Global IVD Regulatory Center of Excellence Portfolio Manager
Pfizer
Full-time
Remote friendly (Bothell, WA)
United States
$120,800 - $201,400 USD yearly
Operations
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Role Summary
Global IVD Regulatory Center of Excellence Portfolio Manager. Oversees oncology regulatory strategy programs within the IVD COE, supporting development and delivery of medicines and diagnostics.
Responsibilities
- Oversee a global portfolio of IVD regulatory projects, ensuring timely initiation and execution of cross-functional study start-up activities.
- Plan and schedule project timelines and milestones using appropriate tools prior to study start-up.
- Forecast and plan resource requirements (people, financial, technology) for projects across the IVD Regulatory COE/Portfolio.
- Lead and support cross-functional issue resolution and mitigation activities, both internally and externally.
- Coordinate and lead discussions between Oncology Regulatory Strategy and CTRSE Regulatory PM (GSPM) to ensure alignment of decisions.
- Manage and participate in pre-studies, projects, and other activities to increase operational efficiencies and support business imperatives.
- Facilitate dissemination of educational and training materials to advance new concepts and methodologies.
Qualifications
- Must-Have: Bachelor’s degree required; Master’s degree preferred.
- Direct experience leading projects in a highly regulated environment.
- Proven ability to manage multiple projects with competing deadlines.
- Knowledge of IVD manufacturing and associated processes.
- Excellent oral and written communication skills.
- Proficiency with Microsoft applications.
Nice-to-Have
- Experience managing pharmaceutical, technical, IVD, or medical device projects and/or clinical programs.
- Experience leading regulatory submissions for IVD and/or drug applications.
- Experience with Microsoft Project or equivalent systems.
- Certification in operational excellence methodologies (e.g., Six Sigma, Lean).
Skills
- Project leadership in regulated environments
- Cross-functional collaboration
- Regulatory strategy and coordination
- Resource forecasting and portfolio management
- Educational material development and dissemination
Education
- Bachelor’s degree required; Master’s degree preferred.
Additional Requirements
- Hybrid work location.