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, with offices in New York City in the US. They focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments.

They are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of their investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area.

They are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. They envision a world where mental health means not just the absence of illness but the ability to thrive.

The Senior Medical Writer at Compass Pathways is responsible for developing various clinical regulatory documents related to their investigational product, their 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.

Location: Hybrid in their New York City office or remote on the east coast in the United States.

Reports to: Associate Director, Medical Writing.

Roles and responsibilities include:

• 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 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

For an overview of the benefits package and compensation information, please visit "Working at Compass" on their website.

Compass Pathways is committed to building a workplace where everyone’s wellbeing matters. They provide reasonable accommodations during the interview process as needed.

They are proud of their commitment to diversity and equality pursuant to the Equality Act 2010 in the UK and provide equal employment opportunity in the US based on business needs, job requirements, and qualifications without discrimination based on protected characteristics.

Unfortunately, they cannot sponsor employment visas and can only accept applications if candidates have employment rights in the country they are applying to.

All data is confidential and protected by legal and data privacy requirements according to their recruitment Privacy Notice.