COMPANY INTRODUCTION:

Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, and has offices in New York City and San Francisco in the US. We focus on developing innovations that can improve the lives of those who are suffering with mental health challenges and who are not helped by current treatments.
We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthetic psilocybin (which has received breakthrough therapy designation from the FDA) is administered with psychological support. We are currently in phase 3 study for treatment-resistant depression (TRD), and phase 2 for both post-traumatic stress disorder and anorexia nervosa. Our vision is a world of mental wellbeing - Compass Pathways.
Job overview:
The Technical Writer, CMC will be responsible for document writing, authoring, and compiling of CMC reports and the CMC sections for regulatory (NDA) filings. This position will work closely with the cross-functional teams within Quality, Clinical and Regulatory Affairs to ensure all CMC technical writing objectives are met.
Location: Hybrid in our New York City office or remote on the East Coast, USA.
Reports to: Vice-President, Manufacturing and Supply.

(Include but are not limited to):

• Author and/or review technical reports as required by CMC staff
• Author, compile, and manage CMC sections of regulatory submissions (IND/NDA)
• Effectively manage the integrated drafting and reviewing process to meet appropriate timelines
• Ensure all documents comply with regulatory guidelines, company standards, and industry best practices
• Work closely with cross-functional teams to gather input and feedback for report content and formatting
• Organize and maintain document storage to ensure easy access to reports and related documentation