About the Opportunity
We are seeking a highly experienced Medical Writer to support clinical development programs on a part-time basis. This is an ideal opportunity for a seasoned regulatory medical writer looking for meaningful work with a growing and well-funded team.
Key Responsibilities
- Author and edit clinical protocols and protocol amendments for Phase 1 and Phase 2 CNS trials.
- Write and review Clinical Study Reports (CSRs) in accordance with ICH E3 guidelines.
- Collaborate closely with clinical, regulatory, biostatistics, and medical affairs teams.
- Work independently with minimal oversight to meet tight submission timelines.
- Ensure all documents meet regulatory standards and internal quality requirements.
Qualifications
- 15+ years of medical writing experience in the pharmaceutical or biotechnology industry.
- Deep expertise in CNS therapeutic areas, with neurology, psychiatry, or sleep disorders preferred.
- Strong track record authoring clinical protocols and CSRs for regulatory submissions.
- Experience working as an independent consultant or freelancer preferred.
- Excellent communication skills and ability to manage multiple priorities.
- Advanced degree in life sciences, pharmacy, or a related field preferred.
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