Medical Writer
TLDR
Shape AI-generated regulatory documents with engineers in tight, iterative cycles to produce submission-ready output.
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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)
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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
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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
Why Join Collate?
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Impact: Build systems and experiences that touch real patients and providers, improving healthcare outcomes.
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Ownership: Shape both our product experience and our engineering culture from the start.
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Learning: Collaborate with a uniquely interdisciplinary team—AI researchers, healthcare leaders, and experienced startup builders.
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Upside: Join a company early enough to have meaningful equity and career-defining impact.
Benefits
Equity Compensation
meaningful equity
Collate is an AI document generation platform tailored for the life sciences sector, designed to streamline the paperwork process and accelerate the delivery of life-saving innovations to patients. Our comprehensive solution supports every stage of drug, diagnostic, and medical device development, from concept to market.