Clinical Regulatory Writer, Associate Director / Manager

aerzteforum.info

Gaithersburg, MD, US
Base: $133,042.40 - $199,563.60 usd annual; bonus/...
3d onsite
7+ years medical writing experience
Bs life sciences degree required
Lead internal/external authoring teams
This role involves independently managing complex clinical regulatory writing activities across a portfolio to translate life-changing science into medicines

Job Summary

  • This role involves independently managing complex clinical regulatory writing activities across a portfolio to translate life-changing science into medicines.
  • The position requires providing strategic communications leadership, including driving the development of Clinical Submission Communication Strategies for successful submissions.
  • Candidates will benefit from a supportive environment focused on professional growth, agility, and collaboration within AstraZeneca's diverse global team.

Matching Summary

This role involves independently managing complex clinical regulatory writing activities across a portfolio to translate life-changing science into medicines.

Salary

Base: $133,042.40 - $199,563.60 USD Annual; Bonus/Equity: Eligible for short-term incentives and equity-based awards; Benefits: Qualified retirement programs, paid time off, health/dental/vision coverage

Skills & Requirements

Must-have

  • 7+ years medical writing experience
  • BS Life Sciences degree required
  • Lead internal/external authoring teams
  • Hybrid work model 3 days onsite
  • Strategic communications leadership

Nice-to-have

  • Advanced degree in scientific discipline
  • Experience with vendor medical writers
  • Drive continuous improvement initiatives
  • Support development of junior managers

Key Requirements

  • Associate Director level: 7+ years experience
  • Manager level: 2-7+ years experience
  • BS Life Sciences degree or similar
  • In-depth knowledge of regulatory requirements

Work Rights

Not specified

Tailored Resume

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