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Gmpe Manager

6+ years
Not Disclosed
10 Dec. 27, 2024
Job Description
Job Type: Full Time Education: PhD/PharmD/MPharm 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 Description

Job Title: Global Medical Product Evaluation (GMPE) Manager


Role Summary

The GMPE Manager is a key member of the Medical Affairs team, responsible for providing strategic medical oversight and leadership for the assigned product portfolio. Reporting to the GMPE Team Lead, the GMPE Manager leads product maintenance and defense activities, ensuring compliance and supporting benefit-risk assessments, regulatory submissions, and cross-functional collaborations.


Key Responsibilities

Strategic Oversight

  • Provide strategic medical leadership for product maintenance and defense activities.
  • Assess the benefit-risk profile of products in response to labeling amendments, clinical overviews, and safety reports (e.g., PBRERs, PSURs).
  • Lead cross-functional committees such as Product Benefit Risk Committees (PBRCs) and BU-Benefit-Risk Committees (BU-BRCs).

Medical Expertise

  • Offer subject matter expertise for regulatory submissions, including reformulations, abbreviated and supplemental applications (aNDAs, sNDAs, MMAs).
  • Author Health Hazard Assessment (HHA) reports in collaboration with Pfizer Global Supply (PGS) and Area Quality Review Teams (AQRTs).
  • Provide input for PLR conversions, Risk Management Plans (RMP), REMS, and labeling harmonization efforts.

Collaboration and Communication

  • Partner with PGS, Communications, and Medical Information teams to address supply interruptions or out-of-stock scenarios.
  • Collaborate with regional country medical teams, CMAO, and CMO on product withdrawals and discontinuations.
  • Manage internal and external audits, ensuring alignment with governance and compliance standards.

Operational Excellence

  • Manage a large portfolio of products, balancing competing priorities to deliver timely and accurate outcomes.
  • Contribute to Rapid Response Teams (RRTs) and other cross-functional groups to address urgent product issues.
  • Lead or participate in continuous improvement initiatives to enhance team and process efficiency.

Required Skill Set

Technical Skills

  • Strong proficiency in Microsoft Word, PowerPoint, and Excel.
  • Working knowledge of Pfizer systems (e.g., GDMS, PEARL, Pfizerclinicaltrials.com).
  • Ability to work independently and effectively manage multiple tasks.
  • Demonstrated capability to manage complex product portfolios.

Education and Experience

  • PhD, PharmD, or MPharm with 6+ years of global pharmaceutical experience.
  • Experience in Global Medical Product Evaluation is preferred.
  • Proven track record of high performance in matrixed team environments.

Competencies

  • Change Management: Adaptable and comfortable with ambiguity; able to make decisions with incomplete information.
  • Time Management: Efficiently prioritizes tasks to focus on key deliverables.
  • Process Management: Designs and implements effective workflows and processes.
  • Organizational Agility: Understands organizational culture and aligns actions with key policies and practices.

Behavioral Traits

  • Strong interpersonal, communication, and presentation skills.
  • Solution-oriented, collaborative, and team-driven.
  • Commitment to compliance and governance.

Work Location Assignment: Remote

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Medical
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