Global Medical Affairs Job Description
Global medical affairs
provides oversight and direction to study team members for study deliverables; may provide direction to Clinical Study Managers, Associate Clinical Study Managers and Clinical Trial Associates for assigned studies.
Global Medical Affairs Duties & Responsibilities
To write an effective global medical affairs job description, begin by listing detailed duties, responsibilities and expectations. We have included global medical affairs job description templates that you can modify and use.
Sample responsibilities for this position include:
Be responsible for leading the clinical-commercial optimization of product development and life cycle management strategies and plans for the assigned marketed compounds and compounds in clinical development within the Immunology TA
Be a member of the Compound Development Teams, the Safety Management Teams and Global Commercial Teams, Labelling working group, ad hoc member of the Clinical Team and Global Market Access Team and will be responsible for development of the global medical affairs plan that reflects prioritized regional needs and which are included in the overall Compound Development Plan
As delegated by the Global Medical Team leader, lead functional
As delegated by the Global Medical Team leader, participate in development of product strategy
Collaborate with Global Medical Affairs teams to identify medical training and professional development needs
Collaborate with GMA teams to create and implement strategic and in-year tactical Global Medical Training curricula
Create disease state and product trainings in conjunction with GMA teams
Assist in monitoring Global Medical Training performance and implement initiatives to drive organizational excellence
Assist in the management of Shire’s Global Independent Medical Education (IME) request management system
Review and processing of US Independent Medical Education (IME) requests
Global Medical Affairs Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Global Medical Affairs
List any licenses or certifications required by the position: PMP, ABPI, MD, CMPP, M.D, ITIL
Education for Global Medical Affairs
Typically a job would require a certain level of education.
Employers hiring for the global medical affairs job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Medical, Science, Business, Life Sciences, Project Management, Education, Communication, Medical School, English, Pharmacy
Skills for Global Medical Affairs
Desired skills for global medical affairs include:
Study methodology
Clinical trial methodology
Study execution
Study data reviews and analysis
Commercial
Pharmaceutical product development
Both J&J and competitors
Regulatory
Clinical operations
Commercialization processes
Desired experience for global medical affairs includes:
Support management of system vendor
Support global IME process for review, approval, management and tracking of grants
Support GMA project development/harmonization
Work with the GMA Head, Pipeline and Pipeline Medical Team (PMT) or Global Medical Team (GMT) to develop medical strategy, including R&D LCM strategy, publications strategy, congress strategy, customer interaction strategy, and the scientific communication platform for the disease area / brand(s), aligned with product strategy and in accordance with the POM/ GMT charter
As delegated by the GMA Head, Pipeline, lead functional
As delegated by the GMA Head Pipeline, participate in development of product strategy
Global Medical Affairs Examples
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Global Medical Affairs Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of global medical affairs. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for global medical affairs
- Be accountable for the global publications plans, global opinion leader relations, global medical education (including symposia, speaker training) and global advisory boards for products starting in early development (phase IIA) and through launch of major life cycle management initiatives (earlier or later as needed)
- Be responsible for facilitating and ensuring a consistent approach to Medical Affairs programs/activities globally
- Represent global medical affairs on the Rheumatology Disease Area Stronghold team
- Develop global medical affairs strategy and plan for the assigned compounds based on prioritized regional needs, Working with the CDT ensures integration with the overall global compound strategy, resulting in one global R&D and Medical Affairs compound development plan, inclusive of developing a Target Product Profile representing medical affairs global and regional value needs
- Provide single Medical Affairs voice into the creation of compound development and LCM strategies, plans and trial design from phase IIa through phase IV
- Be responsible for pre-launch medical activities including product/Therapeutic Area global advisory boards, medical symposia and congress activities, coordination of regional activity in these areas
- Be an active member of the CDT and will lead a global Medical Affairs TA Team consisting of regionally designated Therapeutic Area Medical Affairs Leaders to create one medical affairs perspective and one “unified” voice on the CDT
- Be responsible for the development and execution of the global publication plan review and approval of publications for marketed products and specified compounds in clinical development
- Manage the ReCAP process (review of all medical affairs sponsored clinical trials and Investigator Initiated Sponsored studies) for applicable products
