Lead Medical Writer, Regulatory (Remote/Hybrid)

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

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.