Global Labeling Strategy Sr. Manager - TA Head

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Global Labeling Strategy Sr. Manager - TA Head

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What you will do

Let’s do this. Let’s change the world. The purpose of the Global Labeling (GL) group is to develop and maintain core labeling documents to provide quality product labels and drive global labeling strategy to ensure safe and effective use of Amgen products for patients and healthcare providers around the world.

The Therapeutic Area Lead, reporting to the Head of Global Labeling, directs and leads the Labeling Strategists within a Therapeutic Area (TA). In this vital role, you will be a member of the Global Labeling Leadership Team, with accountability for the strategic labeling content within a Therapeutic Area, over the product(s) life cycle.

Responsibilities will include:

• Global labeling strategy development and implementation
• Ensuring accuracy and consistency in the development review, approval and maintenance of core product labeling documents
• Global review and approval of regional deviations from core content
• Organization of all global and cross-functional activities related to the labeling content processes
• Provide expert interpretation of international regulations affecting global labeling
• Directs strategic content for Labeling within a TA (including dCDS/cCDS, dIFU/cIFU, cPIL, maintenance agreements, and other core components)
• Accountable for strategic and tactical guidance to product labeling review teams regarding labeling development and maintenance of corporate labeling documents
• Accountable to partner with Human Factors and Quality Engineers to ensure comprehensive and competitive IFUs within Design Control procedures
• Ensures labeling processes support the development of accurate, current consistent, comprehensive and competitive global labeling
• Reviews and comments on the internal and external guidelines and regulations related to regulatory, safety, and legal topics
• Accountable for ensuring compliance with global regulatory requirements and adherence to internal regulatory policies and processes
• Provides advice and support to the Labeling Strategist on key labeling decisions or on critical issues involving labeling review committees (e.g. Labeling Working group, Executive Labeling Board or Senior Management Team)
• Chairs the Executive Labeling Board
• Provides input and strategic guidance to the Target Product …