Remote Contract: Regulatory Medical Writer — CSR Expert

YO AI Labs; Phoenix (AZ); Remote; USD 69,000 - 110,000; Part time

Job summary

YO AI Labs, in a remote contractor engagement, seeks an experienced Medical Writer / Clinical Document Author to develop, review, and evaluate clinical and regulatory documents with scientific accuracy and regulatory compliance.

The role involves authoring CSRs, interpreting protocols per ICH E3, and reviewing safety documentation (DSURs/PSURs/PBRERs). You will provide structured feedback and support AI-assisted quality initiatives.

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

Written Communication & Collaboration

Education

Advanced degree in Life Sciences, Pharmacy, Medicine, or related field (MD, PharmD, PhD, MSc)

Job description

YO AI Labs, in a remote contractor engagement, seeks an experienced Medical Writer / Clinical Document Author to develop, review, and evaluate clinical and regulatory documents with scientific accuracy and regulatory compliance.

The role involves authoring CSRs, interpreting protocols per ICH E3, and reviewing safety documentation (DSURs/PSURs/PBRERs). You will provide structured feedback and support AI-assisted quality initiatives.