Senior Medical Writer

Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We focus on developing novel treatments that have the potential to improve the lives of those suffering with mental health conditions who are not helped by current treatments. Our investigational COMP360 synthetic psilocybin treatment has Breakthrough Therapy designation from the FDA and Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). We are currently in phase 3 for TRD, with completed phase 2 studies for PTSD and anorexia nervosa, and are planning further late-stage studies.

About the role

The Senior Medical Writer is responsible for developing clinical regulatory documents related to our investigational COMP360 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.

Location: Hybrid in New York City or remote on the U.S. East Coast. Duration: 6-month contract.

Responsibilities

• Prepares and coordinates 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 relevant guidance and best practices
• Oversees and coordinates 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

Requirements

• Bachelor’s degree in life or health sciences; MSc or PhD preferred
• Experience in supporting regulatory submissions as a writer within the pharmaceutical industry or CRO
• Experience leading the development of clinical documents as part of a multi-functional team, including CSRs, IBs, and clinical summaries (ISS/ISE)
• Broad working knowledge of the clinical drug development process and experience 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
• Strong attention to detail and editorial skills
• Flexibility in adapting to changing circumstances or new information
• Alignment with Compass Pathways’ company culture and values

Pay

Base salary range: $135,000 – $185,000 USD per annum. Individual total compensation varies based on qualifications, skill level, competencies, and work location. Additional discretionary bonuses and equity may be available.

Benefits

For an overview of our benefits package and compensation information, visit Working at Compass.