Clinical Regulatory Document AI Evaluation Writer

About OpenTrain

OpenTrain is the #1 platform for finding and building careers in AI training and data labeling. OpenTrain AI is recruiting contractors for specialized projects where experienced professionals help shape how advanced AI systems work.

• Build a credible AI training portfolio through specialized work
• Discover projects that match your professional expertise
• Apply through OpenTrain and manage your AI training career in one place

About AI Training Work

AI training is the human side of building artificial intelligence. Experts review model outputs, create evaluation examples, and provide precise feedback so AI systems can produce more accurate, reliable, and useful results.

• Work remotely with a computer and internet connection
• Use your clinical regulatory expertise in a growing technology field
• Help improve AI-assisted documentation through expert human judgment

The Role

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

This contractor role is part-time and requires 20+ hours per week. The advertised rate is $50-$80 per hour. Work is available worldwide, and English fluency is required.

• Employment type: Contractor, part-time
• Time requirement: 20+ hours per week
• Location: Worldwide, remote
• Language: English
• Pay: $50-$80 per hour

What You'll Do

You will apply real-world regulatory medical writing experience to structured AI evaluation work. Your assessments should distinguish meaningful scientific or regulatory errors from acceptable stylistic differences and explain the reasoning behind each rating.

• Author realistic 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
• Document clear rationales for each assessment
• Help refine evaluation frameworks and best practices for clinical regulatory writing in AI systems

Requirements

You must have at least five years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant. Direct experience independently authoring or leading complete Clinical Study Reports from end to end is required; experience limited to summaries or individual sections is not sufficient.

You should understand ICH E3 and periodic safety documentation conventions, including ICH E2F and ICH E2C, as well as regulatory writing and eCTD placement requirements. You must be able to interpret TFLs and protocols and identify where narratives diverge from source data.

• At least five years of regulatory medical writing experience
• End-to-end authorship or leadership of full Clinical Study Reports
• Knowledge of ICH E3, ICH E2F, ICH E2C, and eCTD placement
• Ability to evaluate efficacy, safety, discussion, and conclusion narratives
• Skill tracing clinical claims to TFLs, protocols, tables, figures, and listings
• Strong written and verbal communication for structured, actionable feedback

Helpful Background

An advanced degree in life sciences, pharmacy, or medicine, such as a PhD, PharmD, MD, or MSc, is valued. Equivalent depth of regulatory authoring experience may also be relevant.

Experience across multiple clinical phases and therapeutic areas is useful, with oncology and haematology expertise especially relevant. Prior AI experience is not required; the work depends on rigorous clinical judgment and regulatory writing knowledge.

• Advanced training in life sciences, pharmacy, or medicine, or equivalent authoring depth
• Experience across multiple clinical phases or therapeutic areas
• Oncology or haematology experience is especially relevant
• Prior AI experience is not required

How This Work Makes an Impact

Clinical documentation AI must be evaluated against scientific evidence, regulatory conventions, and source records. By reviewing generated narratives and creating rigorous evaluation tasks, you will help identify where AI systems perform well and where expert correction is needed.

OpenTrain gives professionals a way to build lasting experience in AI training and data labeling. Your work can become part of a stronger portfolio while contributing to the development of cutting-edge clinical technology.

• Apply specialist regulatory writing judgment to AI-generated content
• Improve the reliability and usefulness of clinical documentation tools
• Develop experience in a fast-growing area of AI training