FDA Clinical Regulatory Reviewer

About Open Train

Open Train is the #1 platform for finding and building careers in AI training and data labeling. Open Train 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

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

Open Train 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

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

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

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