The purpose of the Labeling Strategy and Compliance (LSC) group is to develop and maintain quality core and regional labeling documents and drive global labeling strategy.
Leads the development of the Core Labeling documents and US Labeling deliverables in accordance with Amgen Labeling Processes.
Chairs/leads Labeling Working Group and presentations to Cross-Functional Executive Labeling Board meetings.
Ensures deviations from labeling procedures and policies are escalated appropriately.
Manages the review and approval of core DHCP letters.
Provides strategic labeling advice for major regions and works with cross-functional teams to ensure that the execution of global regulatory labeling plans are aligned with global regulatory strategies.

Doctorate degree OR Master’s degree and 2 years of related experience OR Bachelor’s degree and 4 years of related experience OR Associate’s degree and 8 years of related experience OR High school diploma / GED and 10 years of related experience
Degree in life science or medicine
Experience in Pharmaceutical Industry Regulatory Affairs and /or product labeling
Expertise in product labeling within a Therapeutic Area
Knowledge of FDA, EMA, and other international regulations for labeling
Project Management Skills
Understands the impact of emerging trends and their implications for Amgen
Experience in managing individual and group projects of high to moderate complexity
Experience working in a Veeva/Documentum-based document management system.

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
group medical, dental and vision coverage
life and disability insurance
flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible.

Labeling Strategist – Manager

Key skills