Labeling Process Management, Sr. Associate (Open to remote)

HOW MIGHT YOU DEFY IMAGINATION?

You've earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you've worked hard to acquire and the passion you already have. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Labeling Process Management, Sr. Associate

Live

What you will do

Let's do this. Let's change the world. In this vital role you will support the labeling process management activities for US.

Responsibilities:

  • 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
  • This role is open to remote.


Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Labeling professional we seek is a leader with these qualifications.

Basic Qualifications:

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


Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
  • Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
  • A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan-comprising health, finance and wealth, work/life balance, and career benefits-with compensation and benefits rated above 4 stars (out of 5) on Glassdoor


Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

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.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

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