Medical Writer (Pharmaceutical)

Key details

• Author and review realistic evaluation tasks based on Clinical Study Reports, DSURs, PSURs/PBRERs, and related clinical documents to inform AI tool development
• Apply expert judgment to assess whether AI-generated content fulfills 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 true scientific or interpretive errors from stylistic differences
• Trace narrative claims to source records—tables, figures, listings, and protocols—to verify that all assertions are appropriately supported
• Provide clear and structured written rationales for each assessment, enabling precise diagnosis and improvement of AI model behavior
• Collaborate with project leads to refine evaluation frameworks and document best practices for clinical regulatory writing in the context of AI
• Company mission
• micro1 is engaging Medical Writers / Clinical Document Authors to participate in a customer's project focused on developing advanced AI-assisted writing tools for clinical documentation