Associate Director, Medical Writing

argenx

United States
Base: $164,000.00 - $225,500.00 usd annually; bonu...
Fully remote
5 years sponsor-level pharma experience
Native/bilingual american english proficiency
Ectd module 2 and module 5 writing experience
The role involves serving as a primary author for complex clinical, nonclinical, and safety documents required for regulatory submissions including INDs and BLAs

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 manage in-house medical writers, contractors, and external vendors while ensuring standardization through templates and style guides.
  • The position offers a competitive annual base salary range of $164,000.00 to $225,500.00 USD along with short-term and long-term incentive programs.

Matching Summary

The role involves serving as a primary author for complex clinical, nonclinical, and safety documents required for regulatory submissions including INDs and BLAs.

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 pharma experience
  • Native/bilingual American English proficiency
  • eCTD Module 2 and Module 5 writing experience
  • Phase 1-4 protocol and CSR authoring
  • Regulatory submission document expertise

Nice-to-have

  • Familiarity with Veeva Vault preferred
  • Pharmacovigilance documents knowledge
  • Strong preference for East Coast location
  • Experience managing external vendors
  • Inspection-readiness facilitation skills

Key Requirements

  • Bachelor's degree required; PhD preferred
  • Minimum 5 years related experience
  • Fluent American English proficiency
  • US work authorization (implied by US salary)
  • East Coast location preference

Work Rights

Not specified

Tailored Resume

Cover Letter