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Gmpe Manager

6+ years
Not Disclosed
10 Dec. 26, 2024
Job Description
Job Type: Full Time Education: PhD/M. Pharm/PharmD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Global Medical Product Evaluation (GMPE) Manager


Role Summary

The GMPE Manager is a vital member of the Medical Affairs team, responsible for medical leadership, global product strategy, and comprehensive product maintenance and defense activities for an assigned portfolio. Reporting to the GMPE Team Lead, the role ensures robust medical oversight and strategic support for the portfolio's lifecycle.


Key Responsibilities

Strategic Oversight

  • Provide strategic medical leadership for planned and ad-hoc product maintenance and defense activities.
  • Offer medical input on amendments to product labeling, benefit-risk assessments, Periodic Benefit-Risk Evaluation Reports (PBRERs), and regulatory submissions, including PSURs, ACOs, and product renewals.

Collaboration and Stakeholder Management

  • Partner with Pfizer Global Supply (PGS), Communications, and Medical Information teams on product queries, supply interruptions, and out-of-stock situations.
  • Work collaboratively with regional country medical teams, Chief Medical Affairs Office (CMAO), and Chief Medical Office (CMO) for product withdrawals or discontinuations.

Medical Leadership in Quality and Safety

  • Serve as a key member of Area Quality Review Teams (AQRTs) and author Health Hazard Assessment (HHA) reports.
  • Lead Product Benefit-Risk Committees (PBRCs) and present clinical efficacy assessments to relevant committees, including BU-BRCs and E-BRCs.

Regulatory and Compliance Expertise

  • Provide expertise on reformulation efforts, regulatory submissions (e.g., aNDAs, sNDAs), and Risk Management Plans (RMPs).
  • Support global compliance initiatives such as PLR conversions, REMS, label harmonization, and internal/external audits.

Product Inquiries and Strategic Inputs

  • Address regulatory, safety, legal, and internal product inquiries.
  • Participate in Rapid Response Teams (RRTs) to deliver on product-related objectives globally.

Required Skills and Experience

Technical Expertise

  • Proficiency in Microsoft Word, PowerPoint, Excel, and corporate systems like Pfizerclinicaltrials.com, GDMS, and PEARL.
  • Experience in product maintenance, regulatory affairs, and defense-related activities.
  • Demonstrated ability to manage a large product portfolio efficiently.

Educational Background

  • PhD, PharmD, or MPharm with a minimum of 6 years’ experience in a global pharmaceutical environment.

Key Competencies

  • Strategic Thinking: Pragmatic, proactive, and adaptable approach to problem-solving.
  • Communication: Strong presentation and interpersonal skills with a focus on clarity and influence.
  • Organizational Agility: Understanding of organizational cultures, policies, and procedures.
  • Time Management: Effectively prioritizes tasks to meet team and personal goals.
  • Process Optimization: Skilled at creating efficient workflows and building new processes.

Experience

  • Preferred experience in Global Medical Product Evaluation or related functional areas.
  • Proven ability to collaborate effectively in matrixed environments with internal and external stakeholders.

Work Environment

  • Location: Remote
  • Pfizer is an equal opportunity employer committed to inclusivity and compliance with equal employment opportunity legislation worldwide.

Medical
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