Clinical Regulatory Document AI Evaluation Writer

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About AI Training Work

AI training is the human side of building artificial intelligence. Specialists review model outputs, create high-quality examples, and provide structured feedback so AI systems can become more accurate, reliable, and useful.

This role applies that process to clinical regulatory documentation, where expert judgment is essential for evaluating scientific interpretation, document organization, and support for clinical claims.

The Role

OpenTrain is seeking a Clinical Regulatory Document AI Evaluation Writer to support the development of AI-assisted clinical documentation tools. You will author and review evaluation tasks, assess AI-generated clinical content, and provide precise feedback on structure, scientific accuracy, and evidentiary support.

This is a worldwide, remote contractor opportunity conducted in English. The role is part time and requires 20 or more hours per week.

• Employment type: Contractor and part time
• Advertised compensation: $50-$80 per hour
• Work location: Worldwide and remote
• Working language: English

What You'll Do

You will use hands-on regulatory medical writing experience to create realistic evaluation material and judge whether AI-generated clinical narratives meet professional and scientific standards.

• Author evaluation tasks based on Clinical Study Reports, DSURs, PSURs/PBRERs, and related clinical documents.
• Review AI-generated narratives for ICH E3 organization, section sequencing, cross-referencing, and appendix management.
• Evaluate efficacy, safety, discussion, and conclusion sections for scientific and interpretive accuracy.
• Trace narrative claims to tables, figures, listings, protocols, and other source records.
• Distinguish substantive scientific errors from stylistic variation.
• Document clear, structured rationales for each assessment.
• Help refine evaluation frameworks and best practices for clinical regulatory writing in AI systems.

Required Experience And Skills

This work requires substantial regulatory authoring experience and the ability to make independent judgments about clinical evidence and document quality. Prior AI experience is not required; the role depends on rigorous clinical judgment and regulatory writing knowledge.

• At least five years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant.
• Direct experience independently authoring or leading full Clinical Study Reports from end to end, rather than only summaries or individual sections.
• Fluency with ICH E3 and periodic safety documentation conventions, including ICH E2F and ICH E2C.
• Knowledge of eCTD placement and regulatory writing conventions.
• Ability to interpret TFLs and protocols and identify where narratives diverge from source data.
• Ability to evaluate efficacy, safety, discussion, and conclusion narratives for scientific accuracy.
• Strong written and verbal communication skills, especially for structured and actionable clinical feedback.

Helpful Background

An advanced degree in life sciences, pharmacy, or medicine—such as a PhD, PharmD, MD, or MSc—is valued, as is equivalent depth of regulatory authoring experience. Experience across multiple clinical phases and therapeutic areas is useful, with oncology and haematology expertise especially relevant.

• Advanced life-sciences, pharmacy, or medical training, or equivalent regulatory authoring depth.
• Experience across multiple clinical phases.
• Experience across multiple therapeutic areas.
• Oncology or haematology expertise.
• Prior AI experience is not required.

Why Work In AI Training

AI training offers flexible, remote work that lets specialists contribute directly to cutting-edge technology. Your clinical regulatory expertise can help determine whether AI systems produce content that is scientifically sound, appropriately supported, and fit for professional use.

Many AI-training projects are designed for part-time participation, making it possible to fit meaningful technical work around other professional commitments.

Build Your AI Training Career With OpenTrain

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