Senior Medical Writer (Fixed-Term Contract)

Job Overview 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. Location: Hybrid in our New York City office or remote on the east coast in the United States. Reports to: Director, Medical Writing. Duration: 6-month contract. Roles and 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 the relevant guidance and best practice. 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. Candidate Profile Minimum a Bachelor's degree in 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. Compensation (NYC) Base salary per annum: $135,000 - $185,000 USD. Base pay is part of the Total Package, which may include discretionary bonuses and equity. Benefits & Compensation For an overview of our benefits package and compensation information, please visit "Working at Compass". Equal Opportunities & Reasonable Accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. Diversity & Inclusion US applicants: Compass Pathways is a proud equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex, ethnicity, age, or disability. UK applicants: We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. #J-18808-Ljbffr