Remote Medical Writer: Regulatory CSR & Clinical Docs Expert

YO AI Labs; Atlanta (GA); Remote; USD 69,000 - 110,000; Full time

Job summary

YO AI Labs is seeking an experienced Medical Writer / Clinical Document Author to develop, review, and evaluate clinical and regulatory documents while ensuring scientific accuracy and regulatory compliance.

The role focuses on authoring CSRs, interpreting protocols per ICH guidelines, and supporting AI‑assisted documentation quality initiatives within a remote contract setting. Strong written communication and collaboration are essential for success in this role.

Qualifications

• 5+ years of regulatory medical writing experience.
• Experience authoring Clinical Study Reports and regulatory documentation.
• Strong knowledge of ICH E3, ICH E2F, ICH E2C, and eCTD requirements.
• Oncology and haematology experience is preferred.

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.

Skills

Regulatory Medical Writing

CSR Authoring

ICH E3 Guidelines

Scientific Accuracy Assessment

Source Data Verification

Clinical Protocol Interpretation

TFL Analysis

eCTD Knowledge

Strong Written Communication

Education

Advanced degree in Life Sciences/Medicine

Job description

YO AI Labs is seeking an experienced Medical Writer / Clinical Document Author to develop, review, and evaluate clinical and regulatory documents while ensuring scientific accuracy and regulatory compliance.

The role focuses on authoring CSRs, interpreting protocols per ICH guidelines, and supporting AI‑assisted documentation quality initiatives within a remote contract setting. Strong written communication and collaboration are essential for success in this role.