Remote Medical Writer for CSRs & Regulatory Docs

YO AI Labs; San Jose (CA); Remote; USD 69,000 - 110,000; Part time

Job summary

YO AI Labs seeks a 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.

The role involves authoring CSRs and other regulatory documents, interpreting clinical protocols per ICH guidelines, verifying data with source documents and TFLs, reviewing safety documents such as DSURs and PSURs, and collaborating with cross-functional teams.

Qualifications

• 5+ years of regulatory medical writing experience in a Sponsor, CRO, or consulting environment.
• Experience authoring Clinical Study Reports and regulatory documentation.
• Strong knowledge of ICH E3, ICH E2F, ICH E2C, and eCTD requirements.

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

Tools

ICH E3 Guidelines

Job description

YO AI Labs seeks a 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.

The role involves authoring CSRs and other regulatory documents, interpreting clinical protocols per ICH guidelines, verifying data with source documents and TFLs, reviewing safety documents such as DSURs and PSURs, and collaborating with cross-functional teams.