Remote Medical Writer: CSR & Regulatory Docs Expert

YO AI Labs; Los Angeles (CA); À distance; USD 69 000 - 110 000; Temps partiel

Résumé du poste

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.

You will author and review CSRs and other regulatory documents, interpret clinical protocols per ICH guidelines, verify data using source data listings, and contribute to DSURs/PSURs.

Qualifications

• 5+ years of regulatory medical writing experience.
• 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 related field.
• Experience in oncology and haematology preferred.

Responsabilités

• 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.

Connaissances

Regulatory Medical Writing

CSR Authoring

ICH E3 Guidelines

Scientific Accuracy Assessment

Source Data Verification

Clinical Protocol Interpretation

TFL Analysis

eCTD Knowledge

Written Communication

Formation

Advanced degree in Life Sciences/Pharmacy/Medicine

Outils

eCTD platforms

Description du poste

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.

You will author and review CSRs and other regulatory documents, interpret clinical protocols per ICH guidelines, verify data using source data listings, and contribute to DSURs/PSURs.