About OpenTrainOpenTrain is the #1 platform for finding and building careers in AI training and data labeling. OpenTrain AI recruits experts for specialized projects where qualified judgment helps develop and evaluate advanced AI systems.Creating an OpenTrain account is free, and contributors can build a profile that showcases credible AI training experience while discovering projects aligned with their expertise.Remote contractor opportunityPart-time engagement requiring 20 or more hours per weekCandidates must be based in the United States or CanadaAbout AI Training WorkAI training is the human side of building artificial intelligence. Experts review source material, write high-quality examples, rate model outputs, and create evaluation standards that help AI systems produce more reliable results.In this project, clinical regulatory expertise will help an AI agent handle FDA information request work. Your judgments and examples will contribute to structured evaluation of the agent's regulatory reasoning.Apply specialized professional knowledge to cutting‐edge AI developmentCreate prompts, reference answers, and rubrics for model evaluationWork remotely with flexible contractor hoursThe RoleOpenTrain is seeking a Clinical Regulatory Expert to support AI training workflows involving clinical data rooms, FDA information requests, and regulatory judgment. You will assess whether documents meet FDA evidentiary and formatting expectations, identify deliberately planted defects,



and create high‐quality examples for measuring AI performance.The role combines hands‐on clinical regulatory review with structured evaluation design. Direct FDA review experience is strongly preferred over experience limited to sponsor‐side liaison work.Hourly compensation: $130 to $170 USDRole type: Contractor and part timeWorkload: 20 or more hours per weekWork location: United States or CanadaWhat You'll DoYou will make clear, defensible judgments about clinical regulatory materials and translate expert reasoning into consistent AI evaluation criteria. The work includes both document review and creation of materials used to test an AI agent's performance.Review clinical data rooms and documents against FDA evidentiary standardsAssess documents for FDA formatting expectations and regulatory qualityIdentify deliberate document defects and explain their significanceReview or respond to FDA information requests involving CMCEvaluate requests involving patient‐level data and investigator qualificationsAssess biomarker or endpoint evidence in regulatory materialsAuthor FDA information requests and model responses grounded in regulatory reasoningDesign prompts, golden outputs,



and rubrics for FDA RFI evaluationSupport consistent AI evaluation and clinical data generationRequired QualificationsApplicants must have at least five years of relevant experience. Candidates with 10 to 25 years of relevant experience are preferred. An MD, PhD, PharmD, or equivalent clinical or regulatory credential is required.You must have direct experience reviewing or responding to FDA information requests across CMC, patient‐level data requests, investigator qualifications, and biomarker or endpoint evidence. Candidates must also have no conflict of interest involving a current federal employer.MD, PhD, PharmD, or equivalent clinical or regulatory credentialAt least five years of relevant experienceDirect experience with FDA information requests across the listed subject areasAbility to assess FDA evidentiary and document formatting standardsAbility to identify deliberate regulatory defects and explain their importanceSkill in authoring FDA RFIs and model responsesAbility to create prompts, golden outputs, and evaluation rubricsNo conflict of interest involving a current federal employerPreferred BackgroundExperience authoring regulatory information requests, developing evaluation rubrics, or translating expert judgment into structured AI assessment criteria is especially useful. Direct FDA review experience is preferred to sponsor‐side liaison work alone.Direct FDA review experienceExperience authoring regulatory information requestsExperience developing evaluation rubricsExperience converting expert judgment into structured assessment criteria #J-18808-Ljbffr

📌 Fda Clinical Regulatory Reviewer (Ottawa)
🏢 OpenTrain AI
📍 Ottawa