Director/Senior Director, Medical Writing
New
United StatesFull-TimeDirector
Salary not disclosed
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Job Details
- Experience
- 12–15+ years of medical writing experience
Requirements
- Advanced degree (MS, PhD, PharmD, MD, or equivalent) preferred.
- 12–15+ years of medical writing experience in industry, CRO, or related environment.
- Extensive experience preparing clinical and regulatory documents supporting INDs and NDAs/BLAs.
- Demonstrated leadership of complex cross-functional writing projects.
- Experience managing medical writing teams and external vendors.
- Exceptional scientific writing and editing ability.
- Expert knowledge of ICH guidelines and global regulatory submission standards.
- Familiarity with FDA and EMA expectations.
- Experience with word templates, eCTD, and document management systems.
Responsibilities
- Provide strategic leadership and oversight of the Medical Writing function.
- Establish document standards, templates, style guides, and best practices.
- Oversee document planning, timelines, and resource allocation.
- Manage external medical writing vendors and consultants.
- Serve as medical writing lead for major development programs.
- Lead preparation and review of clinical protocols, CSRs, IBs, and safety narratives.
- Collaborate with cross-functional teams to ensure clear, compliant scientific communications.
- Provide strategic input into regulatory submissions (IND, NDA/BLA, MAA).
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