Amgen

Labeling Process Management, Sr. Associate

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Aug 14, 2019
Ref
R-80575
Required Education
High School or equivalent
Position Type
Full time
Amgen is seeking a Labeling Process Management, Sr. Associate to join our team and work from our beautiful campus in Thousand Oaks, CA. To learn more about this position:

This opportunity is a part of Global Labeling Group, and under the supervision of the Global Labeling Process Management Director, the Labeling Process Management, Sr. Associate is responsible for supporting the Labeling Process Management activities for US.

Regional labeling operational support, including:
  • Creation of Source Text for Mock-ups and Master labeling
  • Support RTQs for Source Text
  • Responsible for management of initial and final SPL
  • Responsible for submissions of new labeler codes
  • Maintain NDC Code Listing and De-Listing
  • Update and complete tasks within Global Labeling tracking tool for US labeling
  • Triage requests through the Global Labeling tracking tool for timeline waivers and deviations from core or reference label content


Basic Qualifications:

Master's degree

OR

Bachelor's degree and 2 years of Regulatory affairs, Labeling or related scientific experience

Regulatory affairs, Labeling or

OR

Associate's degree and 6 years of Regulatory affairs, Labeling or related scientific experience

OR

High school diploma / GED and 8 years of Regulatory affairs, Labeling or related scientific experience

Preferred Qualifications:
  • Previous experience working in industry in support of Global Labeling, Regulatory, Engineering or Quality Management/Quality Engineering
  • Works well independently and within teams
  • Use of document management tools
  • Ability to develop relationships and work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy and respect
  • Time and project management skills
  • Ability to take initiative and drive results
  • Tolerance for ambiguity
  • Proficiency in anticipating and resolving problems
  • 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.

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.