Medical Writer

Collate • San Francisco, CA

6d • Remote

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 the AI's generation, review, and formatting of regulatory documents. The position is characterized by tight iteration loops with engineers, providing real-time feedback that directly shapes product development. It is not a standalone document review position.

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.
• Experience working alongside engineers, not just submitting redlines.
• 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.

Responsibilities

• Review AI-generated regulatory documents produced via Collate for accuracy, format, and regulatory voice/tone.
• Advise on regulatory document lifecycle workflows, including how documents move through pharma companies in practice, handoffs, review cycles, and approval chains.
• Provide usability feedback on Collate from the perspective of a working RA professional / medical writer.
• Advise on submission-readiness standards to inform product requirements and quality benchmarks for AI-generated output.
• Serve as a pharma insider resource to help understand org structures, roles, timelines, and internal processes at target pharma companies.
• Weigh in on industry relationships and positioning, including which pharma leaders and functions to build relationships with.

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.
• Competitive base salary range, depending on experience and level (Tier 1, San Francisco).

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed