Principal Medical Writer (Contract) at Compass Pathways

New York, New York, United States -

Full Time

Start Date

Immediate

Expiry Date

06 Mar, 26

Salary

205000.0

Posted On

06 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Medical Writing, Regulatory Documents, Clinical Trials, Attention to Detail, Team Collaboration, Clinical Drug Development, ICH Guidance, Clear Writing, Subject Matter Expertise, Quality Management, Data Integrity, Ethical Standards, Flexibility, Clinical Summaries, Protocols, Investigational Products

Industry

Mental Health Care

Description

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, with offices in New York City in the US. 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 are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our 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. 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. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways. Job overview: The Principal Medical Writer at Compass Pathways is responsible for developing various clinical regulatory documents related to our investigational product, our 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 our New York City office or remote on the east coast in the United States. Reports to: Associate Director, Medical Writing. Duration: 12-month contract. Roles and responsibilities Responsibilities include (but are not limited to): 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 co-ordinates 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: Minimally a Bachelor’s degree in the life or health sciences; MSc or PhD preferred Considerable experience in regulatory medical writing within the pharmaceutical/medical 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 【For NYC】Compensation Description (annually): Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity. 【Base salary per annum】: $160,000—$205,000 USD 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. 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. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

Responsibilities

The Principal Medical Writer is responsible for developing clinical regulatory documents related to the investigational psilocybin therapy. This includes leading document preparation and ensuring compliance with regulatory standards.