Compass Pathways

Senior Medical Writer (Fixed-Term Contract)

New York, United States · Senior

Work authorization required$135k-$185kDetected 5 days ago

PLCFDA Regulatory

About the role

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.

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

Provides subject matter expertise as a member of the regulatory sciences team
Experience in supporting regulatory submissions as a writer within the pharmaceutical industry/CRO
Knowledge of relevant ICH guidance relating to clinical regulatory documentation
Minimally a Bachelor's degree in the life or health sciences; MSc or PhD preferred
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
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

For an overview of our benefits package and compensation information, please visit " Working at Compass ".
【Base salary per annum】:
$135,000 - $185,000 USD

For an overview of our benefits package and compensation information, please visit " Working at Compass ".
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 who are suffering with mental health conditions and who are not helped by current treatments.
We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways.

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.
UK applicants
We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010).
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.
US applicants
Compass Pathways is proud to be an 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 (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law.
We 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.

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

This listing is sourced directly from Compass Pathways's careers page and normalized into a canonical job model.