Labeling Strategist, Manager (open for remote)

Labeling Strategist, Manager

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 & post marketed products over the products 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).

Principal responsibilities include, but are not restricted to :

• 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%

Basic Experience : 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 10 years of related experience

OR High school diploma / GED and 12 years of related experience

Preferred Experience :

Thrive :

What you can expect of us :

As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors, including but not limited to, relevant skills, experience, and qualifications.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work / life balance, and career development opportunities including :