Clinical Regulatory Writer (associate Director Or Manager)

AstraZeneca

Boston, MA, US
Base: $133,042.40 - $199,563.60 usd (associate dir...
3d onsite
Bs life sciences degree or similar
7+ years medical writing experience for associate director
2-7+ years medical writing experience for manager
This role involves independently managing complex clinical regulatory writing activities and authoring strategically important documents to align with project strategies

Job Summary

  • This role involves independently managing complex clinical regulatory writing activities and authoring strategically important documents to align with project strategies.
  • The position offers the opportunity to drive the development of clinical submission communication strategies and lead internal and external authoring teams.
  • Employees benefit from a hybrid work model requiring three days onsite, along with eligibility for short-term incentives, equity-based awards, and comprehensive health coverage.

Matching Summary

This role involves independently managing complex clinical regulatory writing activities and authoring strategically important documents to align with project strategies.

Salary

Base: $133,042.40 - $199,563.60 USD (Associate Director); Base: $113,293.60 - $169,940.40 USD (Manager); Bonus/Equity: Short-term incentive bonuses and equity-based awards available; Benefits: Qualified retirement programs, paid time off, health/dental/vision coverage

Skills & Requirements

Must-have

  • BS Life Sciences degree or similar
  • 7+ years medical writing experience for Associate Director
  • 2-7+ years medical writing experience for Manager
  • In-depth knowledge of regulatory requirements
  • Ability to lead communication projects

Nice-to-have

  • Advanced degree in scientific discipline (Ph.D.)
  • Experience leading clinical submissions like NDA/BLA/MAA
  • Strategic thinking and review capabilities
  • Experience with CSR and CTD module 2 summaries
  • Proactive collaboration across functions

Key Requirements

  • Associate Director: 7+ years experience
  • Manager: 2-7+ years experience
  • BS Life Sciences degree required
  • Hybrid work arrangement (3 days onsite)

Work Rights

Not specified

Tailored Resume

Cover Letter