This job is closed
We regret to inform you that the job you were interested in has been closed. Although this specific position is no longer available, we encourage you to continue exploring other opportunities on our job board.
Senior Manager, Global Labeling Lead
Pfizer - Bothell, WA
posted 2 months ago
About the position
The Senior Manager, Global Labeling Lead (GLL) is responsible for the development and execution of global labeling strategies for assigned products at Pfizer. This role involves managing the entire labeling process, including Target Labeling in early development, Core Data Sheets (CDS), and submissions for US Prescribing Information (USPI) and EU Summary of Product Characteristics (EU SmPC). The position offers high visibility and the opportunity to collaborate cross-functionally, contributing to strategic initiatives and supporting Pfizer's Oncology pipeline.
Responsibilities
- Lead the development, maintenance, and implementation of high quality labeling including CDS, USPIs, EU SmPCs, and patient labeling
- Author labeling content de novo based on scientific source data, understanding of regulations and guidance, and label precedent
- Manage cross-functional Labeling Team and collaborate with stakeholders including Clinical, Medical, Safety, Regulatory, and Commercial
- Drive global labeling strategy through development of target labeling, scenario planning, and risk mitigation
- Manage label negotiations with US FDA and EMA
- Provide guidance on labeling regulations, industry best practices, and competitor label assessments
- Act as the primary labeling representative on Global Regulatory Strategy Teams, Submission Working Groups, and other relevant product teams
- Contribute to strategic initiatives and process improvements across the organization
Requirements
- Bachelor's degree in a scientific or technical discipline
- Minimum of 8 years of relevant labeling experience in the pharmaceutical or biotech industry
- Advanced knowledge of external labeling guidelines and regulations
- Ability to successfully understand regulatory implications of product strategy with regards to the product label, assessment and practical management of associated impacts
- Ability to develop strong and positive working relationships with cross-functional stakeholders and SMEs
- Excellent written and verbal communication skills; complete fluency in English language
- Proven strength in logical, analytical and writing ability
- Strong project management skills and attention to detail
- Proven ability to negotiate, influence and problem solve
- Oncology experience strongly preferred
Benefits
- 401(k) plan with Pfizer Matching Contributions
- Paid vacation, holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits including medical, prescription drug, dental and vision coverage
- Relocation assistance may be available based on business needs and/or eligibility
