Senior Medical Writer - Regulatory CSR Expert (Remote)

YO AI Labs; Austin (TX); Remote; USD 69,000 - 110,000; Part time

Job summary

YO AI Labs seeks 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. This remote contractor role offers an hourly pay rate of $50–$80.

Responsibilities include authoring and reviewing CSRs, interpreting protocols per ICH guidelines, verifying accuracy against source data and TFLs, and contributing to AI-assisted documentation quality

Qualifications

• Regulatory medical writing experience (5+ years) in sponsor/CRO/consulting.
• Experience authoring Clinical Study Reports and regulatory documentation.
• Strong knowledge of ICH E3, E2F, E2C and eCTD requirements.
• Advanced degree in Life Sciences, Pharmacy, Medicine, or related field.
• Experience in oncology and haematology preferred.

Responsibilities

• Author and review Clinical Study Reports (CSRs) and regulatory documents.
• Interpret clinical protocols and ensure ICH guideline compliance.
• Verify scientific accuracy using source data, TFLs, and study documents.
• Review safety documentation including DSURs and PSURs/PBRERs.
• Provide structured feedback and collaborate with cross-functional teams.
• Support AI-assisted documentation evaluation and quality 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

Education

Advanced degree in Life Sciences/Pharmacy/Medicine

Job description

YO AI Labs seeks 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. This remote contractor role offers an hourly pay rate of $50–$80.

Responsibilities include authoring and reviewing CSRs, interpreting protocols per ICH guidelines, verifying accuracy against source data and TFLs, and contributing to AI-assisted documentation quality