Global Labeling Manager, Biosimilars

Recruiter
Amgen
Location
Thousand Oaks, California
Posted
Sep 11, 2019
Closes
Sep 16, 2019
Ref
c48d000fc3d6
Sector
Law
Organization Type
Corporate
Amgen is seeking a Global Labeling Manager, Biosimilars 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 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 biosimilar 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 Global Labeling Manager, Biosimilars include:
  • Authors and maintains biosimilar core labeling documents including Core Biosimilar Reference Document (CBRD), core Instructions for Use (cIFU), development Core Instructions for Use (dIFU), and United States Prescribing Information (USPI).
  • Chairs/leads Labeling Working Group and presentations to Cross-Functional Executive Labeling Board meetings.
  • Advises internal and/or external experts on the creation of high quality documents supporting changes to the biosimilar 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.
  • Reviews, provides feedback, and approves labeling deviations.
  • Ensures process deviations from labeling procedures and policies are escalated appropriately.
  • Assists in preparation of responses to biosimilar labeling-related Health Authority queries.
  • Incorporates feedback from Human Factors Engineering (HFE) studies into the core IFU and associated labeling.
  • Works with HFE and other subject matter experts to author development and core IFU.
  • Authors Dear Health Care Provider (DHCP) letters.
  • Domestic and international travel 10%.


Basic Qualifications

Doctorate degree

OR

Master's degree and 3 years of Pharmaceutical/Biotech or CRO industry experience

OR

Bachelor's degree and 5 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
  • Previous experience working in industry in support of biosimilars in Global Labeling, Regulatory, or Safety
  • Accomplish business results through teams
  • Proficiency in anticipating and resolving problems
  • 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
  • Degree in pharmaceuticals, natural science or medicine


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.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status

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.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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