Clinical Documentation Specialist | $80/hr Remote

Contract role, 10–40 hrs/week, fully remote, $50–$80/hour.

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

• Strong relevant experience in regulatory medical writing at a sponsor, CRO, or as an independent consultant.
• Direct experience 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; oncology and haematology expertise valued.