Pharmaceutical Regulatory Medical Writer

About OpenTrain

OpenTrain AI is the hiring and contracting organization for this opportunity. OpenTrain is the #1 platform for finding and building careers in AI training and data labeling, helping contributors discover projects, build a professional profile, and grow their experience in a fast-moving industry.

In this role, your regulatory medical writing expertise will help improve AI systems that support clinical documentation and scientific communication.

About AI Training Work

AI training is the human work behind modern artificial intelligence. Specialists author examples, review model-generated content, identify errors, and explain what high-quality output should look like so AI systems become more accurate and useful.

This opportunity applies that process to pharmaceutical regulatory writing. Your clinical and regulatory judgment will help assess whether AI-generated documents are scientifically sound, well organized, and supported by source materials.

The Role

OpenTrain AI is seeking a Pharmaceutical Regulatory Medical Writer for a remote, part-time contractor opportunity. You will author and review realistic evaluation tasks based on Clinical Study Reports, DSURs, PSURs, PBRERs, and related clinical documents.

The expected workload is 20 or more hours per week. The pay range is $30 to $60 per hour, and the role is available to eligible applicants in the listed countries.

• Work arrangement: Remote contractor
• Schedule: 20+ hours per week
• Pay: $30 to $60 per hour
• Language: English
• Work type: Part-time contract

What You’ll Do

You will evaluate the quality, structure, and scientific accuracy of AI-assisted clinical and regulatory content. Your reviews will help identify weaknesses in model behavior and create clearer standards for regulatory medical writing.

You will also provide structured, actionable rationales that explain errors and support improvements to AI-generated documentation.

• Author and review evaluation tasks based on Clinical Study Reports, DSURs, PSURs, PBRERs, and related clinical documents.
• Assess document organization, section sequencing, cross-referencing, and appendix management against ICH E3 and clinical document conventions.
• Evaluate efficacy, safety, discussion, and conclusion narratives for scientific and interpretive accuracy.
• Trace claims to tables, figures, listings, protocols, and other source records to verify that they are supported.
• Identify divergence between narrative content and source data.
• Distinguish scientific or interpretive errors from acceptable stylistic variation.
• Write clear rationales that enable improvement of AI model behavior.
• Help refine evaluation frameworks and document best practices for regulatory medical writing.

Requirements

This opportunity is categorized as entry level in the listing metadata, but the role requirements call for substantial professional experience. You must have at least five years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant.

Prior AI experience is not required. The work depends on strong regulatory authoring expertise, careful source-data review, and sound clinical judgment.

• At least five years of regulatory medical writing experience.
• Direct experience independently authoring or leading complete Clinical Study Reports.
• Working knowledge of ICH E3 structure, ICH E2F and ICH E2C safety documentation, and eCTD placement conventions.
• Ability to interpret tables, figures, listings, and protocols and trace clinical claims back to source data.
• Ability to identify differences between narrative statements and underlying source data.
• Judgment to distinguish scientific or interpretive errors from acceptable stylistic variation.
• Excellent written and verbal communication for structured, actionable feedback.
• Advanced training in life sciences, pharmacy, or medicine, or equivalent depth of regulatory authoring experience.

Helpful Background

An advanced degree in life sciences, pharmacy, or medicine is valued, including a PhD, PharmD, MD, or MSc. Experience across multiple clinical phases and therapeutic areas is useful.

Oncology and haematology expertise are especially relevant to this work, though the central requirement is demonstrated regulatory medical writing experience and the ability to apply clinical judgment.

• PhD, PharmD, MD, MSc, or comparable advanced training.
• Experience across multiple clinical phases.
• Experience across multiple therapeutic areas.
• Oncology or haematology expertise.

Why Work With OpenTrain

AI training is a flexible way for experienced professionals to contribute directly to the development of cutting-edge systems. OpenTrain helps you build a lasting portfolio of AI training work while applying the expertise you already use in your career.

Creating an OpenTrain account is free, and a strong profile can help you present credible experience, find relevant opportunities, and grow into longer-term work in AI training and data labeling.

• Remote work with flexible, part-time scheduling.
• Apply your regulatory medical writing expertise to emerging AI systems.
• Build a professional portfolio of specialized AI training work.
• Create an OpenTrain account for free and apply in minutes.