About the position
Collate is seeking an experienced regulatory medical writer to serve as an in-house pharma subject matter expert on a consulting basis. This role involves close collaboration with the engineering team to influence how AI generates, reviews, and formats regulatory documents. The position is highly integrated, requiring real-time feedback that directly shapes product development, rather than a traditional isolated document review function.
Responsibilities
• Review AI-generated regulatory documents produced via Collate for accuracy, format, and regulatory voice/tone.
• Advise on regulatory document lifecycle workflows, including document movement through pharma companies, handoffs, review cycles, and approval chains.
• Provide usability feedback on Collate from the perspective of a working RA professional/medical writer, identifying areas for improvement and trust-building.
• Advise on submission-readiness standards to inform product requirements and quality benchmarks for AI-generated output.
• Serve as a pharma insider resource, providing insights into organizational structures, roles, timelines, and internal processes at target pharma companies, and advising on industry relationships and positioning.
Requirements
• Experience as a medical writer and/or regulatory affairs professional in pharma or biotech.
• Hands-on experience preparing or reviewing regulatory submissions (e.g., IND, NDA/BLA, CTD modules, clinical study reports, briefing documents).
• Strong grasp of global regulatory document standards, formatting conventions, and submission-readiness expectations (FDA and/or EMA).
• Familiarity with how regulatory documents move through review, approval, and sign-off inside a pharma organization.
• Comfort giving direct, specific feedback in a fast-moving, iterative product environment.
• Genuine curiosity about AI tools and their potential to support regulatory writing.
Nice-to-haves
• Existing network or relationships across regulatory affairs, medical writing, or pharma leadership circles.
Benefits
• Impact: Build systems and experiences that touch real patients and providers, improving healthcare outcomes.
• Ownership: Shape both our product experience and our engineering culture from the start.
• Learning: Collaborate with a uniquely interdisciplinary team—AI researchers, healthcare leaders, and experienced startup builders.
• Upside: Join a company early enough to have meaningful equity and career-defining impact.