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
The role involves independently managing complex clinical regulatory writing activities and authoring strategically important documents for drug development

Job Summary

  • The role involves independently managing complex clinical regulatory writing activities and authoring strategically important documents for drug development.
  • Candidates will provide strategic communications leadership, drive the development of clinical submission strategies, and lead internal and external authoring teams.
  • The position offers a competitive annual base pay ranging from $113,293.60 to $199,563.60 USD depending on the level, along with incentives and comprehensive benefits.

Matching Summary

The role involves independently managing complex clinical regulatory writing activities and authoring strategically important documents for drug development.

Salary

Base: $133,042.40 - $199,563.60 USD (Associate Director); $113,293.60 - $169,940.40 USD (Manager); Bonus/Equity: Eligible for short-term incentive bonuses and equity-based awards; 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 submission NDA/BLA/MAA
  • Strategic thinking and review capabilities
  • Continuous improvement mindset
  • Collaboration across global functions

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter