Medical Writer Contractor-CNS (Home-based)
Job Duties:
- Develop high-quality clinical and regulatory documents: protocols, IBs, CSRs, Module 2 summaries, clinical overviews, and agency briefing books.
- Interpret and synthesize complex clinical data into compelling narratives.
- Collaborate with cross-functional teams including project leads, biostatisticians, and regulatory affairs.
- Lead document review meetings and ensure alignment across stakeholders.
- Oversee outsourced writing projects and manage vendor relationships.
- Ensure compliance with internal SOPs and regulatory standards.
- Support timeline development, document workflows, and QC processes.
Qualifications:
- Advanced degree (MD, PhD, or PharmD) required.
- 6+ years of relevant medical writing experience in pharma/biotech.
- Strong knowledge of GxP and the drug development lifecycle.
- Proven ability to manage multiple projects and meet tight deadlines.
- Excellent communication, collaboration, and organizational skills.
Bonus Points For
- Experience in psychiatric and/or neurological therapeutic areas.
- Familiarity with statistical analysis plans and clinical data outputs.
- Leadership in cross-functional teams and document strategy.
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