As directed by the GMA Head Pipeline, develop, conduct, or participate in therapeutic training programs for Shire internal departments
A medical degree is required, with sub specialization in nephrology, transplant nephrology (preferable), or transplant surgery (preferable)
Experience in medical affairs is required
Experience leading teams at the brand or disease area levels in country, regional or global organizations is preferred

Global Medical Affairs Resume Examples & Samples

50%: Work with GMTL on defining and implementing GMA strategy and prelaunch plans
Support execution of the in-year medical tactical plan for the global initiatives
As delegated by the GMTL, lead functional (e.g. publications, medical communications, medical training) and relevant R&D teams in developing plans supporting global medical prelaunch strategy
30%: Interaction with internal and external stakeholders in alignment with customer needs and medical strategy
Present data on product / therapeutic area
Planning, designing and managing global medical Advisory Boards
20%: Maintenance of knowledge base
Serve as a key medical resource on the disease area and on specific programmes

Global Medical Affairs Leader Resume Examples & Samples

A minimum of a MD or equivalent degree is required with specialty training and certification in rheumatology is preferred
A minimum of 10 years of combined relevant experience in a medical/clinical environment and/or scientific function in the pharmaceutical industry is required, with a minimum of 5 years in the Medical Affairs environment preferred
Previous clinical and/or pharmaceutical experience in Immunology is preferred
Previous experience in rheumatology disease area and an established network with medical experts/opinion leaders in rheumatology is preferred
A demonstrated track record leading highly matrixed, cross-functional work teams comprised of high-level contributors is required
In-depth knowledge of study methodology, study data reviews and analysis is required
Proven ability to act as a medical spokesperson for external audiences is required
This position is located in Horsham, PA or Titusville, NJ and will require up to 35% domestic and international travelMedical Affairs

Global Medical Affairs Lead Resume Examples & Samples

Develop and execute successfully Global Medical Affairs strategy
Support safety & risk management team on analysis of medical illnesses and complaints related to our marketed products
Build and communicate the deepest medical knowledge
Ensure appropriate scientific communication internally and externally
Give medical and scientific guidance on selected global initiatives within the Global Development and Global Marketing Project teams
Deliver specific medical affairs expertise to promotional material and marketing plans
Lead KOL stakeholders’ management inclusive of advisory boards, speaker bureaus etc…
Drive medical education activities and digital HCP engagement
Coordinate and lead global medical affairs projects
Medical doctor degree preferably with pediatric/pediatric nutrition background, or an advanced degree in nutrition, MBA highly desirable
At least 3-5 years’ relevant experience in the pharmaceutical / nutrition industry
Excellent verbal & written scientific communication skills
Previous experience working in cross-functional teams

Global Medical Affairs Director Resume Examples & Samples

MD, PharmD or PhD with unique knowledge for successful clinical program development and execution required OR an MD with specialty with board certification
Proven ability to interpret, discuss and represent efficacy and safety data relating to the assigned area
Demonstrated ability to establish strong scientific partnership with key investigators in assigned TA
Exposure/experience with rheumatology is necessary
Real World Evidence experience/exposure is highly desired

Global Medical Affairs Director, Glaucoma Resume Examples & Samples

For the assigned Medical Affairs studies (Phase IIIB-IV, PMS, observational studies without regulatory impact) within program/brand, as a member of the Global Medical Affairs Team (GMAT), provides medical scientific input to, e.g
Build together with the GBMD Medical Affairs strategy a highly influential medical and scientifically based platform
Fluent English (Oral and Written)
Proven ability to work both independently or in a cross functional team setting, including a matrix environment
Experience with ophthalmology is a strong plus
Must have Country/Regional/Global Medical Affairs experience

Global Medical Affairs Director, Dermatology Resume Examples & Samples

Support and execute on the Global Medical Affairs strategy and plan for the Atopic Dermatitis indication for Dupilumab
Establish and maintain strong relationships with experts in the Dermatology field, academics and professionals and/or patient associations. Prior knowledge of and established relationships with key opinion leaders in Atopic Dermatitis considered an asset
Organize and Lead advisory boards or roundtables for anti-IL-4/IL-13 in Atopic Dermatitis and gain strategic insights for medical, scientific, and development strategy
Give significant input to publications and co-author relevant abstracts. Drive process of data dissemination and ensure that it is publically presented in an appropriate and timely fashion and in a fair and balanced manner
Execute on life cycle management plan for Dupilumab; define and prioritize the future needs including new study ideas and tactics to prioritize the best areas for clinical trial investment
Responsible for promotional review activities in preparation of, throughout and after launch activities
Collaborate with the Alliance to execute the data generation activities in alignment with the Brand plan and Global Medical Affairs Plan
Coordinate some key Medical Affairs activities with Regional or country –based Medical affairs in charge of Dupilumab Atopic Dermatitis
MD or PhD required
Minimum 6 years’ experience in industry medical affairs
Global experience highly advantageous
Experience in Medical Affairs with Biologics (Dermatology, Rheumatology, Gastro others..) highly advantageous
Able to work on projects in coordination with Regeneron and establish excellent working relationships and credibility
Excellent communication and presentation skills with the ability to present scientific data in a credible manner. Able to interface professionally with a wide spectrum of internal and external academicians, agencies, and industry executives in the scientific/medical arena
Strong understanding of the pharmaceutical/biotech drug development and commercialization process
Leadership skills; personal style that includes a sense of urgency, as well as flexibility and ability to respond to rapidly changing environments and circumstances

Global Medical Affairs Resume Examples & Samples

Support the execution of the Global Medical Affairs strategy and plan for the Atopic Dermatitis indication for Dupilumab
Support the execution of the Medical Affairs activities such as Advisory Boards, International experts forum, round tables lead by the Global Medical affairs Team
Coordinate and support some key Medical Affairs activities with Regional or country –based Medical affairs in charge of Dupilumab Atopic Dermatitis
When needed interact with experts in the Dermatology field, academics and professionals
Coordinate the publications and abstracts/poster dissemination in various countries during the peri-launch period of Dupilumab. Stay in contact with the medical Affairs leads in the Regions and countries to ensure their needs are met
Serve as a liaison for Medical Affairs and Medical Information on the needs in the countries regarding Standard Letters or specific questions from HCPs and experts
Coordinate and provide regular information to internal stakeholders on the Global Medical Affairs projects to ensure the consistency in deliverables and timelines
Support the data content accuracy use for promotional review activities in preparation of, throughout and after launch activities
Support the Head of Global Medical Affairs Dupilumab Atopic Dermatitis in the build and execution of Global Med Affairs Plans
Travel required, comprising approximately 10-20%
Ph D, PharmD or MD required
Minimum 10 years’ experience in Pharmaceutical Industry ( R&D or Medical Affairs )
Prior experience in a Country, Global or Regional R&D or medical affairs role
Experience working within an international company with a complex organizational environment; able to operate in a matrix team oriented structure
Experience in scientific positions in Pharma Industry
Medical Affairs experience or pharmaceutical/biotech drug development process is an advantage
Able to work on projects in coordination with internal Global Medical Affairs team and with our partner -Regeneron
Able to interface professionally with a spectrum of internal and some external stakeholder (agencies, CROs etc..) the scientific/medical arena
Highest integrity; committed to ethics and scientific standards

Global Medical Affairs Director, Pain Resume Examples & Samples

Global Medical ‘point of contact’ for the designated medicine(s) within the Pain franchise. Responsible for medical and scientific leadership and support to current and future commercialized medicines, and issues management for current medicines
Provide medical contribution in the development of the global strategic brand plans and operating plans, in collaboration with other cross-functional teams
Accountable for the development and execution of the Global Medical Affairs plan. These will include responsibilities such as Phase IIIb/IV trial activities (such as protocol development, medical governance and interpretation of results); development of Key Opinion Leader strategy and plan; scientific congress activities (such as medical symposium, presentation of abstracts and or posters); input to publication strategy and review of Investigator Sponsored Studies
Coordination and execution of overall medical strategy for Teva’s Pain specialty brands in close collaboration with Regional Medical Affairs teams, from initiation of regional pre-launch activities to several years post-launch
Contributor and support the Global Medical Matrix Team responsible for the world-wide medical pain strategy
Advise clinical development with input on late stage development plans, target product profile, health economics and outcomes research needs and lifecycle management
Develops and maintain professional relationships with external experts and professional associations including therapeutic guideline development groups. Responsible for the External Expert interface for the respective pain medicines
Serve as an internal medical expert for product and disease-related content, product labeling, and Pharmacovigilance teams
Clinical background experience
Minimum of 5 years of pharmaceutical industry experience and clinical research experience
Pain or CNS and Medical Affairs experience preferable
Experienced and adept at working collaboratively across different cross-functional teams such as commercial, R&D, health outcomes, regulatory, pharmacovigilance and compliance
Leadership experience in developing strategy and executing medical plans, and in building professional external expert networks
Broad knowledge of drug development, clinical trial design, regulatory requirements, business development and life cycle management

