24 days old

Regulatory Labeling Sr Associate

Amgen
Thousand Oaks, CA 91360
  • Job Code
    120135306
Amgen

Job ID: R-99191
Location: Thousand Oaks, CA, US 91360

Amgen is seeking a Labeling Strategist, Sr Associate 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, Associate is responsible for supporting of the end-to-end labeling processes for the pre & post marketed products over the products life cycle. The Labeling Strategist, Associate will support the team in 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:
  • Supports creation (user friendly, international language, consistent across products) and maintenance of core labeling documents including cCDS, cPIL, and cIFU in addition to dCDS, dIFU, USPI, and medguide
  • Provides support to more senior strategists in Labeling Working Group.
  • Supports research for guidance on labeling regulations, requirements, competitor labeling, and labeling trends as assigned by TAL
  • Assists in the creation of high quality documents supporting changes to the core documents with internal and/or external experts and manages the annotations within those documents.
  • Assists the senior Strategists in collaborating with customer experience, human factors to create layouts with appropriate placement, meaning and tone.
  • Supports the incorporation of 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.
  • Supports HF studies in evaluation of participants output during the studies.
  • Supports creation of target product labeling.
  • Supports the review and approval of core DHCP letters.
  • Amount of travel required 10%


Knowledge and Skills:
  • Demonstrated ability to work independently and within teams
  • Interpersonal, organizational and negotiation skills.
  • Strong technical writing skills
  • Meeting facilitation and presentation skills
  • Analytical thinking
  • Attention to detail, time management, organizational skills
  • Proficiency utilizing Microsoft Suite - Outlook, Word, Excel, PowerPoint


Basic Qualifications:

Master's degree

OR

Bachelor's degree and 2 years of related experience

OR

Associate's degree and 6 years of related experience

OR

High school diploma / GED and 8 years of related experience

Preferred Qualifications:
  • Degree in pharmaceuticals, natural science or medicine
  • Verbal, and written communication skills.
  • Demonstrable conflict resolution and negotiation skills Applies expert of labeling within a Therapeutic Area
  • Knowledge of FDA, EMEA, and other international regulations for labeling
  • Strong collaboration, presentation, communication, interpersonal, and leadership skills


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.



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

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Regulatory Labeling Sr Associate

Amgen
Thousand Oaks, CA 91360

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