Remote Medical Writer Expert – CSR & Regulatory Docs

YO AI Labs; Austin (TX); On-site; USD 69,000 - 110,000; Full time

Job summary

YO AI Labs is seeking an experienced Medical Writer Expert to develop, review, and evaluate clinical and regulatory documents remotely as a contractor. The role emphasizes scientific accuracy, regulatory compliance, and collaboration with cross-functional teams.

You will author CSRs, interpret protocols, verify data against source documents, review safety reports, and contribute to AI-assisted documentation quality initiatives.

Qualifications

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

Education

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

Job description

YO AI Labs is seeking an experienced Medical Writer Expert to develop, review, and evaluate clinical and regulatory documents remotely as a contractor. The role emphasizes scientific accuracy, regulatory compliance, and collaboration with cross-functional teams.

You will author CSRs, interpret protocols, verify data against source documents, review safety reports, and contribute to AI-assisted documentation quality initiatives.