- Support development of the Company risk management strategy and plan author and review specific sections of the Periodic benefit-risk assessment report for compounds
Qualifications for global medical affairs
- Be responsible to ensure all global activities follow J&J Compliance principles, eg
- Developing internal global communications and education for Novartis products
- Presentation to upper management, CPOs and Regions
- Including interpretation in collaboration with GBMD & brand team of key competitor data
- Conducts ongoing analysis of clinical market, health care reform and industry trends to develop key supporting strategies to meet business objectives
- Collaborate with Managed Care, Global and Regional Brand Teams and HEOR in the conduct of payer advisory boards including but not limited to Managed Care Organizations, Medicare and Medicaid professionals and Pharmacy Benefit Managers, HTAs
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Global Medical Affairs Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of global medical affairs. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for global medical affairs
- Provide day-to-day operational support of Global strategic and tactical medical functional planning activities across Global TAs working closely with Global Commercial Operations on overall Brand Plan framework and guidance
- Lead day-to-day planning support for GMA annual Financial Plan and LRP working closely with GMA Project Management organization, Finance team and Global Commercial organization
- Leverages TA resources and attends appropriate medical congresses and scientific forums of interest and payer meetings to maintain business and clinical knowledge of assigned therapeutic areas, including current treatment strategies, current and pending competitors, and new therapeutic developments
- Oversees scientific/medical education of investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information
- Provides expert opinion on the current trends in the pathophysiology, diagnosis, existing and emerging treatment options unmet medical needs in the therapeutic area to inform key medical and business
- Work closely with VP and Senior Medical Director of Global Medical Affairs Oncology to work with R&D team to set direction, implement strategy and ensure delivery of outcomes for Global Medical Affairs function
- Work closely with R&D oncology team to integrate medical strategies into early pipeline plans, projects and processes
- Provide guidance to Medical Team to assure delivery of key Medical Affairs Oncology objectives as related to Medical Affairs medical plan and corporate objectives, and in a highly dynamic environment
- Integrate strategies, tactics and programs to accomplish Medical Affairs Oncology objectives
- Set, track and provide status updates about Medical Affairs Oncology programs and related processes within the department
Qualifications for global medical affairs
- Work in and enable a positive team environment and interact with global clinical, scientific and marketing team
- Leverage relationships with external customers to ensure robust and compliant physician and patient insights to drive successful product launches and medical communications
- Interface internally and externally with key stakeholders, managed care leaders, and the broader scientific community to lead and execute medical strategy of innovative and differentiated medicine, ensuring the medical community is appropriately engaged with the information they need to support patient care needs scientific advisory boards, webinars and presentations
- MD, PhD, or PharmD required
- Specialty training in Dermatology or significant medical affairs dermatology experience within the pharmaceutical industry
- At least five years clinical experience preferred
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Global Medical Affairs Job Description
Job Description Example
Our company is growing rapidly and is hiring for a global medical affairs. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for global medical affairs
- Provide program management support in the development, communication, and implementation of Medical Affairs programs, policies and procedures
- Represent Oncology Medical Affairs on the Medical Academy Council and supervise development of all Oncology Medical Affairs training materials
- Collaborate with other therapeutic areas to leverage Medical Affairs Oncology expertise and programs as appropriate
- Work closely with and ensure collaboration between Medical Affairs Oncology and all other functions within the CMO organization
- Provide close collaboration and alignment of goals and objectives with strategic partners
- Work with MSL team to support R&D initiatives including clinical trial investigator site selection, and training of trial investigators
- Serves as the primary liason with internal auditing/compliance functions and reviews all medical affairs-related audit reports to track findings and remediation activities across the GMA department
- Leads the development and/or revision of Global policies, standard operating procedures (SOPS), and work instructions(WI) for Global Medical Affairs, including collaborating with the GMA Leadership Team to identify needs, faciitlating a cross-functional/regional working group to develop draft procedures, and obtaining leadership review and approval
- Consults with and supports the GMA Regions in the development and/or revision of regional or country level SOPs and WIs, including reviewing to ensure alignment to global policies and procedures, consulting/providing feedback on regional/country level processes, and where needed, supporting the leadership review and approval process