Global Medical Affairs Director Resume Examples & Samples

Global Medical ‘point of contact’ for the designated medicine(s) within the migraine & headache franchise. Responsible for medical and scientific leadership and support to current and future commercialized medicines, and issues management for current medicines
Coordination and execution of overall medical strategy for Teva’s migraine & headache specialty brands in close collaboration with Regional Medical Affairs teams, from initiation of regional pre-launch activities to several years post-launch
Contributor and support the Global Medical Matrix Team responsible for the world-wide medical migraine & headache strategy
Interface effectively with other Global Medical Affairs functions such as Scientific Communications and Health Economics and Outcomes Research, and other departments, including Commercial, Clinical Development, Regulatory Affairs and Pharmacovigilance
Partner with all relevant functions on compounds in phase IIa/b development by providing Medical Affairs expertise and guidance when needed
Collaborate with Global Scientific Communications in support of knowledge generation for the migraine & headache franchise, including strategy development and review of manuscripts, abstracts and posters as part of the publication team
Develop and maintain professional relationships with external experts and professional associations including therapeutic guideline development groups. Responsible for the External Expert interface for the respective migraine & headache medicines
Education: MD required. Has worked as a practicing clinician. Additional qualifications advantageous
Experience:Clinical background experience. Minimum of 5 years of pharmaceutical industry experience and clinical research experience. Headache or CNS and Medical Affairs experience preferable. Experienced and adept at working collaboratively across different cross-functional teams such as commercial, R&D, health outcomes, regulatory, pharmacovigilance and compliance. Leadership experience in developing strategy and executing medical plans, and in building professional external expert networks. Broad knowledge of drug development, clinical trial design, regulatory requirements, business development and life cycle management
Capability
Demonstrated ability to network and develop relationships within industry and academia
Ability to successfully manage in cross-functional settings e.g. a scientific and commercially-focused environment
Strategic thinker and has a creative, solution-oriented style; flexible and able to work in a fast-paced, rapidly changing environment on multiple projects with aggressive deadlines; team-oriented energetic and passionate about making a difference
Has a strong work ethics and character is of the highest integrity, including strong ethical and scientific standards

Global Medical Affairs Director Resume Examples & Samples

Good understanding of the pharmaceutical business
Skilled in working in cross-functional and cross-regional teams
Establishes and communicates high working standards, promotes a culture of performance, innovation, constructive challenge, team spirit and accountability within Medical Affairs
Understands the global and local needs and dynamics within companies
Ability to develop and maintain strong relationships with external experts within TA
Demonstrated evidence for the capacity to lead and manage, a group of professionals (physicians and/or scientists)
Experience in designing, planning and executing medical affairs activities, comprising studies
Familiarity with clinical trial processes across different phases of development and resolving clinical trial-related issues
Experience in writing or reviewing scientific communications
Cognizant of local reimbursement processes, of product-specific pricing issues and understanding of required medical contribution to pricing/reimbursement dossiers
Track record in effectively managing risk and compliance Excellent communication, interpersonal, and negotiation skills
Fluent in English, verbal and written communication; other languages spoken a plus
Ability to travel away from the office to the degree appropriate to support the business of the area or team

Global Medical Affairs Director Resume Examples & Samples

A minimum of an RN degree (or equivalent degree) is required
A PhD, PharmD, MD, Doctor of Optometry, or equivalent degree is preferred
A minimum of 3 years of clinical and/or pharmaceutical experience in retinal disease is required
A minimum of 3 years of active involvement within the global retinal community is required
A minimum of 5 years of combined relevant experience in a medical/clinical environment and/or scientific function in the pharmaceutical and/or medical device industry is required
A minimum of 3 years of experience in the Medical Affairs environment is preferred
A demonstrated track record leading or working as a core member of highly matrixed, cross-functional team is required
Previous experience and proven ability to act as a medical spokesperson for external audiences is required
Strong experience developing and managing strategic relationships with medical experts/opinion leaders is required
This position will be located in Horsham, PA, Spring House, PA, or Titusville, NJ and will require up to 35% domestic and international travelMedical Affairs

Senior Director Global Medical Affairs Neurology Resume Examples & Samples

M.D., D.O., PhD or equivalent degree, preferably with experience in the areas of Neurology
US Board certified Neurologist preferred
Director ( 7-10 years) / Sr. Director (11+ years) in the pharma/biopharma industry and a minimum 3 years of experience in the therapeutic area is required
Excellent written and oral communication skills, including strong formal presentation skills
Strong interpersonal skills commensurate with the need to work closely with both external physicians/scientists and numerous in-house support groups
Ability to maintain the highest degree of confidentiality and integrity, represent the company’s high ethics, moral behavior, and professionalism
Ability to work under pressure, and to maintain scientific excellence within timelines
Demonstrated ability to maintain scientific credibility while executing the Medical Affairs plan, and to communicate scientific results and effectively respond to data queries from customers and/or consultants
Knowledge of scientific methods, research design and medical practices and procedures that would be acquired through research, clinical experience or clinical research studies
Basic knowledge and appropriate application of biostatistics
Ability to travel (frequent travel will be required)
Proficient in Microsoft Office applications including Word, Power Point and Outlook

Global Medical Affairs Resume Examples & Samples

A core member of the Pancreatic Cancer Disease Strategy Team (DST) which is responsible for
Board Certified Oncologist; MD/PhD preferred
Laboratory expert in pancreatic cancer: deep understanding of the molecular and immunological aspects of pancreatic cancer. Laboratory research in pancreatic cancer extending beyond post-doctoral fellowship preferred
Expert in Disease Area with at least 5-7 years of clinical experience in the disease area, and good understanding of KOL landscape
At least 7 years of clinical trial experience, either in academics, cooperative groups, or industry
Intimate working knowledge of the role of Medical Affairs within industry
Strong interpersonal skills and demonstrated success achieving results through cross-functional matrix teams
Good understanding of GCP, statistics, and clinical trial designs
Good understanding of commercial drivers of success
Experience in and/or accountability for multiple geographies preferred
10+ years of experience academia/industry
Travel: Must be able to travel internationally and within US on a frequent basis. Anticipate approximately 30% travel

Head of Global Medical Affairs & Integrity Practice Resume Examples & Samples

Develop, implement and lead the performance of key governance areas, their measurement, management, training and process adaptations to achieve the highest standards
Development and implementation (in partnership with PVUs PVOps and PVF) of standard frameworks for all medical affairs activities in scope, while establishing boundaries that allow diversification of activities within allowable frameworks. Simultaneously the role is accountable for driving innovative approaches based upon direct knowledge and understanding, through network intelligence, of the current and future drivers of patient value. The role is expected to lead the piloting of the implementation and rolling out of targeted solutions based upon rigorous evaluation and determination of delivered patient value. Targeted solution development to be based upon a deep and shared understanding of the therapeutic, geographic, and governance requirements and drivers of value within UCB’s and its partners’ footprints
Awareness and oversight of implementation of relevant Codes and standards throughout UCB to ensure appropriate governance and compliance in (but not limited to) promotional and allied activities, transparency and disclosure, medical information and safety reporting
In partnership with Clinical Development, utilise environmental intelligence and evidence requirements to influence Integrated Evidence Plans and Clinical Development Plans to ensure the derivation of evidence as early as possible within the development phase to enhance the patient relevance of our development activities and our informed pipeline decision making as a result. Additionally, these activities are expected to improve the probability of regulatory approval through improving the patient (and thus payer) relevance or our programmes and reduce the time between approval and access
Develops and explores a wide network to build intelligence and awareness of future trends to positively influence them to deliver patient value
Works closely with PVU, PVO, PVF colleagues to develop a shared accountability for each other’s successes through a deep understanding of shared objectives, behaviours and deliverables
Provides leadership, mentoring, supervision and over-sight for Medical Affairs and Integrity activities, including conjointly agreeing strategy and implementation plans that lead to delivery of UCB’s Strategic Plan. To effectively manage allocated budget, standard operating procedures, talent and professional development. Ensures close and effective collaboration across all Medical PVU/PVO Leaders, including Patient Value Functions, such as IT, Business Development, Legal and Compliance to ensure alignment with corporate objectives and minimisation of overlap
PharmD, PhD, or Medical Degree
Substantial Medical Affairs experience in more than one specific area. Ideally with a blend of field, affiliate, regional or global leadership and central governance experience
Essential: demonstrable experience of governance activities and their pragmatic implementation in an integrity framework
Excellent interpersonal and communication (verbal and written) skills
Demonstrable evidence of successful implementation of innovative externally relevant solutions
Understanding of regional and global healthcare ecosystems and the developing stakeholder influencing map
Experience of working within and leading matrix teams with evidence of success in co-creating and implementing innovative governance programmes and externally focused access solutions
Comfortable working with complexity in a fluid environment
Experience in KPI and metric development, deployment and CAPA oversight
Competencies in the Digital area / Social Media area of your expertise are a plus
Flexible and inspirational leadership that values and demonstrates partnership and humility, with an ability to articulate a clear vision that links all aspects of medical affairs work, integrity activities and that of its partners
Strong cross-functional collaboration skills
Strong project management skills, including projects managed and delivered via a matrix organization, across affiliates
Budget planning and management

Senior Global Medical Affairs Leader Resume Examples & Samples

Provide a coordinated approach to building AstraZeneca's medical leadership in hematology, and deliver medical insight into the development and execution of an overall hematology disease area strategy
Oversee and support the development and execution of the asset specific integrated medical plans (evidence generation and scientific communications), including global external experts, diagnostics, and patient centric activities
Partner closely with colleagues in the Markets, Development, early research (MedImmune & Innovative Medicines, Regulatory, Commercial, Access, Health Outcomes, and other key functions). Help build alignment on key initiatives, including optimal approach to data generation, communication, and supporting access
Provide oversight of the GMA hematology team and GMT(s) and manage appropriate involvement of prioritized market teams to ensure that market insights are used to inform product development and Global deliverables
Interface with internal and external stakeholders to enhance the scientific and clinical understanding of the brand

