Director of Medical Writing
$212,000–$291,500 year
Remote · New York City, New York, United States or US
Job Summary
The Director of Medical Writing will manage medical writers and author content for regulatory submissions ensuring compliance with argenx standards. This role includes developing departmental strategies, mentoring writers, and contributing to document standardization. Candidates should possess a Bachelor’s degree in a scientific field, with a minimum of 7 years of pharma or biotech medical writing experience. Proficiency in eCTD writing and regulatory guidelines, as well as excellent communication and multitasking skills, are essential.
Required Qualifications
- Bachelor’s degree in a scientific or clinical discipline or related field required
- Minimum of 7 years of related, sponsor-level pharma or biotech clinical/regulatory medical writing experience required
- Native/bilingual or fluent American English proficiency
- Ability to proofread documents for compliance with internal and external guidance documents
- Basic understanding of scientific methodology as applied to drug development
- Excellent written and verbal communication skills
Desired Qualifications
- Ph.D. in a scientific or clinical discipline or related field preferred
- eCTD Module 5 and Module 2 writing experience for global MAAs
- Experience leading teams
- Understanding of regulatory guidance for documents authored by medical writing
Additional Requirements
- Must be proficient in MS Office
- Must work autonomously and collaboratively in a team
- Ability to prioritize and multi-task successfully in a fast-paced environment
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