- Serves as main GMA point of contact for the review and approval of policies/procedures owned by other departments where Medical Affairs has a role/responsibiilty, including coordinating the review across relevant GMA regions/functions and resolving comments to ensure medical affairs’ roles/resopnsibilities are accurately reflected
Qualifications for global medical affairs
- Demonstrated experience with developing medical strategies, plans and execution in pharmaceutical environment at the leadership level
- Pharmaceutical experience in rare diseases and dermatology
- A minimum of 30% domestic and international travel
- M.D., D.O., or equivalent degree with work experience in the area of neurology
- Minimum 8 years of progressive experience in the therapeutic area, preferably in the biotech or pharmaceutical industry or similar academic institution, is required
- Strong interpersonal skills commensurate with the need to effectively manage teams of peers and to work closely with both external physicians/scientists and numerous in-house support groups
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Global Medical Affairs Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of global medical affairs. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for global medical affairs
- Manages the GMA procedural document deviation process, including consultation and review of any prospecitive or retrospective deviation, tracking all deviations, and performing periodic review to determine necessary process changes and/or training or reinforcement
- Leads a cross-functional procedural document network, enabling functions such as Clinical, Medical Affairs, Regualtory, and Pharmacovigilance to share procedures best practices and be kept aware of and invovled in current and upcoming procedures development activities across all functions
- Owns the GMA procedural document development process and defines and implements process improvement and efficency changes, moving to electronic review and approval of documents
- Tracks and maintains procedural document metrics
- In collaboration with GMA T&P team members, ensures the GMA organization is appropraitely trained on GMA procedures
- Global Medical ‘point of contact’ for the designated medicine(s) within the migraine & headache franchise
- Provide day-to-day operational support for Global Medical Affairs and play a critical role in supporting governance to enhance decision-making
- Lead execution of standard planning & operational processes and tools including timelines, budgets, risk management plans, and communication plans for operational initiatives
- Provide day-to-day operations and execution support of the Medical Affairs Team (MAT) Enabling Team (ET) including managing and leading work streams and developing and coordinating MAT Leaders Forums
- Lead day-to-day execution and support of Launch Readiness guidance and training utilizing the MA Launch Readiness framework working with Global PMs and TAs
Qualifications for global medical affairs
- Provide strategic Global Medical input to clinical development, pre-registration, pre- and post-market launch strategies, and life cycle management
- Develop and implement reliable and high-value communication strategy for a new product
- Global medical affairs support for in-line and pre-launch products, including strategic and tactical planning and design, implementation and timely completion of Phase 4 studies and addressing post-marketing concerns
- Knowledge of scientific methods, research design and medical practices and procedures that would be acquired
- Advanced degree (Doctorate) in molecular biology, genomics, cancer biology or other relevant life sciences area required
- Solid experience in clinical /translational research and/or medical affairs in hematology or oncology with 7 -10 years industry experience required
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Global Medical Affairs Job Description
Job Description Example
Our growing company is looking for a global medical affairs. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for global medical affairs
- Actively participates in advancing and communicating corporate and GMA philosophy and agenda
- Direct and continue to develop the global operations functions, with forward-looking strategic emphasis on financial systems, legal, compliance, technology, strategy, and research
- Oversee creation and implementation of global standards and procedures
- Develop strategies for the integration of new programs including in-licensed products as it relates to GMAF
- Participate in the leadership of the MAF global programs team
- Oversee the integration of new corporate mandates and changes in technology impacting GMAF teams
- Oversee operational aspect of Global Independent Research Program
- Participate in leadership team of MAF global programs
- Work with teams to develop new and consistent policies, SOPs and work instructions
- Liaise with key internal stakeholders to assure communication is consistent amongst GMAF and support functions
Qualifications for global medical affairs
- Regular travel will be required (approx 20%)
- English (German a plus)
- Minimum of 5 years of managerial responsibilities in the pharmaceutical/healthcare industry with demonstration of successful results
- Prior experience of at least 3 years in Oncology Medical Affairs required
- Demonstrated understanding of the clinical development and post-marketing environment for pharmaceuticals including post-marketing clinical studies and medical affairs strategic initiatives
- Demonstrated ability to work with teams, manage a diverse work group, motivate them, and maximize productivity