Global Medical Affairs Leader, Immuno Resume Examples & Samples

Provide a coordinated approach to building Astra Zeneca's medical leadership in Immuno-Oncology (IO), and deliver medical insight into the development and execution of an IO strategy
Oversee and support the development and execution of integrated medical plans (evidence generation and scientific communications), including global external experts, diagnostics and patient centric activities
Partner closely with colleagues in the Markets, Global Medicines Development (GMD), early research (MedImmune and Innovative Medicines & Early Development (IMED), Regulatory, Commercial, Access, Health Outcomes and other key functions, and help build alignment on key initiatives including optimal approach to data generation, communication and supporting access
Provide oversight of the assigned indication/tumor type and manage appropriate involvement of prioritized market teams to ensure that market insights are used to inform product development and Global deliverables
To interface with internal and external stakeholders to enhance the scientific and clinical understanding of the brand
Responsible for the co-ordination of Medical Affairs activities including
Advanced scientific degree (M.D, PhD, PharmD)
Medical Affairs experience (2+ yr), preferably with country launch experience. At least 4+ years total of pharmaceutical or relevant medical/clinical experience minimum
Understanding of drug development and commercialization processes including understanding of outcomes research /payer access issues
Proven ability to generate, analyze and interpret clinical trial and published data
Ability to manage multiple projects and products simultaneously to ensure timely, on-target and within budget accomplishment of tasks
The candidate is expected to have strong project management skills and ability to work effectively with cross-functional teams including development, marketing, and health outcomes
Good communication and presentation skills in English
Oncology experience

Global Medical Affairs Lead-oncology Resume Examples & Samples

Relevant advanced scientific or medical degree of appropriate certification
Mandatory practical, working knowledge of Medical Affairs and Disease Area - Oncology
Experience with global KOL engagement Patient-centered but commercially aware, values driven approach
Ability to translate clinical data into a strategic medical plan
Strong verbal and written communication skills in English with ability to present in front of external and internal stakeholders
Presentation and influencing/negotiation skills
MD and /or PhD

Global Medical Affairs Leader Resume Examples & Samples

Plans, coordinates and implements the Medical Affairs Plan to enhance and forward the understanding of Ventana products, specific to assigned Lifecycle, amongst healthcare professionals in collaboration and alignment with all stakeholders; coordinates budget with Lifecycle Team and International Business Team process
Provides Medical and Scientific Affairs input into overall Business plan
Ensures appropriate resource planning and execution in accordance with the plan within budget; identifies areas of need and proactively addresses operational gaps
Provides oversight for direct reports, including setting of individual objectives and performance evaluation on an ongoing basis and at regular review sessions, and talent development
Develops and executes study protocols for Roche Sponsored studies, in collaboration with key stakeholders, to produce high quality data to support the goals of the strategic Medical Affairs Plan
Evaluates Investigator Initiated Studies (IIS), participate in Clinical Trials Review Process and be accountable for activities related to approved IISs
Generates medical and scientific information materials; develops and executes publications plan; authors and reviews of scientific publications, including abstracts, posters, manuscripts and whitepapers
Plans, develops, and generates content and delivery of internal and external scientific and educational programs
Contributes to, reviews and approves medical/scientific communications including marketing materials and participates in Promotional and Scientific Content Approval Processes
Establishes and maintains ongoing long-term collaborative peer-to-peer relationships with Global key thought leaders and leads Global Key Opinion Leader activities including Medical Advisory Boards; aligns with IBT and Regions to ensure transparency regarding KOL activities
Leads Scientific Exchange activities, including responding to unsolicited requests for information from healthcare professionals in accordance with all compliance regulations and policies
Serves as liaison for Medical and Scientific Affairs activities with Diagnostics Business Areas and Pharma Medical and Scientific partners for collaborative projects
Supports Regional Scientific Affairs and Customer Service Operations at high level of escalation to assist with customer interactions and trouble shooting
Maintains clinical, scientific and technical expertise in specific therapeutic areas; keeps abreast of the current literature, collects and communicates medical and scientific insights and intelligence relevant to Lifecycle and product portfolio

Regional Head-global Medical Affairs & Integrity Practice Resume Examples & Samples

Actively network and collaborate with a wide range of regional internal stakeholders to exchange insights on innovative Medical strategies for patient value creation (PVU, PVO, PVF, PVP)
Actively network and collaborate with a wide range of regional external stakeholders to exchange insights on innovative Medical strategies for patient value creation
Partner with CDMA to amplify and embed insights, developing “Industry Leading” Medical Affairs capabilities and Stakeholder Engagement strategies for each UCB region
Leverage best practices, tools, systems and resource sharing framework to drive synergies across UCB regions to support a culture of excellence in Medical Affairs
Support regional adoption and optimization of Medical PVP initiatives and deliverables
Dashboards and monitoring plans that assess impact on patient value and stakeholder satisfaction
Regional benchmarking and innovation pilot programs
Evaluation of appropriate, efficient and effective systems, tools and processes
Regional KPI, CRM, KOL medical plans and metrics
Collaborate with regional affiliates and IT to deliver metric reports
Analyze metrics and share with CDMA regional performance and impact metric trends
Excellence in core business capabilities, competencies and skills based on latest benchmarking, insights and stakeholder data
Provide coaching and mentoring to enhance pull through
A minimum of 8 years relevant Medical Affairs experience
Ability to synthesize and apply healthcare ecosystems knowledge of available medical resources
Knowledge of regional healthcare ecosystems and the stakeholders influencing decisions
Comfortable working in an ambiguous and fluid environment
Thorough understanding of the regulatory and compliance guidelines relevant to the pharmaceutical industry
Comfortable arbitrating risk tolerance across functional groups
Experience in developing strategies based on benchmarking and stakeholder insights
Experience in or working closely with strategic planning
Experience in scorecard and impact metric development and deployment
Strong working knowledge of the entire Microsoft Office Suite (Word, PowerPoint, Excel, Access), SharePoint, and relevant software solutions
Negotiation, influencing, and conflict resolution
Strong project management skills, including projects managed via a matrix organization, across affiliates
Vendor sourcing and management

Clinical Trial Head-oncology Global Medical Affairs Resume Examples & Samples

Ability to manage phase I-IV clinical trials including EAP, Compassionate Use and non-interventional studies. Accountable for the writing of clinical protocols and related documents in collaboration with the GBMD,: lead the clinical trial protocol development process; contribute to the medical/scientific input given for the development of trial-related documents and processes which reside in other line functions; obtain approval from internal review boards. Collaborate with the Medical Directors and Advisors of the major Novartis local medical organizations to ensure country feedback is adequately integrated into protocol
In collaboration with the GBMD, lead the clinical trial data ongoing medical/scientific review, final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations
≥ 5 years technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization
Demonstrate effective Project Management skills as well as ability to prioritize based on business need
Thorough knowledge of Good Clinical Practice and clinical trial design. Immediate statistical and regulatory process knowledge required. Experience with complex or randomized studies
Working knowledge hematology/oncology/endocrinology knowledge of therapeutic area is preferred

Senior Global Medical Affairs Physician MD Resume Examples & Samples

Senior Global Medical Affairs Physician’s primary purpose is to provide strategic medical direction and leadership to ensure the successful global commercialization and medical development of Bayer in products in oncology
Senior medical doctors (physicians) in these positions manage oncology Global Medical Affairs physicians, and provide strategic medical direction and governance to the medical studies and other activity undertaken by the oncology Business Unit, TLT and the oncology global brand teams to ensure global commercial success of the oncology portfolio (Nexavar and hematology oncology products)
Provide the medical strategy for global phase IV medical affairs studies to support the commercial success of Bayer oncology products
Plans and coordinates the design, conduct, analysis, reporting and publication of Bayer oncology global phase IV medical affairs studies
Provides strategic review of oncology Investigator Initiated Studies and Post Marketing Surveillance Studies
Ensures all regional studies are consistent with agreed global medical strategy
Provide medical expertise and insight on commercial issues through membership of the oncology global brand teams (GBTS)
Plans and conducts scientific advisory boards with key opinion leaders and external customers
Represents Bayer viewpoint on products to key opinion leaders, scientific advisors, and health authorities, as well to other external stakeholders
Provides medical affairs input to global clinical development programs
Provides medical probability of success and feasibility assessments to global marketing colleagues in relation to Bayer products
Provide medical review of promotional material from the Global Brand Team for global use e.g. product monographs, brochures, press releases, Q&A’s, field communications
Lead medical affairs activity connected to the Global Brand Team scientific publication process, global KOL development programs and global medical congress activity
Provide medical affairs input to core labeling and pharmacovigilance documents for marketed products (e.g. risk management plans and benefit analysis for risk-benefit assessments)
Establish and lead medical affairs matrix teams for global brands in oncology
Medical Doctor (physician) with advanced postgraduate medical training/experience (for the hematology pipeline position, an md is preferred but not essential)
A minimum of 8-10 years’ experience in clinical development and/or medical affairs function of a global healthcare organization or equivalent at regional or country level disease or therapeutic area knowledge in both existing drugs and new fields of exploration
Understanding of drug development process over different stages
Experience of developing and delivering presentations and publications in English
A strong global mindset
Understanding of global regulations and guidelines
Experience of effectively managing risk and compliance issues
Experience of managing teams across cultures and geographies
Experience of participating in cross-functional teams
Experience of working across and building effective working
Relationships between functions
Proven record of relationship building, both internally and externally to the organization
Fluency in English plus the local language is required
For the hematology pipeline position, an md is preferred but not essential

