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Compass Pathways · 3 weeks ago

Principal Medical Writer (Contract)

New York, United States

Contract

Hybrid

Lead/Staff

$160K/yr - $205K/yr

Compass Pathways plc is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Principal Medical Writer is responsible for developing clinical regulatory documents related to the company's investigational psilocybin therapy, ensuring compliance with regulatory standards and collaborating with multidisciplinary teams.

BiotechnologyHealth CareLife ScienceMental HealthPersonal HealthWellness

Growth Opportunities

No H1B

Responsibilities

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

Qualification

Regulatory medical writingClinical document developmentICH guidance knowledgeLifeHealth sciences degreeAttention to detailClear writing skillsFlexibilityTeam collaboration