Associate Director, Medical Writing

argenx

Remote, US
Base: $164,000.00 - $225,500.00 usd annually; bonu...
Fully remote
5+ years sponsor-level medical writing experience
Native/bilingual american english proficiency
Ectd module 2 and module 5 writing expertise
argenx is seeking an Associate Director of Medical Writing to contribute to the development of complex regulatory documents and enhance the medical writing department. The role requires extensive experience in clinical and regulatory writing within a biotech or pharmaceutical setting, ideally with a focus on eCTD submissions. The position offers a fully remote work environment and a competitive salary range

Job Summary

  • The role involves serving as a primary author for complex clinical, nonclinical, and safety documents required for regulatory submissions including INDs and BLAs.
  • Candidates will be responsible for managing medical writers, standardizing documents using templates and style guides, and ensuring inspection readiness across all programs.
  • The position offers a competitive base salary range of $164,000.00 to $225,500.00 USD along with short-term and long-term incentive programs.

Matching Summary

Match Score: 85

argenx is seeking an Associate Director of Medical Writing to contribute to the development of complex regulatory documents and enhance the medical writing department. The role requires extensive experience in clinical and regulatory writing within a biotech or pharmaceutical setting, ideally with a focus on eCTD submissions. The position offers a fully remote work environment and a competitive salary range.

Salary

Base: $164,000.00 - $225,500.00 USD annually; Bonus/Equity: Eligible for short-term and long-term incentive programs; Benefits: Comprehensive package including retirement savings and health benefits

Skills & Requirements

Must-have

  • 5+ years sponsor-level medical writing experience
  • Native/bilingual American English proficiency
  • eCTD Module 2 and Module 5 writing expertise
  • Experience with INDs and BLA submissions
  • Ability to manage in-house writers and vendors

Nice-to-have

  • Familiarity with Veeva Vault preferred
  • Pharmacovigilance document experience
  • East Coast location preference
  • PhD in scientific discipline
  • Inspection-readiness facilitation skills

Key Requirements

  • Bachelor's degree required; PhD preferred
  • Minimum 5 years of sponsor-level pharma/biotech experience
  • Fluent American English proficiency
  • Strong preference for East Coast location

Work Rights

Not specified

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