Senior Manager Global Medical Affairs Aspirin Resume Examples & Samples

Under the direction of the Director, Global Medical Affairs & Clinical Development the Senior Manager Global Medical Affairs will assist to set strategy and implement objectives for development of global new product development programs
He/she will assist to provide medical guidance and category knowledge to our existing brand teams globally
Additionally, he/she will assist to serve as the scientific medical guide on new product clinical development, launches, claims, and indications
He/she will assess potential product/claim plans and provide scientific medical opinion to the Business Unit and Portfolio Management Teams
He/she is responsible for assisting to ensure the active support of internal and external functions required for brand positioning
He/she is responsible for Health Authority activities
He/she has to give medical governance to country medical departments and country marketing and regulatory as needed
The function will also encompass the management of point of view development for publication across business units in conjunction with US and global category functions
He/she will interpret scientific data from the literature and/or from clinical studies to assist in product development strategies, as well as to ensure the accuracy of advertising claims and other promotional materials and represents medical function in the LMR process
The incumbent must have the ability to gain customer (internal and external) feedback, understand marketing and strategic planning techniques, and provide medical and scientific data interpretation in the assigned categories
He/she must be able to prioritize and work effectively in a constantly changing environment and to adjust their work according to direction provided by the Director of Global Medical Affairs & Clinical Development
He/she must carry out this role in accordance with departmental SOPs, Bayer corporate policy, and other legal & regulatory requirements
Assist in providing strategic planning and implementation of clinical and health authority registration programs in support of all therapeutic areas globally including existing, line extension and new products
Assist in providing scientific/medical guidance and category knowledge to support existing and new products point of view development
Work closely with the commercial colleagues to gain alignment with development plans
Gain understanding of clinical study publication process and take these studies from field to journal visibility
Interpretation of clinical studies data and medical literature search material relevant to categories
Build relationships with key opinion leaders, societies and institutions while working with emerging scientific discovery to keep the company ahead of the most recently published literature in various categories
Support and substantiate advertising claims, promotional materials and participate at review/approval process
Supports management in merger and acquisition and due diligence activities
Supports management in medical governance activities
An advanced degree in related scientific field with PharmD, PhD or MD with 5-7 years of relevant clinical, clinical research, and/or development activities or medical affairs or related businesses; or an MS with 7-9 years of relevant clinical, clinical research, and/or development activities or medical affairs or related businesses
Ability to interact with and influence people at all levels within Bayer
Thorough knowledge of scientific/medical information, thought leader development, clinical knowledge
Excellent interpersonal communication and presentation skills, including the ability to network, are necessary to present critical medical and scientific information to internal departments, and to positively interact with external customers, medical thought leaders, and academic communities
Experience with working in the pharmaceutical industry

Finance Lead, Global Medical Affairs Resume Examples & Samples

Bachelor’s s degree with 8 years of experience in Finance / Controlling / Accounting. Master’s degree preferred
Strong accounting skills and experience and ability to drive Financial monthly closing activity
Advanced knowledge of Excel and Powerpoint, SAP preferred
Experience in the Pharmaceutical/Biotech Industry
Mgmt. Reporting and Forecasting tool experience: IBM Cognos TM1, Hyperion/Essbase, Qlikview

Global Medical Affairs Leader Resume Examples & Samples

Lead on the situational assessment and the global product strategy development including harmonization of activities involving KOLs
Develop in-year global medical strategy, Implementation and budget plan for global initiatives
Provide medical strategic recommendation for in-line life cycle management (LCM) and late phase pipeline programs
Develop Phase 3b/4 and ISR evidence generation strategy for late phase pipeline and in-line TA programs
Develop and oversee clinical study design (non-registration phase IIIb/IV, registries, outcomes research etc.) for late phase pipeline and in-line TA programs in close collaboration with relevant functions
Provide medical review and ensure alignment with TA strategy of Investigator sponsored research (ISR) proposals
Provide clear strategic guidance to scientific communication, internal medical training, external medical education (CME, Symposia, medical education), Medical info, PEVT teams in developing functional plans supporting global medical strategy
Develop medically appropriate commercial strategy/tactic, planning and execution
Provide global medical guidance to country medical teams in developing country medical plans aligned with global medical strategy
Collaborate with country medical TA lead to ensure local activities are aligned with global medical strategy and that Global Medical is sufficiently aware of country insights and needs. Alignment among Global and Country Medical Plans, adjust if needed
Monitor team performance in terms of goals and delivery of global medical plans
Responsible for development and execution of major registration LCM program and geographically expansion strategy
Proven ability to manage budget and resources
Ability to build partnership access between HQ and affiliates
Flexibility and ability to adapt to changing conditions
Travel required up to 25%

Global Medical Affairs Resume Examples & Samples

Support the Head of Global Medical Affairs Dupilumab Atopic Dermatitis in the build and execution of Global Med Affairs strategy
Build and execute the Life Cycle management for Dupilumab Atopic Dermatitis including pediatric indication; define and prioritize the future needs including new study ideas and tactics to prioritize the best areas for clinical trial investment
Collaborate with alliance partners at Regeneron: take a team-oriented approach to making sure strategy is clearly defined and consistent with relevant stakeholders in clinical development and commercial teams
Coordinate data gap analyses across the Regions and countries
Establish data generation GMA plans and supervise the implementation
Lead and supervise analyses from the development program dupilumab for additional publications
Supervise physician/scientist in charge of the execution of the GMA LCM and data generation
Lead advisory boards or roundtables for anti-IL-4/IL-13 in Atopic Dermatitis and gain strategic insights for medical, scientific, and development strategy
Ensure the scientific integrity of sponsored and supported research, information, and relationships with healthcare providers and patient advocacy groups
Ensure a patient-centric approach to development of medical strategy both for product and device development as well as possible services which can enhance the value proposition of the product; Provide relevant feedback to market access teams to ensure optimal pricing and reimbursement strategy and inclusion of relevant endpoints in clinical trials
Travel required, comprising approximately 30%
Minimum 8 years’ experience in industry medical affairs
Prior experience in a Global or at least Regional medical affairs role
Prior experience in Immunology/Immuno inflammation Medical affairs Life Cycle management
Prior experience in managing a team
Able to work on projects in coordination with the Alliance partner and establish excellent working relationships and credibility

Global Medical Affairs Resume Examples & Samples

Drive the roadmap and adoption of product releases by engaging with business and IT leaders within in the organization and vendor product teams
Act as the Primary Architect for the design and implementation of all SaaS solutions
Provide consultative support, define technical solutions and evangelize functional and technical capabilities
Identify potential risks and impact on operations associated with new solutions
Establish process for the use of SaaS Architecture frameworks and tools
Participate in Architecture Reviews throughout the project lifecycle
Manage SaaS governance and vendor performance
Facilitate, develop, review and maintain the definition and implementation of standards, methodologies, and best practices that guide the design of SaaS technology solutions
Facilitate and Develop Innovative POCs (proof of concept) exercises to demonstrate feasibility in order to refine and also showcase capabilities of new and existing SaaS Solutions
Understand security best practices, policies and standards to design a highly secure internal and external SaaS Architecture
Facilitate, communicate, collaborate and persuade others in defining adopting, and implementing a coherent technical architecture for all SaaS Solutions
Act as expert point of escalation for all issues
Bachelor’s degree and 8+ years of experience in IT working for or consulting to large, F500 companies. Healthcare and Pharmaceutical R&D experience preferred. MBA or Masters in Information Technology desired
8+ years of experience in increasing levels of responsibility developing solutions & applications with at least 3+ years managing SAAS Solutions
2+ years of implementation experience, including development, across the full software development lifecycle
5+ year of experience in an Architect Role
Possess detailed knowledge and awareness of emerging trends and technologies within SAAS Architecture
Outstanding leadership and motivational skills to ensure that technology solutions continuously meet the evolving needs of the business
Custom development experience and integration with other enterprise applications
Experience with multiple, complex and at least one large SAAS implementation project involving multiple releases, change management process and/or multi location deployment
Ability to understand organizational goals and business requirements and translate them into architectural solutions
Understanding of best practices and design trade-offs, with the ability to communicate design choices
Awareness of mobile solutions and considerations
Awareness of common third-party solution providers
Knowledge of internet and cloud architecture paradigms
Experience with Veeva and/or salesforce.com and/or force.com development
Experience in designing/developing Web Services/Rest API to interface with other systems
Experience with Enterprise Integration and ETL tools
Experience with JavaScript, .net, Java
Understanding of data, network and single sign on technologies
Experience in providing guidance on technology solutions both verbally and through the preparation of written materials in order to build relationships, influence and negotiate
Motivated by the long term. Results driven, ensuring short-term goals are achieved that support long-term initiatives with an appropriate sense of urgency
Experience working in an IT environment supporting Global Medical Affairs is a plus

Head of Global Medical Affairs Bone Resume Examples & Samples

Minimum 5 - 7 years of experience in medical affairs with a track record of connecting the scientific data to patients and bringing patient insights back to scientists and business
Track record of connecting and developing trustful relationships with internal and external stakeholders to accelerate business achievements and leveraging diversity to improve outcomes
Ability to bridge strategy and execution within a Medical Affairs platform

Global Medical Affairs Lead Resume Examples & Samples

Lead the Global Medical (Product) team through direct and indirect reporting relationships
Contribute to global product strategy through deep understanding of the medical environment globally through integration of country and regional insights, and engagement of external experts
Develop and lead the execution of global medical affairs strategy, including external stakeholder management, scientific communications, evidence generation and medical education strategy
Develop and lead execution of a global medical communication strategy including
5+ years of patient clinical experience
10+ years of medical affairs experience in the pharma/biotech industry
3+ years of scientific or medical research

