Principal Medical Writing Domain Expert

What you'll do

• Guide product and engineering teams to design an AI-enabled medical writing platform.
• Define document generation frameworks for mapping clinical data into regulatory-grade documents.
• Establish quality criteria, review protocols, and verification frameworks for automated outputs.
• Refine internal instructions and content logic used by the system to generate complex narratives.
• Participate in the sales cycle by demonstrating expertise to prospective buyers.
• Advise early adopter companies on transitioning from manual drafting to human-in-the-loop processes.

What we're looking for

• Must have 7+ years of medical writing experience in pharma, biotech, or CROs.
• Must have extensive experience authoring complex regulatory documents.
• Must possess a deep operational understanding of global regulatory guidelines such as ICH E3.
• Must demonstrate expertise in complex clinical data mapping.
• Must possess exceptional communication, presentation, and relationship-management skills for commercial cycles.
• Must have an adaptive mindset regarding how generative AI can transform regulatory document workflows.
• Prior experience collaborating with software vendors or innovation teams to develop medical writing technology (preferred).