Senior Medical Writer (Fixed-Term Contract)

Job Description

Job Description

Company introduction:

Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care.

The Company is headquartered in London, UK, with a U.S. office in New Jersey. We believe mental health patients deserve the possibility of a better future. Our initial focus is developing COMP360 psilocybin, a proprietary, investigational, synthetic psilocybin treatment under evaluation for treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD). COMP360 is a potentially first-in-class treatment and has Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA), as well as Innovative Licensing and Access Pathway (ILAP) designation in the UK for TRD.

We are leading the world's largest classic psychedelic clinical program in TRD, and building upon that robust foundation, we are executing a late-stage trial evaluating COMP360 for PTSD, another condition with high unmet need. Our goal is to advance treatments that move the field of psychiatry towards treatment options that offer rapid onset and sustained durability with infrequent dosing. - Compass Pathways

Job overview:

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.

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

Reports to : Director, Medical Writing.

Duration: 6-month contract.

Roles and responsibilities
( Include but are not limited to ):

• Prepares and co-ordinates responses to regulatory agency information requests
• 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
• Experience in supporting regulatory submissions as a writer within the pharmaceutical 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

Compensation Description (annually):

Our compensation package for permanent hires includes base salary, discretionary bonus, and equity, alongside our comprehensive benefits offering.

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 salary per annum】:

$135,000—$185,000 USD

Benefits:

For an overview of our benefits package and compensation information, please visit "Joins us - Our Benefits".

These include flexibility & generous time off, parental & reproductive support, health & medical, mental health & wellbeing and Financial health.

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.