Medical Writer

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

IMPORTANT: after you apply, please check your email. We send you a link to complete your application — it is not considered until that last step is done. If you do not see it, check your spam folder.

This is a fully remote position, open to candidates based in Canada.

Pay: $30–$60/hr

Role Title: Medical Writer (Pharmaceutical)

Role Type: Contractor

Location: Remote

We are engaging Medical Writers / Clinical Document Authors to participate in a customer’s project focused on developing advanced AI-assisted writing tools for clinical documentation. In this role, you'll apply your expertise to help train next-generation AI systems. Your work will shape how models learn, reason, and perform through high-quality, real-world input. No prior experience in AI is required — your domain knowledge is what matters.

Scope of Work

1. Author and review realistic evaluation tasks based on Clinical Study Reports, DSURs, PSURs/PBRERs, and related clinical documents to inform AI tool development.
2. Apply expert judgment to assess whether AI-generated content fulfills clinical template and structural requirements, including ICH E3 organization, section sequencing, cross-referencing, and appendix management.
3. Evaluate scientific accuracy in narrative sections such as efficacy, safety summaries, discussion, and conclusions, distinguishing true scientific or interpretive errors from stylistic differences.
4. Trace narrative claims to source records—tables, figures, listings, and protocols—to verify that all assertions are appropriately supported.
5. Provide clear and structured written rationales for each assessment, enabling precise diagnosis and improvement of AI model behavior.
6. Collaborate with project leads to refine evaluation frameworks and document best practices for clinical regulatory writing in the context of AI.

Preferred Qualifications

1. Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant.
2. Direct experience independently authoring or leading the authoring of full Clinical Study Reports, beyond summaries or partial contributions.
3. Fluency with ICH E3 and conventions for periodic safety documentation (ICH E2F, ICH E2C) and eCTD placement.
4. Demonstrated ability to read and interpret TFLs and protocol documents, identifying where narrative diverges from source data.
5. Exceptional written and verbal communication skills, especially in providing structured, actionable feedback on clinical content.
6. Advanced degree in life sciences, pharmacy, or medicine (PhD, PharmD, MD, MSc), or equivalent depth of authoring experience.
7. Experience across multiple clinical phases and therapeutic areas; oncology and haematology expertise is especially valued.

Join our customer's team and leverage your authoring expertise to help design the next generation of AI-assisted clinical documentation solutions. This high-bar role offers you the chance to shape how tomorrow's writing teams draft and review regulatory documents — through your expert input, judgment, and real-world experience.