Director Of Medical Writing

Argenx

Remote
Base: $212,000.00 - $291,500.00 usd; bonus/equity:...
Remote
Manage medical writers
Author regulatory content
Develop departmental strategy
Argenx is seeking a Director of Medical Writing to lead and manage medical writers while authoring regulatory documents for its innovative pipeline focused on autoimmune diseases. This remote position requires extensive medical writing experience and a strong understanding of regulatory processes

Job Summary

  • Manage medical writers (in-house FTEs, contractors, and external vendors) who are individually contributing to the MW activities for a variety of regulatory documents.
  • Author content and project manage SME contribution to develop content for regulatory submissions that is well-organized, consistent, accurate, and compliant with argenx MW standards, company SOPs, style guide, lexicon, templates, and libraries.
  • Mentors less experienced medical writers and develops and implements training to support medical writers and cross-functional teams.

Matching Summary

Match Score: 85

Argenx is seeking a Director of Medical Writing to lead and manage medical writers while authoring regulatory documents for its innovative pipeline focused on autoimmune diseases. This remote position requires extensive medical writing experience and a strong understanding of regulatory processes.

Salary

Base: $212,000.00 - $291,500.00 USD; Bonus/Equity: Not specified; Benefits: Comprehensive benefits package

Skills & Requirements

Must-have

  • manage medical writers
  • author regulatory content
  • develop departmental strategy
  • inspection-readiness of activities
  • eCTD Module 5 and Module 2 writing

Nice-to-have

  • inspire and grow company
  • solution-focused and experience leading teams
  • work beyond existing methodologies

Key Requirements

  • Bachelor’s degree in a scientific or clinical discipline
  • Minimum of 7 years of related, sponsor-level pharma or biotech clinical/regulatory medical writing experience
  • Native/bilingual or fluent American English proficiency

Work Rights

Not specified

Tailored Resume

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