CMC Technical Writing Consultant
About reputed company 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. The Opportunity We are seeking an reputed company 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-reputed company, and reputed company with reputed company 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 reputed company don’t know. Day to day that might look like any or reputed company 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. Qualifications 10+ years of experience in CMC regulatory writing reputed company the pharmaceutical/biotechnology industry, ideally with a sponsor. Bachelor's Degree required; Advanced degree preferred. Hands-on experience authoring Module 3 documents, including drug substance and drug product sections for IND submissions. Strong understanding of CMC regulatory requirements and familiarity with ICH guidelines and FDA/EMA expectations. Experience supporting regulatory submissions across early-phase INDs. Why join us? Remote/US based reputed company / flexible time zone - 5-20 hours per week Note: For consulting opportunities, we do not offer benefits. Why join us? Competitive salary and equity Full reputed company 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 reputed company 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 reputed company you're working late Regular team offsites and company events A fast-moving, mission-driven culture where smart people do their best work and actually enjoy doing it reputed company is an equal opportunity employer. We do not discriminate on the basis of race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, age, disability, veteran status, or any other protected characteristic under applicable law. Apply To This Job