Remote Medical Writer for Regulatory CSR & ICH Documents

YO AI Labs; California (MO); Remote; USD 69,000 - 110,000; Part 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, regulatory compliance, and high-quality medical writing.

Key responsibilities include authoring and reviewing CSRs and regulatory submissions, interpreting clinical protocols per ICH guidelines, and ensuring accuracy with source data, TFLs, and study docs; there is collaboration with cross-functional teams and

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.
• Advanced degree in Life Sciences, Pharmacy, Medicine, or a related field (MD, PharmD, PhD, or MSc).
• Experience in oncology and haematology 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 or related field (MD/PhD/PharmD/MSc)

Tools

eCTD Knowledge

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, regulatory compliance, and high-quality medical writing.

Key responsibilities include authoring and reviewing CSRs and regulatory submissions, interpreting clinical protocols per ICH guidelines, and ensuring accuracy with source data, TFLs, and study docs; there is collaboration with cross-functional teams and