Regulatory Writing Sr Mgr

Amgen Inc

Base: $152,684.00 - $193,308.00 usd; bonus: discre...
Fully remote
Lead regulatory writing activities for complex submissions
Oversee authoring of clinical study reports and protocols
Mentor junior medical writers and contract staff
This role serves as the functional area lead on product teams, driving regulatory submission strategies for complex drug applications

Job Summary

  • This role serves as the functional area lead on product teams, driving regulatory submission strategies for complex drug applications.
  • The successful candidate will author or oversee documents including Clinical Study Reports, Investigator Brochures, and Pediatric Investigation Plans.
  • Amgen offers a comprehensive benefits package including retirement plans, stock incentives, and flexible work models to support professional growth.

Matching Summary

This role serves as the functional area lead on product teams, driving regulatory submission strategies for complex drug applications.

Salary

Base: $152,684.00 - $193,308.00 USD; Bonus: Discretionary annual bonus program; Benefits: Retirement plan, health coverage, stock-based incentives

Skills & Requirements

Must-have

  • Lead regulatory writing activities for complex submissions
  • Oversee authoring of Clinical Study Reports and Protocols
  • Mentor junior medical writers and contract staff

Nice-to-have

  • Experience in Global Regulatory Team collaboration
  • Ability to generate document timelines independently
  • Strong leadership in cross-departmental initiatives

Key Requirements

  • Doctorate degree with 2 years experience OR Master's with 6 years
  • 5+ years of medical writing experience in Biotech/Pharmaceutical industry
  • Direct experience with regulatory documents in Research or Development

Work Rights

Not specified

Tailored Resume

Cover Letter