Job Description

Apply your clinical regulatory writing expertise to help evaluate and improve AI-assisted tools for clinical documentation. This remote contract role centers on authoring realistic evaluation tasks, reviewing AI-generated clinical content, and providing expert feedback grounded in source data and regulatory standards. No prior AI experience is required. Key Responsibilities

• Author and review realistic evaluation tasks based on Clinical Study Reports, DSURs, PSURs/PBRERs, and related clinical documents.
• Assess whether AI-generated content meets clinical template and structural requirements, including ICH E3 organization, section sequencing, cross-referencing, and appendix management.
• Evaluate scientific accuracy in efficacy, safety, discussion, conclusion, and other narrative sections, separating scientific or interpretive errors from stylistic differences.
• Trace narrative claims to source records, including tables, figures, listings, and protocols, to confirm that assertions are supported.
• Provide clear, structured written rationales that help identify and improve AI model behavior.
• Collaborate with project leads to refine evaluation frameworks and document clinical regulatory writing best practices for AI-assisted documentation.

• At least 5 years of regulatory medical writing experience with a sponsor, CRO, or as an independent consultant.
• Experience independently authoring or leading the authoring of complete Clinical Study Reports, beyond summaries or partial contributions.
• Fluency with ICH E3, periodic safety documentation conventions including ICH E2F and ICH E2C, and eCTD placement.
• Ability to interpret TFLs, tables, figures, listings, and clinical protocols, including identifying where narrative content diverges from source data.
• Strong written and verbal communication skills, particularly for delivering structured, actionable feedback on clinical content.
• An advanced degree in life sciences, pharmacy, or medicine, such as a PhD, PharmD, MD, or MSc, or equivalent depth of authoring experience.
• Experience across multiple clinical phases and therapeutic areas. Oncology and haematology expertise is especially valued.

• Remote contract engagement.

• $30 to $60 per hour.

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