VP, Global Medical Affairs Resume Examples & Samples

Develop and implement strategically–aligned goals and objectives, operating procedures, and performance metrics for the medical affairs group
Provide expert advice and medical/scientific inputs to Marketing in support of the global brand strategy for commercial portfolio
Coach, manage, mentor and lead medical affairs teams, providing individual and team development and ensuring objectives are met and all teams are operating within corporate compliance guidelines
Manage distribution partner relationships to ensure programs and objectives are met and fully compliant
Oversee all corporate medical education activities including speaker training, educational outreach programs, etc
Develop relationships with the relevant external medical communities and establish a presence as a peer and as an educational and clinical/non-clinical research resource with clinicians and scientists, particularly including key medical and scientific opinion leaders
Direct operations and compliance for global expanded access programs
Serve as an advisor on clinical and scientific issues to other departments in the company as appropriate
Lead various related internal and external activities as designated by manager
Lead phase IV programs, including Investigator Sponsored Study Program and company-wide publications planning
Manage overall budget for GMA functions and programs
MD with board certification in cardiology, pulmonology, oncology or other relevant specialty preferred
Previous experience managing a global medical affairs function and/or demonstrated success implementing Medical Affairs program(s) at a biotech/small pharma strongly preferred
Product/Device pre-launch/successful launch experience strongly preferred
Proven exemplary team building, management and leadership skills
Record of accomplishment and increasing responsibility in scientific, clinical and/or pharmaceutical industry setting
Demonstrated knowledge of FDA requirements, industry compliance, ISS design and strategies, commercial and publication strategy and medical information processes
Working knowledge of current legal and promotional regulatory requirements, demonstrated appreciation of the global compliance landscape
Ability to interact and communication with a high degree of professionalism and scientific credibility to the Thought Leader community
Ability to establish strong working relationships with a diverse range of internal and external stakeholders to ensure achievement of corporate objectives
Demonstrated ability to lead and influence in a highly cross-functional environment
Ability to travel 50% +
Microsoft SharePoint experience is preferred
High degree of self-motivation

Analytics Director, Global Medical Affairs Resume Examples & Samples

2) Is the incumbent in charge of leading other Sanofi employees? No
At least 7 years’ experience in Pharmaceutical or related industry with demonstrated ability to lead and perform analyses on key organizational performance, financial and operational data / metrics to drive meaningful improvement to organizational performance
Exceptional verbal and visual communication skills to communicate complex quantitative analysis in a clear, precise, and actionable manner to a wide variety of audiences
Ability to collaborate in a rapidly evolving environment
Ability to interact effectively with business stakeholders
Strong background in bio-medical science, or experience working in a scientific/medical environment preferred
Advanced proficiency in data manipulation and presentation (including Excel®, Qlikview or other Visualization tools) and strong presentation skills (including PowerPoint®) required

Global Medical Affairs Associate Resume Examples & Samples

1) MARC (Medical Affairs Research Committee) Operational Lead
Lead study start up process for ISS (perform, document and track training)
Assess Fair Market Value for new ISS concepts
Draft initial contract and budget milestones / CAF submission and pull-through; liaise with legal and site
Manage study milestone and budget tracker
Develop process for continual audit and maintenance of ISS files
Manage ISS drug supply
Maintain reasonable strategic, product, and disease state knowledge associated with therapeutic areas under study
2) Grants Review Committee Manager
Manage grant review process, maintaining and updating Grant submission portal
Verify that submissions are complete and ready for review; liaise with Legal, Compliance, Accounts Payable and Finance to manage grant request and requestors providing guidance about the submission and review process
Generate contracts for approved grants and execute payments in a timely manner
Document/track budgetary expenditures
3) Publication Planning
Maintain publication tracking database
Develop and run publication metrics as required (quarterly and yearly summaries)
Manage publication review process
Develop process for continual audit and maintenance of all publication files
4) Medical Affairs Scientific Advisory Boards
Coordinate planning and logistics of Med Affairs Ad Boards
Interface with meeting management company
Lead management, set-up, invitations, and contracts
5) Strategic Trial Initiatives
Liaise with contract research organization, research vendors and/or clinical sites legal to manage contract process for special projects/studies
Lead study start up and monitoring activities as needed
Manage logistics including purchase orders and submitting invoices
High level of proficiency using MS Office (Word/Excel/PowerPoint/Outlook)
Microsoft SharePoint and Veeva experience is preferred
Ability to initiate and manage day-to-day tasks effectively

Global Medical Affairs Director Resume Examples & Samples

Supports the Global initiative for MS thought leader relationship-building and through these relationships gains meaningful expert insights that influence priority areas for franchise medical affairs strategy
Contributes to the strategy of the franchise, taking into account Sanofi Genzyme (SG) commitment to the Multiple Sclerosis (MS) community to optimize franchise success in a highly competitive environment to optimize franchise success in a highly competitive environment, in close collaboration with Global Franchise Marketing
Defines and develops KOL management plan with top 20 KOLs, ensuring recommendations are acknowledged in our plans; develops best knowledge of the franchise with top 60 KOLs to ensure accurate communication
Works closely with other functional areas within the MS Business Unit (BU) in developing the annual MS Franchise Brand Plan, the Strategic and International Advisory Boards, Global Congress Symposia, Global Internal meetings, and the Global Medical Affairs Summit, to build foundation and differentiation of the franchise
Contributes to the definition of the MS Franchise communication strategy
Ensures internal knowledge on key projects by communicating on activities, key results, project updates; as well as external meetings as close partner to top KOLs
Works closely with Agencies for all activities which are outsourced, together with Purchasing, Controlling, etc; has responsibility for the projects financial management including budget planning and preparation of monthly reports
Marketing support including customer meetings, presentations, promotional material, and representative training in relation with the projects
Provides medical input in to different initiatives/projects (e.g. Marketing, Market Access, HEOR)
Liaises with the MS Global Brand Leads and Medical Directors as well as the MS Regional Medical Directors to ensure fluid scientific communication, to satisfy medical needs, to contribute to specific projects, and to support medical education
Provides quality clinical input, as needed, into specific data sets, including those to be submitted to Price & Reimbursement boards, to assure the alignment with the MS franchise strategy and goals and ultimately serve the MS community and patient access in a timely manner
5 or more years of pharmaceutical experience in Medical Affairs activities at global, regional or country level or other relevant experience that would substitute for this
Knowledge expertise in the field of MS preferred,
Ability to think strategically and work independently in a cross-functional matrix. Ability to make effective decisions even in the absence of complete information and when under pressure, and to manage several projects simultaneously,
Excellent interpersonal skills, matrix management, negotiation, and leadership skills
Proficiency in Microsoft Office applications (Word, Excel, PowerPoint)

Global Medical Affairs Lead Oncology Resume Examples & Samples

Ensure NHSc leadership in the Scientific Community by Liaising / Partnering with external Stakeholders (e.g. KOLs, experts, Scientific Associations and Patient Associations) and sharing within NHSc relevant insights gathered to inform development and commercialization
Deliver outstanding Medical Education by leading and delivering medical education to healthcare providers beyond nutrition specialist (peer-to-peer) and by training internal teams including medical liaison roles in the markets (train the trainers)
Provide clinical substantiation to equip the markets with actionable messaging including contribution to internal deliverables (Product Dossier, etc.)
Sculpt the publication plan, review and contribute the writing of publications
Assess need for additional evidence to meet patients and HCPs expectations
Provide recommendation on PhIV trial
Inform commercial strategy throughout product lifecycle to support adoption
Monitoring and communicating internally competitors’ activities
Experience from Medical and Scientific Affairs and/or clinical experience in the therapeutic areas assigned for more than 5 years
Experience in Life Science (Nutrition/Pharma/Food Technology) would be a plus
Market experience and/or Experience of working in an international & multicultural environment
Experience in technical / scientific writing and communication
Experience in using scientific and clinical data in a creative and competitive way and simplifying complex concepts and data from R&D to platform and external stakeholders
Strong scientific background, proven clinical experience and good skills to translate from science to clinical development
Fluent in English, any other language is an asset

Director, Global Medical Affairs, Immuno Resume Examples & Samples

Leading the medical affairs activities for immuno-oncology with focus on PD-1 inhibition
Providing relevant data evidence to ensure that the strategy is clearly defined and consistent with clinical development and commercial strategic objectives and activities for PD-1 inhibition
Ensuring that all Sanofi Oncology PD-1 product data generated by the company or investigator sponsored trials is publicly presented in an appropriate and timely fashion and in a fair and balanced manner
Representing the regions and bringing their perspectives to the appropriate issues at hand
Pro-actively providing guidance to marketing and sales teams
Identifying needs for post-marketing clinical trials and registries and overseeing their management and execution
Interacting with experts at medical meetings, advisory boards, and outreach meetings to represent Sanofi and strengthen its reputation in Oncology. Also, maintaining external orientation by participating actively in external Oncology events and activities. #LI-SA
Immuno-oncology treatment expertise
MD, Board Certification in Oncology/Hematology or Pediatric Oncology/Hematology
Industry experience in Medical Affairs is preferred
In-depth understanding of and proven success in how to conceptualize, design, and conduct complex, global clinical trials
Broad and formal leadership experience, including excellent “leadership presence” to represent Medical Affairs within the company, to other functions, and to leaders at every level
Excellent skills working with experts from other functions and countries and influencing decision making without authority in a complex and matrix environment
High energy and an absolute commitment to a culture that operates with high ethical standards and strives to exceed all goals and objectives
Comfort operating in a consensus building role but also able to make specific recommendations and decisions and drive for implementation
Ability to inspire confidence – both internally and externally in Sanofi Oncology - by leading by example, demonstrating immuno-oncology expertise and collaborative behavior
Demonstrated ability to organize and lead expert Clinical Research Advisory Panels
Ability to understand and effectively communicate scientific and medical data results and information to internal and external stakeholders

