Associate Director, Medical Writing

argenx

United States
Base: $164,000.00 - $225,500.00 usd; bonus/equity:...
**
5 years sponsor-level pharma experience
Native/bilingual american english proficiency
Ectd module 2 and module 5 writing
** Argenx is seeking an Associate Director of Medical Writing to contribute to the development of clinical, nonclinical, and safety documents for regulatory submissions in a fully remote work environment. The ideal candidate will have significant experience in medical writing within the pharmaceutical or biotech industry and will play a crucial role in enhancing the medical writing department's infrastructure while ensuring compliance with regulatory standards. **

Job Summary

  • The role involves contributing to the development of complex clinical, nonclinical, and safety documents for regulatory submissions while building critical infrastructure for the department.
  • Candidates will serve as primary authors for phase 1-4 protocols, Investigator Brochures, Clinical Study Reports, and eCTD modules required for INDs and BLAs.
  • The position offers a competitive base salary range of $164,000.00 - $225,500.00 USD along with short-term and long-term incentive programs and comprehensive benefits.

Matching Summary

Match Score: 75

** Argenx is seeking an Associate Director of Medical Writing to contribute to the development of clinical, nonclinical, and safety documents for regulatory submissions in a fully remote work environment. The ideal candidate will have significant experience in medical writing within the pharmaceutical or biotech industry and will play a crucial role in enhancing the medical writing department's infrastructure while ensuring compliance with regulatory standards. **

Salary

Base: $164,000.00 - $225,500.00 USD; Bonus/Equity: Eligible for short-term and long-term incentive programs; Benefits: Comprehensive package including retirement savings plans 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
  • Protocol, IB, CSR, and briefing document authoring
  • Inspection-readiness of medical writing activities

Nice-to-have

  • Familiarity with Veeva Vault preferred
  • Pharmacovigilance document experience preferred
  • Ability to work autonomously in fast-paced environment
  • Experience managing contractors and external vendors
  • Strong preference for East Coast location

Key Requirements

  • Bachelor's degree in scientific or clinical discipline (PhD preferred)
  • Minimum 5 years related sponsor-level clinical/regulatory medical writing experience
  • Fluent American English proficiency required
  • Knowledge of regulatory guidances for medical writing documents

Work Rights

Not specified

Tailored Resume

Cover Letter