Medical Writer / Clinical Document Author

micro1 is seeking experienced Medical Writers and Clinical Document Authors to contribute to a project focused on developing advanced AI-assisted tools for clinical documentation. In this role, you will leverage your deep domain expertise to train next-generation AI systems, ensuring that models learn to reason and perform with the high standards required in clinical regulatory writing.

Key responsibilities

• Author and review realistic evaluation tasks based on Clinical Study Reports, DSURs, and PSURs to inform AI tool development.
• Apply expert judgment to assess whether AI-generated content meets clinical template and structural requirements, including ICH E3 organization.
• Evaluate scientific accuracy in safety summaries and efficacy narratives, distinguishing between interpretive errors and stylistic choices.
• Trace narrative claims back to source records, such as tables, figures, and protocols, to verify that all assertions are supported by data.
• Provide clear, structured written rationales for assessments to enable precise improvements in AI model behavior.

Requirements

• Minimum of 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant.
• Direct experience independently authoring full Clinical Study Reports.
• Fluency with ICH E3 guidelines and conventions for periodic safety documentation.
• Demonstrated ability to interpret TFLs and protocol documents to identify data discrepancies.
• Advanced degree in life sciences, pharmacy, or medicine, or equivalent depth of professional authoring experience.

What we offer

• The opportunity to shape the future of AI-assisted clinical documentation through your expert input.
• A high-impact role where your professional judgment directly influences the development of next-generation writing tools.
• Collaboration with project leads to refine evaluation frameworks and establish best practices for regulatory writing.