Principal Medical Writer (Contract)

Compass Pathways • New York City, NY

31d • Hybrid

About The Position

The Principal Medical Writer at Compass Pathways is responsible for developing various clinical regulatory documents related to our investigational product, our proprietary psilocybin therapy. This person 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
• Considerable experience in regulatory medical writing within the pharmaceutical/medical 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

• 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

What This Job Offers

• Career Level: Principal
• Number of Employees: 101-250 employees