Medical Writer - Immuno-Oncology
Location: Waltham, MA (On-site)
Contract: 12 months (Potential to Extend)
A growing clinical-stage biotech company is seeking an experienced Medical Writer to support the preparation and submission of regulatory and research documentation within the immuno-oncology space. This individual will collaborate with R&D and functional leads to draft, edit, and review key documents including INDs, Investigator's Brochures, clinical study reports, and manuscripts.
Responsibilities:
- Draft high-quality PIND/IND documents and research manuscripts
- Translate complex immuno-oncology data into clear regulatory content
- Coordinate review cycles and lead quality control for submissions
- Ensure consistency and compliance with ICH/FDA standards
- Develop and maintain documentation systems and templates
Qualifications:
- MS required; PhD preferred
- 8-10+ years of medical/scientific writing experience
- Strong understanding of immunology or immuno-oncology data
- Proven ability to manage multiple deliverables under tight timelines
- Excellent editing and peer-review coordination skills