Medical Writer

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 CEO Surbhi 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 CTO Nate 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 Review AI‑generated regulatory documents produced via Collate for accuracy, format, and regulatory voice/tone Advise on regulatory document lifecycle workflows — how documents actually move through pharma companies in practice, including handoffs, review cycles, and approval chains 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 Advise on submission‑readiness standards to help inform our product requirements and the quality benchmarks we hold our AI‑generated output to 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 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 Early on, your feedback will be translated into product changes by the engineering team. 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 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) 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 — this is a "work alongside engineers" role, not a "hand off a redline" role Genuine curiosity about AI tools and how they can (and can’t yet) support regulatory writing Bonus: existing network or relationships across regulatory affairs, medical writing, or pharma leadership circles Why Join Collate? 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. The base salary range for this role is competitive, depending on experience and level (Tier 1, San Francisco). #J-18808-Ljbffr Collate