CMC Technical Writing Consultant
About The Position
Edison Scientific builds and commercializes AI agents for science. Scientific discovery moves too slowly, and autonomous AI agents are how we intend to fix that. We're assembling a team of top researchers and engineers across AI and biology to build an AI scientist. We are seeking an experienced CMC Technical Writing Consultant for a flexible, part-time engagement. You'll serve as the subject matter expert who defines the gold standard for AI-generated CMC documentation — ensuring our platform produces outputs that are technically accurate, submission-ready, and aligned with current regulatory expectations. This is an opportunity to directly influence how CMC content gets written, reviewed, and refined at scale. Your expertise will help shape the quality bar our tools are held to, from drug substance and drug product descriptions to manufacturing process narratives and quality control summaries. This engagement is designed to fit around existing commitments, at approximately 5–20 hours per week. We engage with domain experts to help design and build these tasks, and help us know what we don’t know. Day to day that might look like any or all of the following sorts of activities (and more): Knowledge sharing about "day-in-the-life" as an expert working with data in these domains to assemble regulatory submissions. Describing common tasks or problems where AI could be of value in your workflows. Identify + describe internal pharma systems that are commonly used for standard workflows. Generate or review reference ground-truth artifacts to evaluate against - reports, data files, modules, etc. Identify + add realistic sources of variance or data corruption in study data. Identify and correct discrepancies in data quality.
Requirements
- 10+ years of experience in CMC regulatory writing within the pharmaceutical/biotechnology industry, ideally with a sponsor.
- Bachelor's Degree required.
- Hands-on experience authoring Module 3 documents, including drug substance and drug product sections for IND submissions.
- Strong understanding of CMC regulatory requirements.
- Familiarity with ICH guidelines and FDA/EMA expectations.
- Experience supporting regulatory submissions across early-phase INDs.
Nice To Haves
- Advanced degree preferred.
Responsibilities
- Serve as the subject matter expert who defines the gold standard for AI-generated CMC documentation.
- Ensure the platform produces CMC outputs that are technically accurate, submission-ready, and aligned with current regulatory expectations.
- Influence how CMC content gets written, reviewed, and refined at scale.
- Shape the quality bar for tools related to drug substance and drug product descriptions, manufacturing process narratives, and quality control summaries.
- Share knowledge about the "day-in-the-life" of an expert working with data to assemble regulatory submissions.
- Describe common tasks or problems where AI could be of value in workflows.
- Identify and describe internal pharma systems used for standard workflows.
- Generate or review reference ground-truth artifacts for evaluation.
- Identify and add realistic sources of variance or data corruption in study data.
- Identify and correct discrepancies in data quality.
Benefits
- Competitive salary and equity
- Full healthcare coverage — we pay 100% of premiums for you and your dependents
- Support for growing families, including a yearly new parent stipend and fertility coverage through Carrot
- 401(k) company matching
- $300 health and wellness benefit
- Lunch is on us every day you're in the office, and dinner is on us when you're working late
- Regular team offsites and company events
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What This Job Offers
Job Type
Part-time
Career Level
Senior
