09 Aug
|
Crossing Hurdles
|
Canada
09 Aug
Crossing Hurdles
Canada
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 robust 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.
Application Process
- Easy Apply on LinkedIn
- Check email for next steps
- Participate in resume evaluation & interview stage
📌 Clinical Documentation Specialist | $80/hr Remote (Canada)
🏢 Crossing Hurdles
📍 Canada