Job Title: Global Medical Product Evaluation (GMPE) Manager
Location: Remote
Job Level: Manager
Department: Medical Affairs
Role Summary:
The Global Medical Product Evaluation (GMPE) Manager is a key member of the multifunctional Medical Affairs team and reports directly to the GMPE Team Lead. This role provides global product strategy and medical leadership for assigned products, supporting product maintenance, defense activities, and ensuring compliance with medical, regulatory, and safety standards. The GMPE Manager will play a significant role in driving product benefit-risk evaluations, handling global supply issues, and managing the overall lifecycle of products.
Key Responsibilities:
Strategic Leadership & Oversight:
Product Maintenance & Defense: Lead strategic medical oversight for product maintenance, including addressing the impact of amendments in product labeling on benefit/risk, supporting clinical overviews, and contributing to Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum Reports, and product renewals.
Collaborate Across Teams: Partner with PGS, Communications, and Medical Information teams to address product queries, press releases, and issues like supply interruptions or stockouts.
Support Product Withdrawals/Discontinuations: Provide medical leadership and strategic input during product withdrawals or discontinuations in collaboration with regional medical teams and senior leaders in Medical Affairs.
Global Supply Issues: Work closely with the Area Quality Review Teams (AQRTs) to provide medical oversight on global supply issues and contribute to Health Hazard Assessment (HHA) reports.
Benefit-Risk & Clinical Oversight:
Lead Benefit-Risk Committees: Lead Product Benefit-Risk Committees (PBRCs) and present assessments of clinical efficacy at various product committees to ensure appropriate risk management and product defense strategies.
Medical Leadership in Submissions: Provide input for reformulation efforts, abbreviated and supplemental submissions (aNDAs, sNDAs, MMAs, aMMAs), and other regulatory submission processes.
Product Strategy and Compliance: Offer subject matter expertise on regulatory matters, including Product Labeling and Risk Management Plans (RMP), and ensure compliance with applicable medical standards and regulations.
Product Evaluation & Compliance:
Manage Medical Inputs: Provide medical input for various internal and external product queries, including regulatory, safety, legal, and quality-related matters.
Support Audits and Conversions: Contribute to product PLR conversions, REMS, label harmonization efforts, and support audits across global teams.
Continuous Improvement: Contribute to process improvements to enhance team effectiveness and streamline product evaluation activities.
Required Skills:
Technical & Functional Expertise:
Product Maintenance & Defense Knowledge: Deep understanding of product lifecycle management, including benefit-risk analysis, product evaluation, and clinical strategy.
Proficiency in Tools & Systems: Expertise in Microsoft Word, PowerPoint, Excel, and corporate document management systems such as Pfizerclinicaltrials.com, GDMS, and PEARL.
Proactive & Strategic: Ability to think strategically, lead product evaluation activities, and address complex challenges proactively.
Leadership & Collaboration:
Interpersonal & Communication Skills: Strong communication and presentation abilities to engage with internal and external stakeholders, ensuring alignment and buy-in on product strategies.
Teamwork & Problem-Solving: Collaborative approach to working across matrix teams and driving solutions to complex product issues.
Compliance & Governance Focus: Demonstrated commitment to compliance and governance in all medical evaluation processes.
Organizational & Time Management Skills:
Time & Process Management: Effective in managing multiple tasks, prioritizing high-impact activities, and optimizing workflows for product evaluation.
Organizational Agility: Ability to navigate complex organizational structures and align with key policies and practices.
Education & Experience:
Required Education: PhD, PharmD, MPharm, or related degree.
Experience: Minimum of 6 years in a global pharmaceutical environment with experience in Global Medical Product Evaluation or similar functions. Ability to manage a large product portfolio is essential.
Independent Worker: Must be able to work independently without direct supervision, demonstrating initiative and leadership across product teams.
Work Location:
Remote
Pfizer's Commitment:
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction where it operates. We are committed to fostering an inclusive workplace where all employees feel valued and empowered.
#LI-Remote #LI-PFE
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