29 days old

Regulatory Labeling Manager

Amgen
Thousand Oaks, CA 91360
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  • Job Code
    120135369
Amgen

Job ID: R-99173
Location: Thousand Oaks, CA, US 91360

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

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).

Key Activities 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 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
  • 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
  • Works with customer experience, human factors to create layouts with appropriate placement, meaning and tone
  • Incorporates feedback from 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
  • Support HF studies in evaluation of participants output during the studies.
  • Supports creation of target product labeling
  • Manages the review and approval of core DHCP letters
  • Represents labeling on product-specific global regulatory teams
  • Amount of travel required 10%


Knowledge and Skills:
  • Knowledge of global labeling regulatory requirements, standards and processes
  • Understanding of product development is required, and a solid understanding of biology and pharmacology relevant to the therapeutic area
  • Analytical thinking
  • Ability to develop solutions that are thorough, practical, and consistent with functional objectives.
  • Strong collaboration, interpersonal and negotiation skills.
  • Demonstrable conflict resolution and negotiation skills
  • Meeting facilitation and presentation skills
  • Attention to detail, time management, organizational skills
  • Excellent verbal, and written communication skills.
  • Strong technical writing skills
  • Proficiency utilizing Microsoft Suite - Outlook, Word, Excel, PowerPoint


Basic Qualifications:

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 Qualifications:

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

Understanding the impact of emerging trends and their implications for Amgen

Project Management experience, experience managing individual and group projects of moderate complexity

Strong collaboration, presentation, communication, interpersonal, and leadership skills

Experience working in a Documentum-based document management system

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need 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.

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.

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.



PI120135369
Posted: 2020-05-07 Expires: 2020-06-08

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Regulatory Labeling Manager

Amgen
Thousand Oaks, CA 91360

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