Medical Writer | $80/hr Remote

Crossing Hurdles; Canada; On-site; CAD 69,000 - 110,000; Part time

Job summary

Crossing Hurdles is seeking a Medical Writer / Clinical Document Author on a contract basis to support AI tool development. This remote role requires strong regulatory medical writing experience and the ability to author or lead full Clinical Study Reports.

You will review evaluation tasks, ensure clinical template compliance, and provide structured rationales to improve AI model behavior, collaborating with project leads across multiple therapeutic areas including oncology and haematology.

Qualifications

• Experience in regulatory medical writing for Clinical Study Reports (CSRs).
• Ability to interpret TFLs and protocol documents for narrative alignment.
• Familiarity with ICH E3 and eCTD placement standards.
• Proven ability to provide structured, actionable feedback on medical narratives.

Responsibilities

• Author and review evaluation tasks based on CSRs and related documents for AI tool development.
• Assess AI-generated content for compliance with clinical templates and structural requirements.
• Evaluate scientific accuracy in narrative sections and identify true errors vs. stylistic differences.
• Verify narrative claims against source records to ensure appropriate support.
• Provide structured written rationales to improve AI model behavior.
• Collaborate with project leads to refine evaluation frameworks and document best practices.

Skills

Regulatory writing

CSR authoring

ICH E3

TFL interpretation

Science communication

Education

Advanced degree in life sciences, pharmacy, or medicine

Job description

Position: Medical Writer / Clinical Document Author Type: Contract Compensation: $50 - $80/hour Location: Remote Commitment: 10-40 hrs/week

Role Responsibilities

• Author and review evaluation tasks based on Clinical Study Reports and related documents for AI tool development.
• Assess AI-generated content for compliance with clinical template and structural requirements.
• Evaluate scientific accuracy in narrative sections, identifying true errors versus stylistic differences.
• Verify narrative claims against source records to ensure appropriate support.
• Provide structured written rationales for assessments to improve AI model behavior.
• Collaborate with project leads to refine evaluation frameworks and document best practices.

Requirements

• Have strong relevant experience in regulatory medical writing at a sponsor, CRO, or as an independent consultant.
• Direct experience in authoring or leading the authoring of full Clinical Study Reports.
• Fluency with ICH E3 and conventions for periodic safety documentation and eCTD placement.
• Demonstrated ability to interpret TFLs and protocol documents, identifying narrative divergences.
• Exceptional written and verbal communication skills for providing structured feedback.
• Advanced degree in life sciences, pharmacy, or medicine, or equivalent authoring experience.
• Experience across multiple clinical phases and therapeutic areas, with oncology and haematology expertise valued.