Labeling Strategist
Core
Develop and maintain global core and regional labeling documents to ensure safe and effective use of Amgen products for patients and healthcare providers.
Role type
Senior Manager, Labeling Strategist
Builds
Core Data Sheets, patient information leaflets, instructions for use, and regional prescribing information for obesity and related conditions.
Domain
Biotechnology / Regulatory Affairs / Pharmaceutical Labeling
Required skills
Strategic labeling guidance, regulatory compliance management, cross-functional team leadership, complex project management, technical writing, regulatory document review, stakeholder negotiation, regulatory trend analysis, document management system proficiency.
Preferred skills
Life science or medicine degree, pharmaceutical regulatory affairs experience, FDA/EMA regulation expertise, Veeva/Documentum system experience, managing high-complexity labeling projects.
Responsibilities
Lead Labeling Working Group and present to Cross-Functional Executive Labeling Board; develop and maintain core labeling documents (CDS, cPIL, cIFU) and US labeling (USPI, PPI); provide strategic guidance on Target Product Labeling; advise on labeling regulations and competitor analysis; manage review and approval of core DHCP letters; assist in preparing responses to Health Authority queries; supervise direct reports.
Seniority
Senior Manager, hands-on leadership
