Director of Medical Writing
Job Description:
- Manage (80%) medical writers, including in-house FTEs, contractors, and external vendors
- Author (20%) content and project manage SME contribution for regulatory submissions
- Primary author of phase 1-4 protocols, IBs, CSRs, master ICFs, eCTD modules for INDs and BLAs
- Collaborate with project teams to ensure project deadlines are met
- Mentor less experienced medical writers and provides training to support medical writers and cross-functional teams
Requirements:
- Bachelor’s degree in a scientific or clinical discipline or related field required; Ph.D. preferred
- Minimum of 7 years of related, sponsor-level pharma or biotech clinical/regulatory medical writing experience required; CRO experience considered
- Native/bilingual or fluent American English proficiency
- eCTD Module 5 and Module 2 writing experience for global MAAs
- Knowledgeable in the regulatory guidances developed for documents authored by medical writing
- Ability to proofread documents for compliance with internal and external guidance documents
Benefits:
- Comprehensive benefits package
- Health benefits
- Retirement savings plans
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