Medical Writer for AI-Assisted Clinical Documentation

Apply regulatory medical writing expertise to author and evaluate clinical documentation that trains and validates AI-assisted clinical writing tools. This role focuses on ensuring scientific accuracy, regulatory structure, and traceability to source data for documents used in regulatory submissions and safety reporting.

• Author and review realistic evaluation tasks derived from Clinical Study Reports, Development Safety Update Reports (DSURs), Periodic Safety Update Reports or PBRERs, and related clinical documents.
• Assess AI-generated content for compliance with clinical templates and structure, including ICH E3 organization, section sequencing, cross-referencing, and appendix management.
• Evaluate scientific accuracy in narrative sections, for example efficacy summaries, safety summaries, discussion, and conclusions, distinguishing true scientific or interpretive errors from stylistic variation.
• Trace narrative claims back to source records, such as tables, figures, listings (TFL), and protocols, to verify that assertions are supported by the data.
• Provide clear, structured written rationales for each assessment to enable precise diagnosis and improvement of AI model behavior.
• Collaborate with project leads to refine evaluation frameworks and document best practices for regulatory clinical writing in an AI development context.
• Review AI-assisted documentation outputs and provide targeted feedback for model training and evaluation, including periodic safety documentation and eCTD placement considerations.

• 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 knowledge of eCTD placement.
• Demonstrated ability to read and interpret TFLs, tables, figures, listings, and clinical protocols, and to identify when narrative content diverges from source data.
• Exceptional written and verbal communication skills, with an emphasis on providing structured, actionable feedback on clinical content.
• Advanced degree in life sciences, pharmacy, or medicine (PhD, PharmD, MD, MSc), or equivalent depth of authoring experience.
• Experience across multiple clinical phases and therapeutic areas, with oncology and haematology domain expertise especially valued.
• No prior AI experience is required, subject matter expertise in regulatory writing is the priority.

• Engagement type, contractor, remote work.
• Work is performed on a customer project centered on developing advanced AI-assisted clinical documentation tools.
• Independent contractor status, paid on an hourly basis.

• Pay range: 50 to 80 USD per hour.

• Must have the minimum of 5 years regulatory medical writing experience as stated above.
• Candidates must be able to serve as independent contractors for remote engagements and meet any relevant local regulatory or tax obligations for contract work.