05 Sep
|
Crossing Hurdles
|
Manitoba
05 Sep
Crossing Hurdles
Manitoba
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.
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📌 Medical Writer | $80/hr Remote (Manitoba)
🏢 Crossing Hurdles
📍 Manitoba