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Remote contractor opportunity
Part-time engagement requiring 20 or more hours per week
Candidates must be based in the United States or Canada
About AI Training Work AI 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 development
Create prompts, reference answers, and rubrics for model evaluation
Work remotely with flexible contractor hours
The Role OpenTrain 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 USD
Role type: Contractor and part time
Workload: 20 or more hours per week
Work location: United States or Canada
What You'll Do You 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 standards
Assess documents for FDA formatting expectations and regulatory quality
Identify deliberate document defects and explain their significance
Review or respond to FDA information requests involving CMC
Evaluate requests involving patient‑level data and investigator qualifications
Assess biomarker or endpoint evidence in regulatory materials
Author FDA information requests and model responses grounded in regulatory reasoning
Design prompts, golden outputs, and rubrics for FDA RFI evaluation
Support consistent AI evaluation and clinical data generation




Required Qualifications Applicants 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 credential
At least five years of relevant experience
Direct experience with FDA information requests across the listed subject areas
Ability to assess FDA evidentiary and document formatting standards
Ability to identify deliberate regulatory defects and explain their importance
Skill in authoring FDA RFIs and model responses
Ability to create prompts, golden outputs, and evaluation rubrics
No conflict of interest involving a current federal employer
Preferred Background Experience 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 experience
Experience authoring regulatory information requests
Experience developing evaluation rubrics
Experience converting expert judgment into structured assessment criteria

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📌 FDA Clinical Regulatory Reviewer (Manitoba)
🏢 OpenTrain AI
📍 Manitoba