Labeling Strategist

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

What you will do

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 to ensure safe and effective use of Amgen products for patients and healthcare providers around the world.

As part of Global Labeling Strategy and Compliance (LSC), and under the supervision of the Therapeutic Area Obesity and Related Conditions Assistant Vice President, the Labeling Strategist, Sr. Manager is responsible for the facilitation and management of the end-to-end labeling processes for pre & post marketed products over the product’s life cycle. The Labeling Strategist, Sr. Manager will lead the development of the Core Labeling documents and US Labeling deliverables in accordance with Amgen Labeling Processes for assigned therapeutic area(s).

Responsibilities

• Chairs/leads Labeling Working Group and presentations to Cross-Functional Executive Labeling Board meetings.  
• Leads the development and maintenance of core labeling documents including Core Data Sheet (CDS), core patient information leaflet (cPIL), and core instructions for use (cIFU)and regional labeling such as the US Prescribing Information (USPI), US patient labeling such as the patient prescribing information (PPI) and medication guide.
• Represents labeling on product-specific global regulatory teams and informs on GRT decision which impact any relevant portfolio assets, 
• Provides input and leads the strategic guidance to Target Product Labeling,
• Manages compounds with a medium to high degree of complexity from a labeling perspective.
• Provides strategic guidance on labeling regulations, requirements, competitor labeling, and labeling trends to other Labeling Strategist …