Labeling Strategist, Manager

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity‑related conditions.

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.

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.

As part of Global Labeling (GL), and under the supervision of the Therapeutic Area Lead, the Labeling Strategist, Manager is responsible for supporting the facilitation and management of the end‑to‑end labeling processes for the pre‑and‑post‑marketed products over the product life cycle. The Labeling Strategist, Manager will support the development of the Core Labeling documents and USPI in accordance with Amgen Labeling Processes for assigned therapeutic area(s).

Lets do this. Lets change the world. In this vital role you will [top‑line statement connecting primary position responsibility to employer brand].

• Authors (user friendly, international language, consistent across products) and maintains core labeling documents including cCDS, cPIL, and cIFU in addition to dCDS, dIFU, USPI, and medguide
• Chairs/leads the Labeling Working Group, and presents to Executive Labeling Board
• Provides strategic guidance on labeling regulations, requirements, competitor labeling, and labeling trends
• Advises internal and/or external specialists on the creation of high quality documents supporting changes to the core labeling documents and runs the annotations within those documents
• 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.
• Works with customer experience, packaging engineering, branding, HF, and artwork center to create layout templates for use in HF studies
• Represents labeling on product‑specific global regulatory teams
• Amount of travel required 10%

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a go‑getter with these qualifications.

• Doctorate degree
• Masters degree and 2 years of related experience
• Bachelors degree and 4 years of related experience
• Associate degree and 10 years of related experience
• High school diploma / GED and 12 years of related experience

• Degree in pharmaceuticals, natural science or medicine
• Experience in Pharmaceutical, Biotechnology and/or Medical Device industry and product labeling
• Knowledge of labeling within a Therapeutic Area
• Knowledge of FDA, or EMA, or other international regulations for labeling
• Collaboration, presentation, communication, interpersonal, and leadership skills
• Experience working in a Documentum-based document management system

As we work to develop treatments that take care of others, we also care for your professional and personal growth and well‑being. From our competitive benefits to our collaborative…