About OpenTrain

OpenTrain is the #1 platform for finding and building careers in AI training and data labeling. OpenTrain AI recruits experts for specialized projects where professional judgment helps develop and evaluate advanced AI systems.

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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 explicit, 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

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