Clinical Regulatory Writer (associate Director Or Manager)

AstraZeneca

Boston, MA, US
Base: $133,042.40 - $199,563.60 usd annually for a...
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 across a portfolio of drug development projects

Job Summary

  • This role involves independently managing complex clinical regulatory writing activities across a portfolio of drug development projects.
  • The position requires providing strategic communications leadership to establish standards and advocate for quality and efficiency within the team.
  • Candidates will benefit from eligibility for short-term incentive bonuses, equity-based awards, and comprehensive health and retirement benefits.

Matching Summary

This role involves independently managing complex clinical regulatory writing activities across a portfolio of drug development projects.

Salary

Base: $133,042.40 - $199,563.60 USD annually for Associate Director; $113,293.60 - $169,940.40 USD annually for Manager; Incentives: Short-term bonuses and equity available

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
  • Hybrid work requiring 3 days onsite weekly
  • Strategic communications leadership capabilities

Nice-to-have

  • Advanced degree in scientific discipline (Ph.D.)
  • Experience leading clinical submission NDA/BLA/MAA
  • Experience developing clinical submission communication strategy
  • Experience with CSR and CTD module 2 summaries

Key Requirements

  • BS Life Sciences degree required
  • 7+ years experience for Associate Director level
  • 2-7+ years experience for Manager level
  • In-depth knowledge of regulatory requirements
  • Ability to lead internal and external authoring teams

Work Rights

Not specified

Tailored Resume

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