Remote Medical Writer: Clinical & Regulatory Docs

REV Clinical; United States; Remote; USD 80,000 - 120,000; Full time

Job summary

REV Clinical is seeking a remote Medical Writer with 3–6 years of experience to independently prepare, review and finalize clinical and regulatory documents from concept to submission. The role collaborates with Project Management, Data Management, Biostatistics, Medical Monitoring and QA to ensure timely, high-quality outputs in line with ICH-GCP and regulatory standards.

The position offers a fully remote setup with international operations and opportunities to contribute to regulatory

Qualifications

• Degree in Life Sciences, Pharmacy, Medicine or related field; advanced degree preferred.
• 3–6 years of medical writing experience in CRO/pharma/biotech.
• Experience drafting Protocols, ICFs, IBs and concept sheets.
• Experience with Module 2 overviews and regulatory submissions.
• Knowledge of ICH-GCP and global regulatory guidelines (FDA/EMA/CDSCO).

Responsibilities

• Act as primary contact for medical writing projects at REV Clinical.
• Independently prepare, review and finalize study documents (protocols, ICF, IB).
• Prepare regulatory materials including briefing documents and regulatory submissions.
• Develop SEC presentations and manuscripts for publications.
• Collaborate with cross-functional teams to ensure on-time delivery.

Skills

Medical writing

Regulatory writing

ICH-GCP familiarity

Scientific communication

Remote work autonomy

Education

Life Sciences degree

Tools

Regulatory documentation tools

Job description

REV Clinical is seeking a remote Medical Writer with 3–6 years of experience to independently prepare, review and finalize clinical and regulatory documents from concept to submission. The role collaborates with Project Management, Data Management, Biostatistics, Medical Monitoring and QA to ensure timely, high-quality outputs in line with ICH-GCP and regulatory standards.

The position offers a fully remote setup with international operations and opportunities to contribute to regulatory