Senior Medical Writer: CSR & Regulatory - Remote

YO AI Labs; San Francisco (CA); Remote; USD 69.000 - 110.000; Vollzeit

Zusammenfassung

YO AI Labs seeks an experienced Medical Writer Expert for remote contract work. You will develop, review, and evaluate clinical and regulatory documents with a focus on accuracy, regulatory compliance, and quality.

This role requires deep expertise in CSRs, ICH guidelines, and eCTD knowledge, with collaboration across cross-functional teams. The ideal candidate has 5+ years in regulatory medical writing, oncology/haematology exposure preferred, and strong written communication skills to support

Qualifikationen

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

Aufgaben

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

Kenntnisse

Regulatory Medical Writing

CSR Authoring

ICH E3 Guidelines

Scientific Accuracy Assessment

Source Data Verification

Clinical Protocol Interpretation

TFL Analysis

eCTD Knowledge

Written Communication

Ausbildung

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

Jobbeschreibung

YO AI Labs seeks an experienced Medical Writer Expert for remote contract work. You will develop, review, and evaluate clinical and regulatory documents with a focus on accuracy, regulatory compliance, and quality.

This role requires deep expertise in CSRs, ICH guidelines, and eCTD knowledge, with collaboration across cross-functional teams. The ideal candidate has 5+ years in regulatory medical writing, oncology/haematology exposure preferred, and strong written communication skills to support