Pharmaceutical Regulatory Medical Writer

You will create and review realistic evaluation tasks for AI-assisted clinical documentation. The work focuses on Clinical Study Reports, DSURs, PSURs, PBRERs, and related regulatory medical documents.

You will judge whether clinical content is well organized, scientifically accurate, and supported by source records. You will also explain errors clearly so AI systems can improve their regulatory writing.

You will help refine evaluation frameworks and record best practices for regulatory medical writing.

• Author and review evaluation tasks based on Clinical Study Reports, DSURs, PSURs, PBRERs, and related documents.
• Assess section order, organization, cross-references, and appendix handling against ICH E3 and clinical document conventions.
• Review efficacy, safety, discussion, and conclusion narratives for scientific and interpretive accuracy.
• Trace claims to tables, figures, listings, protocols, and other source records.
• Write clear, actionable rationales explaining errors and opportunities to improve AI model behavior.

What It Pays And Takes

This is a remote, part-time contractor role for an individual medical writing professional. English fluency is required, and the role is open to candidates in the countries listed below.

• Pay: $30 to $60 per hour.
• Time: 20 or more hours per week.
• Work arrangement: Remote contractor role.
• Language: English fluency required.
• Location: Open to candidates in Argentina, Austria, Bangladesh, Belgium, Bahrain, Brazil, Canada, Switzerland, Chile, Colombia, Germany, Denmark, Algeria, Egypt, Spain, Ethiopia, France, the United Kingdom, Ghana, Greece, Indonesia, India, Italy, Jordan, Japan, Kenya, Kyrgyzstan, Kuwait, Kazakhstan,
• Experience: At least five years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant.
• Clinical writing: Direct experience independently authoring or leading complete Clinical Study Reports.
• Regulatory knowledge: Fluency in ICH E3, ICH E2F, ICH E2C, and eCTD placement conventions.
• Analysis: Ability to interpret tables, figures, and listings and compare narratives with protocols and source data.
• Communication: Strong written and verbal communication for structured, actionable feedback.
• Helpful background: An advanced degree in life sciences, pharmacy, or medicine, including a PhD, PharmD, MD, or MSc, is valued. Experience across multiple clinical phases and therapeutic areas is useful, especially oncology and haematology experience.
• Prior AI experience is not required.

How It Works

Apply on OpenTrain with your resume, then complete the application on the hiring site.

About AI Training Work

AI training work uses human-written and human-reviewed examples to improve how AI systems respond. Regulatory medical writers are needed because strong clinical and scientific judgment helps assess whether generated documents are accurate, well supported, and suitable for their intended use.