Medical Writer
AI Summary
Experienced regulatory medical writer serving as in-house pharma subject matter expert on a consulting basis. Reviews AI-generated regulatory documents for accuracy, format, and regulatory voice, advises on document workflows and submission-readiness, and provides usability feedback to shape product development.
About this role
About Collate
Collate is an AI document generation platform for life sciences. We automate paperwork with AI, helping our customers get life-saving innovations to patients years faster. Collate is an end-to-end solution, powering every step of drug, diagnostic, and medical device development—from concept to market.
Our CEOSurbhi Sarna is a former General Partner at Y Combinator. Surbhi founded nVision Medical, which developed a new method to detect ovarian cancer and was acquired by Boston Scientific. Our CTONate Smith is a former Visiting Partner at Y Combinator and founder of Lever. Our AI researchers, engineers, and designers have worked at Google, Nvidia, Meta, Netflix, Amazon, AirBnB, Hippocratic AI, and Grail, and 40% of our team are former founders.
We’re an elite team, with $125M in funding from top investors (Redpoint, First Round Capital, CRV, Conviction, Y Combinator) and leaders in healthcare and AI. This is a rare chance to join an early-stage company with world-changing potential, experienced founders, and resources to execute at scale.
About the Role
We're looking for an experienced regulatory medical writer to act as our in-house pharma subject matter expert on a consulting basis. You'll work directly with our engineering team to shape how our AI generates, reviews, and formats regulatory documents. This isn't a "review documents in isolation" role — you'll be embedded in tight iteration loops with engineers, giving real-time feedback that directly shapes what we build next.
What You'll Do
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Review AI-generated regulatory documents produced via Collate for accuracy, format, and regulatory voice/tone
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Advise on regulatory document lifecycle workflows — how documents actually move through pharma companies in practice, including handoffs, review cycles, and approval chains
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Provide usability feedback on Collate from the perspective of a working RA professional / medical writer — what feels off, what's missing, what would make you trust and adopt a tool like this
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Advise on submission-readiness standards to help inform our product requirements and the quality benchmarks we hold our AI-generated output to
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Serve as a pharma insider resource — helping us understand org structures, roles, timelines, and internal processes at target pharma companies, and weighing in on industry relationships and positioning (e.g., which pharma leaders and functions we should be building relationships with)
How We'll Work Together
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You'll partner directly with engineers, not just submit written feedback — expect short, iterative cycles where your input shapes a prompt change or feature the same week
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Early on, your feedback will be translated into product changes by the engineering team.
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You'll also be looped in as a pharma SME beyond document review — for example, helping us think through which pharma leaders or functions to prioritize for relationship-building and industry engagement
What We're Looking For
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Experience as a medical writer and/or regulatory affairs professional in pharma or biotech, with hands-on experience preparing or reviewing regulatory submissions (e.g., IND, NDA/BLA, CTD modules, clinical study reports, briefing documents)
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Strong grasp of global regulatory document standards, formatting conventions, and submission-readiness expectations (FDA and/or EMA)
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Familiarity with how regulatory documents move through review, approval, and sign-off inside a pharma organization
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Comfort giving direct, specific feedback in a fast-moving, iterative product environment — this is a "work alongside engineers" role, not a "hand off a redline" role
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Genuine curiosity about AI tools and how they can (and can't yet) support regulatory writing
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Bonus: existing network or relationships across regulatory affairs, medical writing, or pharma leadership circles
