Principal Medical Writer (temporary)

Compass Pathways; United States; Hybrid; USD 160,000 - 205,000; Full time

Benefits offered by this job

Discretionary bonuses

Equity options

Comprehensive benefits package

Job summary

A biotechnology company is looking for a Principal Medical Writer to develop clinical regulatory documents. This role involves leading document preparation, ensuring adherence to regulatory standards, and coordinating with multidisciplinary teams. The ideal candidate has a Bachelor's in life sciences, experience in regulatory writing, and excellent attention to detail. The position offers hybrid work options from New York City or remote on the east coast, alongside a competitive salary range of $160,000 – $205,000 per annum.

Qualifications

• Minimally a Bachelor’s degree in the life or health sciences; MSc or PhD preferred.
• Considerable experience in regulatory medical writing.
• Experience in leading development of clinical documents as part of a multi-functional team.

Responsibilities

• Leads preparation of clinical regulatory documents.
• Ensures Compass clinical documents are clear and accurate.
• Coordinates outsourced medical writing services.

Skills

Regulatory medical writing experience

Attention to detail

Excellent written English

Knowledge of ICH guidance

Flexibility

Education

Bachelor’s degree in life or health sciences

MSc or PhD

Job description

1 week ago Be among the first 25 applicants

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

Benefits & Compensation

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

For an overview of our benefits package and compensation information, please visit "Working at Compass".

Equal opportunities

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.

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.

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

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Seniority level

Mid‑Senior level

Employment type

Temporary

Job function

Research

Industries

Biotechnology Research and Pharmaceutical Manufacturing