Clinical Document Author - Remote

About the role

We are seeking an experienced Medical Writer / Clinical Document Author to develop, review, and evaluate clinical and regulatory documents while ensuring scientific accuracy, regulatory compliance, and high-quality medical writing.

Responsibilities

• Author and review Clinical Study Reports (CSRs) and other regulatory documents.
• Interpret clinical protocols and ensure compliance with ICH guidelines.
• Verify scientific accuracy using source data, TFLs (Tables, Figures, and Listings), and study documentation.
• Review safety documentation, including DSURs and PSURs/PBRERs.
• Provide structured feedback and collaborate with cross-functional teams.
• Support AI-assisted documentation evaluation and quality improvement initiatives.

Requirements

• Regulatory Medical Writing
• Clinical Study Report (CSR) Authoring
• ICH E3 Guidelines
• Scientific Accuracy Assessment
• Source Data Verification
• Clinical Protocol Interpretation
• TFL Analysis
• eCTD Knowledge
• Strong Written Communication & Collaboration

Qualifications

The ideal candidate will have 5+ years of regulatory medical writing experience in a Sponsor, CRO, or consulting environment, with experience authoring Clinical Study Reports and regulatory documentation. A strong knowledge of ICH E3, ICH E2F, ICH E2C, and eCTD requirements is required. An advanced degree in Life Sciences, Pharmacy, Medicine, or a related field (MD, PharmD, PhD, or MSc) is necessary. Experience in oncology and haematology is preferred.

Pay

The pay for this position is $50–$80/hour.