Global Medical Affairs Operations Manager Resume Examples & Samples

Responsible for tracking and monitoring global medical affairs projects to ensure strategic focus and timely execution of deliverables. This includes managing timelines and deliverables, meeting management, and collaborating cross-functionally within the Takeda organization. Provide operational efficiencies by establishing process improvements, providing guidance and support to team members, and developing communication plans to engage key stakeholders and increase program-related communication across the organization
Support achievement of overarching program strategy, including identifying process improvements, instituting best practices, supporting development of tools, templates and reports, and documentation of lessons learned
Operate as internal consultant/partner to Medical Communications Head in the implementation of business processes and organizational initiatives
Project management of GMA-specific medical plan deliverables, including coordinating strategy/scope development, logistics and vendor management, and timeline management for KOL engagement events and symposia, as applicable
Develop and track project plans for KOL Engagement programs; provide routine updates to functional owner to ensure progress, resolution of issues, and communication of status
Provide guidance to vendors, drive timelines and processes, as well as updates to internal team regarding logistics for HCP meetings system entry and reconciliation
Support preparation of agendas, pre-meeting materials (ex. Briefing Documents), and meeting scheduling, as needed under supervision and direction of KOL Engagement Lead
Manage financial administration and documentation of project orders with external collaborators and consultants, and interact closely with Legal to develop contracts as needed for KOL engagement deliverables
Management of team sites and project tracking tools to maximize communication updates and ensure content maintenance in line with best practices; assess user feedback on an ongoing basis to prioritize future enhancements and improvement areas
Bachelor’s degree in business or related field
Proactive, self-motivated, and aware of larger business needs/implications
Experience with Microsoft Office software
Demonstrated ability to work both work independently and interdependently in cross-functional teams
Exceptional written and verbal communication skills, including the ability to clearly communicate business processes and solutions in person and over the phone
Ability to thrive in a fast-paced and evolving professional environment
Excellent prioritization, project management, and analytical skills

Director Global Medical Affairs Meningococcal Vaccines Resume Examples & Samples

M.D or Ph.D. (in life sciences, immunology, vaccinology, infectious diseases, public health and/or epidemiology)
Clear understanding of the ethical, regulatory, compliance and legal framework which underpins all of GSK’s interactions with the external environment; knowledge of the issues that face Pharma Industry with respect to interactions with External Experts
Local affiliate experience (LOC) is considered as an asset
M.D. (preferred)
Speciality in immunology, infectious medicine, epidemiology or other relevant specialty is considered an asset
English fluent. Other international languages are an asset

Global Medical Affairs Franchise Head Ophthalmology Resume Examples & Samples

Leads the Global Brand Medical Directors (GBMDs) within the Franchise to ensure that a comprehensive global scientific/medical affairs strategy and plan for each brand within the Franchise along the lifecycle is put in place – starting at Development Decision Point (DDP) – to clearly differentiate the value for the brands based on best outcomes for target patient segments
Represents GMA on the Franchise Leadership Team (FLT) to ensure all strategic & operational GMA decisions are accurately and optimally considered. Provide strategic guidance to ensure that GMA resources and activities within the Franchise are appropriately focused to deliver on strategic plans endorsed by the WWFLT
Accountable for the development and execution of the global medical affairs studies and communication/publication plans for all brands within the Franchise
Develops strong links and working relationships with key Regional Medical Leaders- these include the regional medical representatives to the FLT. In addition they must ensure that strong subject matter experts within GMA collaborate seamlessly with counterparts in Regions and Local CPOs
In close collaboration with the HEOR Franchise Heads, ensures that Health Economic and Patient Outcome perspectives are integrated into the product development strategy (in order to ensure the access to patient needs are captured and incorporated early enough in the clinical programs) and the medical affairs strategy, e.g. by helping to define appropriate end points for clinical development registration intent studies, designing the most relevant MA studies, and contribute to the most impactful patient outcome
Leads effective two way communication of Franchise GMA strategies and tactics to CPOs ensuring strategy alignment and ensures that regional insights are understood and captured within GMA plans
Supports successful global and regional/CPO execution in order to maximize the life-time value of each compound
Ensures that Franchise Scientific Operations requirements strategy is formulated, and operationalized through the appropriate GMA stakeholders
Create a highly influential medical and scientifically based platform, building global and local Medical Expert relationships for each brand within the Franchise
Ensures that the Global Head of GMA has updated information on all significant strategic and operational aspects of the Franchise GMA activities and is appropriately briefed for global meetings etc

Hematology / Oncology Global Medical Affairs Resume Examples & Samples

Ensure that the Global Hematology & Oncology community is supported and informed about the clinical and scientific basis for the therapeutic or clinical research use of our portfolio
Shape Celgene strategy in collaboration with Marketing, Clinical R&D and Regulatory Affairs
Conduct clinical research that answers critical questions about the best use of our products beyond the registration trials
Nurture relationships with Opinion Leaders and researchers in hematology and oncology
Science/research background
Basic knowledge of disease areas and medical terminology is a plus
Strong computer skills; proficiency with MS Office applications
Motivated and organized with ability to multi-task and prioritize effectively
Excellent communication, interpersonal and problem solving skills
Enthusiasm

Global Medical Affairs Leader, Acalabrutinib Resume Examples & Samples

Advanced scientific degree (M.D or PhD)
Hematology experience
2+ years Medical Affairs experience
4+ years pharmaceutical or related medical/clinical experience
Understanding of drug development and commercialization processes including understanding of outcomes research /payor access issues
Track record of successfully developing and executing Medical Plans both in terms of evidence generation, scientific communications and external expert engagements
Strong project management skills and ability to work effectively with cross functional teams including development, marketing, and health outcomes

Global Medical Affairs Resume Examples & Samples

Participate in 1:1 meetings with team members in other departments to be exposed to their functions and to appreciate the cross-functional relationship between Medical affairs and other functions, to include but not limited to (Minimum 3 to 6)
Assists Scientific director in making recommendations, taking action and providing Medical input into projects
Assists the Scientific director to interface with project team members including: Scientific communication, Marketing, Market access, Project leadership, Clinical development
Assists with preparation of key medical affairs documents and SharePoint sites
Assists with luspatercept tracker documents and entering data accurately and in a timely fashion
Assists with organization of medical affairs meetings for luspatercept strategy with cross-functional team members and capturing meeting minutes and action items
Responsible for completion of milestones associated with specific projects (as assigned)
Should maintain professionalism and confidentiality at all times and is required to sign a confidentiality agreement before engaging in internship activities
Should have a sufficient background of basic computer skills including Microsoft Office proficiency (e.g. Word, PowerPoint, Excel). Medical literature database searching skills and experience is a plus
Should be able to multi-task, prioritize assignments and be able to complete given tasks on a daily basis
Should exhibit excellent interpersonal skills (written and verbal) in order to work effectively and efficiently as part of a team

Head of Global Medical Affairs Resume Examples & Samples

Create and enable set up Therapeutic Area Strategy for the pipeline, work closely with Clinical Development and Medical Affairs stakeholders worldwide to synthesize insights and unmet medical needs into a cohesive strategy
Serve as a key member of the Medical Development Leadership Team
Assure alignment of Therapeutic Area Strategy with the overall clinical and commercial goals and objectives of the organizations
Drive creation and oversee execution of the following strategic global plans
Publication Plan in partnership with Clinical R&D
Open Research Questions in partnership with Project Leaders/Clinical Development teams
Global KOL Management Plan
Drive research strategy and implementation reflective of the Therapeutic Area Plan, optimize product profiles and assure appropriate access to patients world-wide for Spectrum products
Provide medical input for medical, scientific and promotional documents, and support of business development activities
Work with regional or local Medical Affairs Operations to assure that investigator-initiated Studies (IISs) are properly designed to address the most relevant research questions and needs
Support data analyses in collaboration with Clinical Research and Clinical Development colleagues
Lead registries and observational research (oversee protocol, case report form development, statistical analysis plan, data monitoring, data analysis, and publications)
Design, conduct, drive and report progress on all Medical Affairs’ studies
In regions without Medical Affairs leads, oversee conduct of IISs, from discussion of the concept to the approval process according to the IIS policy, ensure timely execution of contracts, support enrollment of the patients, and the reporting of results through abstracts, presentations, and manuscripts
Drive major international Congress Planning; strategically target relevant meetings and assure data for Spectrum products meets strategic objectives; assure excellent preparation for KOL management at specific Congresses
Contribute to the development of key publications (abstracts, manuscripts, posters, presentations, etc) and assure they are consistent with the Company’s Strategy as outlined in the Publication Plan; accountable for publication sign-off
Provide disease and product training in collaboration with key internal stakeholders
Coordinate and manage plan for patient access programs ATU, NPP, etc
Serve as key spokesperson to KOLs, collaborators, payors, and professional societies
Serve as a key member of the Business Development team, driving gap analysis, assessing opportunities, and advocating for specific projects that meet Company’ Strategy
Oversee the conduct of global Spectrum sponsored non-registration trials
Develop synopsis / protocols and assure Scientific Review Committee approval
Work in close collaboration with Clinical Operations to: select centers; develop Case Report Forms; drive enrollment to ensure timelines are met; support monitoring and oversee data cleaning; work with Biostats to oversee data analyses; supervise publication and presentation of study results at appropriate professional meetings; contribute to timely Clinical Study Report completion in collaboration with Medical Writing
Enable to lead and manage the entire Medical Affairs team and achieve both Company’s goals and team objectives on time
MD, or MD/PhD with background of training or practice in Hematology or Oncology
At least 7 years of pharmaceutical industry working experience in Medical Affairs with an intimate working knowledge of the managerial role in Medical Affairs
Passion to be the best and contribute as senior member of a growing company’s leadership team
Self-motivated and with a strong collaborative work ethic
Strong interpersonal skills and demonstrated success in Medical Affairs role in cross-functional matrix teams
Proven leadership and management skills; commitment to mentoring and talent development
Good understanding of the commercial drivers of product marketing success
Suitable clinical and medical skills for patient safety monitoring and safety assessment
Excellent oral and written communication skills, including presentations to large groups
Proven attention to detail and ability to understand, interpret and explain complex clinical data
Experience with designing and executing clinical studies and overseeing Investigator-initiated studies
Proven ability to “partner” successfully with the commercial organization
Good business instincts and a high ethical standard
Must be able to travel internationally and within the US on a frequent and business-needed basis; anticipate approximately 50% travel
Position is located in Irvine, CA

