Remote Medical Writer: CSR & Regulatory Author

YO AI Labs; Miami (FL); Remote; USD 69,000 - 110,000; Part time

Job summary

YO AI Labs is seeking an experienced Medical Writer / Clinical Document Author to develop and review regulatory documents with a focus on scientific accuracy and compliance. The role emphasizes CSR creation, protocol interpretation, and collaboration across cross-functional teams.

The ideal candidate will have 5+ years in regulatory medical writing, expertise in ICH guidelines, and experience with eCTD. This contractor position offers remote work and competitive hourly pay.

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 related field (MD, PharmD, PhD, 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

ICH E2F knowledge

ICH E2C knowledge

eCTD knowledge

Source data verification

Clinical protocol interpretation

TFL analysis

Strong written communication

Education

Advanced degree in Life Sciences/Pharmacy/Medicine

Job description

YO AI Labs is seeking an experienced Medical Writer / Clinical Document Author to develop and review regulatory documents with a focus on scientific accuracy and compliance. The role emphasizes CSR creation, protocol interpretation, and collaboration across cross-functional teams.

The ideal candidate will have 5+ years in regulatory medical writing, expertise in ICH guidelines, and experience with eCTD. This contractor position offers remote work and competitive hourly pay.