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About the Role
We are seeking an experienced regulatory medical writer to serve as our in-house pharma subject matter expert on a consulting basis. You will collaborate directly with our engineering team to influence the AI's generation, review, and formatting of regulatory documents. This role involves embedded, iterative feedback loops with engineers, directly shaping upcoming product development.
Responsibilities
- Review AI-generated regulatory documents for accuracy, format, and regulatory voice/tone.
- Advise on regulatory document lifecycle workflows within pharma companies.
- Provide usability feedback on the platform from a regulatory affairs professional's perspective.
- Advise on submission-readiness standards to inform product requirements and AI output quality benchmarks.
- Serve as a pharma insider resource, providing insights on organizational structures, roles, timelines, and internal processes.
- Assist in understanding industry relationships and positioning, including identifying key pharma leaders and functions for engagement.
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 understanding of global regulatory document standards, formatting conventions, and submission-readiness expectations (FDA and/or EMA).
- Familiarity with regulatory document review, approval, and sign-off processes within pharma organizations.
- Comfort providing direct, specific feedback in a fast-moving, iterative product environment.
- Genuine curiosity about AI tools and their application in regulatory writing.
Skills
- Regulatory document review
- Regulatory affairs
- Medical writing
- AI tools
- Pharma industry knowledge
- Communication
- Feedback provision
Location
- San Francisco
Work Type
- Consulting
- Onsite
Experience Level
- Experienced
- Tier 1
Salary/Compensations
- Competitive, depending on experience and level
Benefits
- Meaningful equity
- Career-defining impact
About the Company
- Collate is an AI document generation platform for life sciences, automating paperwork to accelerate the delivery of life-saving innovations.
- The company's leadership includes experienced founders with backgrounds from Y Combinator, Google, Nvidia, Meta, Netflix, Amazon, AirBnB, and more.
- Collate has secured $125M in funding from prominent investors like Redpoint, First Round Capital, CRV, Conviction, and Y Combinator.
- This is an early-stage opportunity with world-changing potential, experienced founders, and resources for large-scale execution.