Associate Director Global Medical Affairs Resume Examples & Samples

Acts as Medical Publication Lead and drives the medical publication strategy for assigned therapeutic area and or products. The Medical Publication Lead is accountable for the delivery of the publication items and leads vendors in operationalizing the strategic publication plan, through building and leading a high-performing team. Communicates strategic and complex concepts in a simple manner to multidisciplinary teams. Ensures medical publications are delivered according to publication plan and predefined quality criteria. Plan and coordinate abstract submissions for major congresses. Identify new publication opportunities and collaborate with R&D functions to explore new content for publications
Identify and evaluate new opportunities of KOL interaction of assigned product area, develop and maintain contacts to KOLs and patient organizations. Devise and implement global KOL strategy
Responsible for evaluation of requests for investigator led studies and research collaborations. Support the review process for Interlaken Leadership Awards. Participate in ClinCom process for evaluation of investigator driven studies requests
Identify, develop and implement medical marketing initiatives (i.e. congress symposia, advisory boards, medical education/grant program). Contribute to development of medical and educational core promotional material and publications. Review medical content of promotional materials. Provide input into product development plans, in particular the clinical research program and design of clinical development plan (in collaboration with R&D)
Fill role of medical expert within commercial development, function as deputy for Med Affairs Director. Provide medical/scientific assessments of product opportunities in collaboration with R&D. Support training of staff of key countries as appropriate
Manage medical affairs budget for assigned projects

Director, Global Medical Affairs Resume Examples & Samples

Leading the medical affairs activities for isatuximab
Developing and executing a highly efficient, integrated global medical affairs/scientific strategy, including scientific evidence generation and scientific information exchange with all key stakeholders
Providing relevant data evidence to ensure that the strategy is clearly defined and consistent with clinical development and commercial strategic objectives and activities for multiple myeloma products and initiatives
Reviewing and approving medical and scientific content of Regulatory, Safety, Scientific Affairs, Medical Affairs, and Commercial
Ensuring that all data on Sanofi Oncology multiple myeloma products generated by the company or investigator sponsored trials is publicly presented in an appropriate and timely fashion and in a fair and balanced manner
Working closely with and influencing clinical development on all aspects, including study design, initiation, and monitoring
Providing leadership and strategic direction to local Product Leaders in interactions and communications with external customers, key organizations, and institutions
Representing the Regions and bringing their perspectives to the appropriate issues at hand
Leading the health economic team to prevent and/or address opportunities
Informing all major stakeholders of unmet needs and facilitating appropriate approaches to address them
Interacting with experts at medical meetings, advisory boards, and outreach meetings to represent Sanofi and strengthen its reputation in Hematology. Also, maintaining external orientation by participating actively in external Oncology events and activities
Multiple myeloma expertise
Sound scientific and clinical judgment, including in-depth understanding of the scientific method and clinical applications based on medical, scientific, and practical rationale
Demonstrated ability to inspire confidence while working effectively in a matrix environment
Ability to inspire confidence – both internally and externally in Sanofi Oncology - by leading by example, demonstrating multiple myeloma expertise, and demonstrating collaborative behavior
Excellent communication skills with the ability to build solid working relationships with the commercial organization, as well as negotiate and influence across cultures

Global Medical Affairs Medical Director, CVM Resume Examples & Samples

A minimum of a MD degree is required
Experience in diabetes therapeutic area is preferred
Prior experience in a global medical affairs role is preferred
A minimum of 5 years of combined relevant experience in a medical/clinical environment and/or scientific function in the pharmaceutical industry is required
A demonstrated track record leading highly matrixed, cross-functional work teams or similar experience comprised of high-level managers and executives is preferred
Global diabetes experience is preferred
Proven ability to partner cross culturally/regionally is preferred
In-depth knowledge of study methodology, study data reviews and analysis required
Excellent knowledge of study execution, benefit risk management and lifecycle management is preferred
Highly innovative with the ability to drive a complex and changing environment and effectively manage and resolve issues within the diabetes TA is preferred
Experience in developing and managing strategic relationships with medical experts/opinion leaders is required
This position will be located in Raritan, NJ and will require up to 30% domestic and international travel7911170413

Global Medical Affairs Resume Examples & Samples

Supports the GMAL in gathering medical insights from the Franchise LOCs and other key stakeholders to shape the integrated evidence strategy and plan
Leads aspects of Advisory Board design and discussion, as requested by the GMAL, ensuring compliance with SE governance and documentation requirements
Inputs to the design and delivery of phase 3b/ 4 studies, coordinating with relevant R&D technical experts e.g. Value Evidence Outcomes and Epidemiology as required
Supports preparation of materials for the governance review/ Brand Planning processes
Develops and reviews publications/ abstracts/ posters related to the product, key competitors and relevant disease area(s). Ensures the Data Dissemination Plan (DPP) is up to date
Supports the GMAL in communicating the clinical and market access data to the Franchise LOCs, ensuring a robust understanding of risk: benefit of our medicines
Enhances local tactical plans and shares best practices to support Launch Excellence

Assoc Dir Global Medical Affairs Resume Examples & Samples

Strong scientific background and knowledge of the pre clinical and clinical trial study development
Requires an understanding of the company's products, commercialization strategy, the competition, and the pharmaceutical industry in general
Ability to interpret scientific data and calculate potential commercial value and financial impact
Skilled in influencing people
Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
Demonstrated experience working with secondary data sources
Demonstrated ability to effectively communicate (written information and presentations) with internal and external parties

Global Medical Affairs Resume Examples & Samples

Support Directors Scientific Strategy and Training, or other functional directors on assigned programs in the examination of cross-project dependencies, risks, issues, requirements, and solutions
Coordination, prioritization, and tracking of multiple projects across the program in collaboration with other team members, including project managers or support staff that may be assigned to specific project tasks, and resolving any identified conflicts that may impact program success
Conduct and/or oversight of operational initiatives and processes used for training activities, management of project timelines, milestone tracking, and resolution of project issues
With the Directors Scientific Strategy and Training, sets program goals and determining resource requirements for defined activities, including setting priorities and long-term plans and schedules
Displays a growing ability and confidence in identifying program level risks and in developing contingency plans
Document that governance boards provide achievable objectives for the program and deliverables
Responsible for structuring and maintenance of project history files
Execute change management at the program level as required by internal or external environmental or strategic shifts
Delineate business rules as needed for efficient and clear management of applicable business systems
Manage the planning, operational, and reporting logistics of the GMST and/or other cross-functional meetings, including the planning of appropriate meeting schedules, communication of meeting plans to global team members, facilitation of meetings, distribution of advance-meeting materials, capture of deliverables, distribution of minutes, archival of materials
Demonstrate leadership in the communication with global partners and ability to persuade team members in areas of technical expertise
Ensure personal and team compliance with all relevant policies, SOPs, regulations and Codes of Conduct
Support Directors Scientific Strategy and Training in continuous improvement of processes and supporting tools to determine best practices and appropriate resource needs, including budget, tools, and personnel
Provide regular project status update reports to Scientific Strategy and Training team and senior management, including information from Finance and others as required that highlights status against key milestones, issues, risks and mitigations impacting performance, schedule and cost
Coordinate vendors, incl. communication of expectations and timelines and ensuring high-quality deliverables are received on time in close cooperation with Project Managers or Directors of Scientific Strategy and Training
May be responsible for contract, invoice and budget management with external consultants and service providers
Responsible for building quality relationships with key stakeholders that result in valued and trusted partnerships
Bachelor’s degree in science (preferably in life science) or business-related field
Minimum 7 years of project management experience, preferably in the area of medical affairs or clinical development within the pharmaceutical/biomedical industry, including at least 3 years leading projects within the pharmaceutical/biomedical industry within a multi-disciplinary global environment
2 years experience managing complex budgets for multiple projects
Experience supervising vendors
Proven ability to collaborate effectively with internal as well as with external business partners, and foster trust among global colleagues working in a matrix environment
Ability to work on cross-functional teams and to prioritize operational needs effectively
Ability to anticipate problems, to appropriately raise issues to management, to bring an insightful approach to problem solving, and to communicate issues to stakeholders in a timely, mature, and professional manner
Strong organizational skills – ability to manage multiple tasks of varied complexity simultaneously
Proficiency with MS suite tools, including Office and Project
Ability to develop, articulate and establish processes with cross functional impact
Demonstrate a high degree of self-awareness, self-motivation, initiative, and attention to detail
Ability to lead and persuade others within a matrix environment
Communication- ability to effectively communicate (verbal and written) ideas and data to engage and influence others
Leadership- ability to confidently and decisively coach and influence employees to accomplish program goals
Ability to demonstrate a high-level of business acumen
Problem solving - ability to recognize problems before they occur, to appropriately raise issues to management, to bring an insightful approach to problem solving, and to communicate issues to stakeholders in a mature, professional manner
Project Management – ability to manage multiple projects across different functions within medical affairs and create processes/systems to efficiently execute medical affairs program activities
Strong organizational skills – ability to organize information and data from various sources in an understandable and useful manner that is consistent with department standards
Strategic thinking - ability to approach specific issues/problems with understanding of the larger context
Analytical thinking- ability to gather information from multiple sources, identify issues and problems based on trends, organize and integrate information to provide insight for long-term planning
Systematic thinking- ability to understand a system or program by examining the linkages and interactions between the components that comprise the entirety of that defined system
Strategic thinking- ability to come up with effective plans in line with an organization's objectives within a particular economic situation to help business managers review policy issues, perform long term planning, set goals and determine priorities, and identify potential risks and opportunities
Presentation – ability to present information in a clear and concise manner
Ability to embrace diversity in thought and perspectives to support continual self and organizational improvement
Flexibility and responsiveness-ability to anticipate change and adapt strategies to maintain program integrity and accomplish Takeda’s business objectives
Relationship building-ability to cultivate a wide network of relationships both internally and externally and promote a team environment
Foster and manage change
Team building/management within program scope and across the department
Program and department focus
Resource management-ability to forecast and allocate resources appropriately
Risk management skills- ability to identify and measure risks that affect projects including accountability for project compliance
Product knowledge-understand the medical and therapeutic usage of Takeda’s products
Budget Management-develops an operating budget to monitor and control expenditures and manage budget variances
Innovation- identifies and pursues alternative cutting edge processes and opportunities in order to standardize processes implement efficiencies

