Regulatory Labeling Mgr

Amgen is seeking a Regulatory Labeling Manager to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more about this position:

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 Inflammation/Nephrology/Biosimilars Therapeutic Area Lead, the Labeling Strategist, Manager is responsible for the facilitation and management of the end-to-end labeling processes for pre and post marketed products over the product life cycle. The Regulatory Labeling Manager will manage the development of the Core and US labeling documents in accordance with Amgen labeling processes for assigned therapeutic area(s).

Responsibilities for the Regulatory Labeling Manager include:

• Authors and maintains core labeling documents including Core Data Sheet (CDS), core Patient Information Leaflet (cPIL), core Instructions for Use (cIFU), development Core Data Sheet (dCDS), development Core Instructions for Use (dIFU), and United States Prescribing Information (USPI).
• Chairs/leads Labeling Working Group and presentations to Executive Labeling Board meetings.
• Advises internal and/or external experts on the creation of high-quality documents supporting changes to the core labeling documents and manages 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.
• Provides input and strategic guidance to the Target Product Label.
• Reviews and approves deviations from core labeling.
• Ensures deviations from labeling procedures and policies are escalated appropriately.
• Assists in preparation of responses to labeling-related Health Authority queries.
• Incorporates feedback from Human Factors (HF) studies into the cIFU and associated labeling.
• Works with customer experience, packaging engineering, branding, HF, and artwork center to create layout templates for use in HF studies.
• Supports HF studies in evaluation of participants output during the studies.
• Manages the review and approval of core Dear Health Care Provider (DHCP) letters.
• Represents labeling on product-specific Global Regulatory Teams.
• Domestic and international travel 10%

Basic Qualifications

Doctorate degree

OR

Master's degree and 2 years of Pharmaceutical/Biotech or CRO industry experience

OR

Bachelor's degree and 4 years of Pharmaceutical/Biotech or CRO industry experience

OR

Associate's degree and 10 years of Pharmaceutical/Biotech or CRO industry experience

OR

High school diploma / GED and 12 years of Pharmaceutical/Biotech or CRO industry experience

Preferred Qualifications

BS Degree in natural science

Previous experience working in industry in support of Global Labeling or Regulatory Affairs

Accomplishing business results through teams

Proficiency in anticipating and resolving problems

High level of proficiency in Word, Excel and PowerPoint, and use of document management tools

Ability to develop relationships and work well with others in demanding situations with a positive attitude

Time and project management skills

Ability to take initiative and drive results

Tolerance for ambiguity

Oral and written communication and presentation skills

Amgen provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow.

Amgen focuses on areas of high unmet medical needs and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.