Senior Medical Writer (Fixed-Term Contract)
Compass Pathways•New York, NY
•$135,000 - $185,000•Hybrid
About The Position
The Senior Medical Writer is responsible for developing various clinical regulatory documents related to our investigational product, our proprietary psilocybin therapy. This role leads document preparation, ensures adherence to regulatory and company standards, coordinates outsourced writing services, and collaborates with multidisciplinary teams to support the regulatory sciences function.
Requirements
- Minimally a Bachelor’s degree in the life or health sciences; MSc or PhD preferred
- Experience in supporting regulatory submissions as a writer within the pharmaceutical industry/CRO
- Experience in leading the development of clinical documents as part of a multi‑functional team, including CSRs, IBs, clinical summaries, ISS/ISE
- Broad working knowledge of the clinical drug development process with experience of integrating information into clinical regulatory documents
- Knowledge of relevant ICH guidance relating to clinical regulatory documentation
- Excellent written English with aptitude for clear and concise writing
- Excellent attention to detail and editorial skills
- Flexibility in adapting to changing circumstances or new information
- Alignment to our company culture and values
Responsibilities
- Prepares and co-ordinates responses to regulatory agency information requests
- Leads preparation of clinical regulatory documents, including CSRs, protocols, IB and clinical summaries (Module 2.7.x and ISE/ISS)
- Ensures Compass clinical documents are clear, accurate, and written in accordance with the relevant guidance and best practice
- Oversees and co-ordinates outsourced medical writing services as required
- Provides subject matter expertise as a member of the regulatory sciences team
- Accountable for compliance with ethical and scientific standards, regulatory requirements, and the Compass Quality Management System; ensuring participant safety, data integrity and accuracy throughout the trial process
Benefits
- Additional discretionary bonuses
- Equity
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What This Job Offers
Job Type
Full-time
Career Level
Senior