Director, Global Medical Affairs, Lymphoma Resume Examples & Samples

Medical Lead for Franchise specific priorities within G3M teams
Support the VP GMADL in early pipeline disease strategy and compound development aspects
Lead Medical Affairs sponsored studies as applicable, ie planning & execution within appropriate standards for compliance, quality, timeliness, and budget
Oversee Medical activities (tactical) implementation of global Medical compounds of the brand/disease plans
Partner closely with regions on key Medical Education opportunities, track performance to goals/budget and Key Data Generation opportunities
Identify and oversee projects of real-world-data collection and registries
Collaborate with Medical Affairs colleagues to guide and execute therapeutic area strategy and tactics with appropriate use of resources and performance to goals
Assist Global Disease Lead as necessary for various activities of Global Disease Strategy Team
High quality scientific/clinical input and review of: Disease strategy/plans, abstracts, posters, slides, manuscripts in disease area, educational materials in disease area including slides, webcasts, etc., LOIs/ IIT protocols in disease area, steering committee and advisory board meeting objectives, materials, CTB, booth panels, Med info letters, CDPs, Commercial Brand plans, Integrated Disease Plans, ORQs in disease area, Scientific educational grant requests and patient advocacy grant requests
Represent Celgene at professional meetings, congresses, and local symposia
Assist with scientific searches, data summaries, preparation for site visits/corporate visits/payor presentations
Be a key partner to external stakeholders, as a scientific & strategic expert: key opinion leaders, cooperative study groups, Investigators, contribute and conduct global steering committees, scientific & strategic global advisory Boards, partner with advocacy groups
Advanced degree (Doctorate or Master’s) in health related field
Expertise in hematology/oncology including relevant content area, with 5-7 years industry experience
Expertise in the conduct of clinical trials in hematology/oncology
Excellent analytical skills and solid experience in translating medical/clinical information into medical affairs strategies
Proficiency in critical data review and interpretation
Product lifecycle management experience preferred
Good understanding of Medical Affairs and the compliance issues concerning MA function
Influence management of successful cross-functional and multi-disciplinary teams
Excellent communication and organization skills. Excellent presentation skills, including presenting to large groups, facilitation of interactive discussions, and 1:1 discussion with experts in the therapeutic area
Demonstrated customer focus orientation & credibility with customers
Knowledge/application of data sources, reports and tools for the creation of solid plans
Possess strong business acumen and financial skills. Budget experience
Regular travel will be required (20%)

Senior Manager Global Medical Affairs Resume Examples & Samples

Drive the medical publication strategy for assigned therapeutic area and or products. Is accountable for the delivery of the publication items and leads vendors in operationalizing the strategic publication plan, through building and leading a high-performing team. Ensures medical publications are delivered according to publication plan and predefined quality criteria. Plan and coordinate abstract submissions for major congresses. Identify new publication opportunities and collaborate with R&D functions to explore new content for publications
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.)
Monitor scientific progress and competitive activity in the assigned product area
Identify, develop and implement medical marketing initiatives (i.e. congress symposia, advisory boards, medical education/grant program). Contribute to development of medical and educational core promotional material and publications. Review medical content of promotional materials
Support training of staff of key countries as appropriate

Medical Director, Global Medical Affairs Resume Examples & Samples

Cardiovascular therapeutic area (esp. lipids)
Experience with stakeholder engagement and interactions (eg. opinion leaders, advocacy groups, payers)
In-depth understanding of scientific method and clinical applications based on medical, scientific and practical rationale
Knowledge of pharmaceutical product development, product lifecycle and commercialization process with advanced understanding of other functions; including, but not limited to, Clinical research, Commercial, Regulatory, Real World Evidence and biostatistics
Familiarity with concepts of Clinical trial design and Clinical Operations
Sound scientific/medical judgment
Familiarity with regulations and guidelines that govern pharma industry practices

Product Medical Lead IG Global Medical Affairs Resume Examples & Samples

A medical degree or scientific degree (PhD or Pharm D) is required
10 years of experience in biopharmaceutical medicine, preferably within a matrix or franchise structure
Experience in Medical Affairs is required

Director, Global Medical Affairs Lead Alpha Resume Examples & Samples

PharmD, MD or PhD
Minimum of 10 years previous work experience in Medical Affairs or pharmaceutical R&D
Previous experience and clinical expertise in pulmonology, immunology and/or rare diseases
Cross functional experience within MA or the pharmaceutical industry is desired
In-depth and up-to-date knowledge of alpha-1 antitrypsin deficiency/pulmonology preferred
Strong strategic skills related to product life-cycle management and evidence generation
Strong executional skills related to medical education, training, and advisory boards
Strong relational skills and history of previous significant relationships with KOLs, researchers, medical societies and/or advocacy groups
Strong medical analytics, writing and scientific presentation skills
Excellent verbal/written communication skills

Executive Director, Global Medical Affairs Resume Examples & Samples

Develop and execute on a comprehensive Medical Affairs strategic plan for all Ignyta development products
Recruit, train, and supervise Medical Affairs staff
Provide strategic Medical Affairs leadership and direction for development stage products
Provide medical/clinical/scientific information and expertise to all internal departments, including Commercial, Regulatory and Manufacturing
Provide clinical/scientific information to health care professionals and other customers consistent with FDA regulations
Oversee all publication team activities
Serve as a liaison with Commercial to ensure a smooth transition from development to commercialization of products
Identify, assess, and recommend potential new research areas for marketed products and products in development
Lead and develop Key Opinion Leaders (KOLs)
Actively develop, participate and support Ignyta clinical and marketing advisory boards and participate in local/regional/national research symposia upon request
Provide support in conducting safety reporting and surveillance of medical literature for new safety information
Lead all Continuing Medical Education (CME) activities
Lead dossier development for marketed products as needed
Lead Health Economics and Outcomes Research (HEOR) strategic planning and execution
Successful track record of leading a medical affairs department
Knowledge and expertise of adverse event reporting and drug-safety surveillance
Knowledge of the regulatory framework (FDA, DDMAC)
Experience with literature information databases
Management and supervisory experience (minumum 5 years) including experience with contractors and medical information service providers
Leadership, coaching and mentoring skills
Ability to manage large budgets, multiple projects, and timelines
Ability to collaborate cross-functionally across teams across the organization (clinical, legal, commercial)
Full understanding of all stages of pharmaceutical drug development process
Oncology therapeutic experience
Publication and manuscript preparation experience

Medical Director, Global Medical Affairs Resume Examples & Samples

Assists senior leadership with assessments, and intelligence on potential new products, joint ventures, corporate partnership and due diligence activities
Provides clinical support for field sales efforts and medical science liaisons to help them provide the scientific and clinical information necessary to improve patient care
Identifies, develops and maintains close professional relationships with influential members/opinion leaders (physicians and researchers) within pertinent medical community. Fosters the establishment and maintenance of external scientific advisors and assists in advocacy development
Remains informed of current developments within pertinent medical and scientific communities through familiarity with current literature, attendance at meetings, conventions, professional associations, etc
Medical Degree (MD) or another advanced degree, e.g., PhD or Pharm D and 4+ years pharmaceutical or related industry experience (in country) with 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
Respiratory, internal medicine, and MA experience preferred
Customer expertise especially scientific leadership and other key stakeholders (public groups, government officials, medical professional organizations)
Proven ability to effectively communicate information at management level
Excellent interpersonal, analytical, communication (written as well as oral), results oriented project management, facilitation and consultative skills to influence decision making
Requires working knowledge of Good Clinical Practices, Food and Drug Administration regulatory reporting requirements
Clinical research experience. 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
Proficiency in speaking, comprehending, reading and writing English is required

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