Medical Writer for AI-Assisted Clinical Documentation

Apply regulatory medical writing expertise to author and evaluate clinical documentation used to train and assess AI-assisted writing tools. In this contractor role you will create and review realistic evaluation tasks based on clinical study documents, verify scientific accuracy against source records, and provide structured rationales that guide model improvement. No prior AI experience is required, your clinical regulatory writing experience is the focus.

• Author and review evaluation tasks derived from Clinical Study Reports, Development Safety Update Reports, PSURs/PBRERs, and related regulatory 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 narrative sections such as efficacy, safety summaries, discussion, and conclusions, distinguishing interpretive or data errors from stylistic differences.
• Trace narrative claims back to source records, including tables, figures, listings, and protocols, to verify that assertions are supported by the underlying data.
• Provide clear, structured written rationales and feedback for each assessment to enable targeted improvements in model behavior.
• Collaborate with project leads to refine evaluation frameworks and capture best practices for regulatory clinical writing in the context of AI-assisted documentation.

• Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant.
• Direct experience independently authoring or leading the authoring of full Clinical Study Reports, not only summaries or partial contributions.
• Fluency with ICH E3 and conventions for periodic safety documentation, including ICH E2F and ICH E2C, and familiarity with eCTD placement.
• Demonstrated ability to read and interpret TFLs, tables, figures, listings, and protocol documents, and to identify where narrative content diverges from source data.
• Exceptional written and verbal communication skills, with experience providing structured, actionable feedback on clinical content.
• Advanced degree in a relevant life science field such as PhD, PharmD, MD, or MSc, or equivalent depth of authoring experience.
• Experience across multiple clinical phases and therapeutic areas; domain expertise in oncology and haematology is especially valued.

• Engagement type: Contractor.
• Location: Remote.
• Project focus: Contributing to a client project developing AI-assisted clinical documentation and evaluation tools.
• No prior AI or machine learning experience required.

• Rate: $50.00 to $80.00 per hour.

• Candidates must be able to work as independent contractors. Specific work-authorization or sponsorship conditions were not provided; applicants should be able to accept contractor payment under their own legal and tax arrangements.