Medical Writing Consultant

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.