Remote Medical Writer for AI-Driven Clinical Docs

RemoteJobsOne; Toronto; Remote; CAD 41,000 - 83,000; Part time

Job summary

RemoteJobsOne in Canada seeks a Medical Writer (Pharmaceutical) to join a fully remote contractor team developing AI-assisted clinical documentation. You will apply regulatory expertise to review and author safety and efficacy sections, ensure ICH E3 alignment, and support model training with real-world inputs.

The role emphasizes high-quality, structured rationales, traceability to source documents, and collaboration with project leads to refine evaluation frameworks for AI-enabled regulatory

Qualifications

• Minimum 5 years of regulatory medical writing experience in pharma or CRO settings.
• Experience authoring or leading full Clinical Study Reports, beyond summaries.
• Strong understanding of ICH E3, E2F/C and eCTD placement.

Responsibilities

• Author and review regulatory medical writing deliverables for clinical documentation.
• Assess AI-generated content for compliance with clinical template and ICH structure.
• Verify narrative accuracy against source records such as CSRs and PSURs.
• Provide structured, written rationales for assessments to guide model improvements.
• Collaborate with project leads to refine evaluation frameworks for AI tools.
• Document best practices for regulatory writing in AI-enabled contexts.

Skills

Regulatory writing

Clinical documentation

ICH E3 familiarity

Education

Advanced degree in life sciences

Tools

eCTD knowledge

Job description

RemoteJobsOne in Canada seeks a Medical Writer (Pharmaceutical) to join a fully remote contractor team developing AI-assisted clinical documentation. You will apply regulatory expertise to review and author safety and efficacy sections, ensure ICH E3 alignment, and support model training with real-world inputs.

The role emphasizes high-quality, structured rationales, traceability to source documents, and collaboration with project leads to refine evaluation frameworks for AI-enabled regulatory