Pharmaceutical Regulatory Medical Writer

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The Work

You will support the evaluation of AI-assisted clinical documentation. The work focuses on writing and reviewing realistic tasks based on regulatory medical documents, then judging whether AI-generated content is accurate, well organized, and supported by source records.

  • Author and review evaluation tasks based on Clinical Study Reports, DSURs, PSURs, PBRERs, and related clinical documents.
  • Assess document structure, section order, cross-references, and appendix handling against ICH E3 and standard clinical document practices.
  • Review efficacy, safety, discussion, and conclusion narratives for scientific and interpretive accuracy.
  • Trace claims to tables, figures, listings, protocols, and other source records to confirm that the content is supported.
  • Write clear rationales that explain errors and help improve AI model behavior.
  • Help refine evaluation frameworks and document good practices for regulatory medical writing.

What It Pays and Takes

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

  • Pay: $30 to $60 per hour.
  • Work arrangement: Remote, part-time contract work.
  • Location: Open to candidates in Algeria, Argentina, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, Chile, Colombia, Denmark, Egypt, France, Germany, Ghana, Greece, India, Indonesia, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Lebanon, Malaysia, Mexico, Morocco, the Netherlands, Nigeria, Oman, Pakistan, Palestinian Territories, Peru, the Philippines, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Tunisia, the United Arab Emirates, the United Kingdom, the United States, Uzbekistan, and Vietnam.
  • Language: Professional fluency in English.
  • 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.
  • Technical judgment: Ability to interpret TFLs and protocols and identify differences between a narrative and its source data.
  • Communication: Strong written and verbal communication skills for structured, actionable feedback.
  • Helpful background: An advanced degree in life sciences, pharmacy, or medicine, including a PhD, PharmD, MD, or MSc, is valued.
  • Additional useful experience: Work across multiple clinical phases and therapeutic areas, especially oncology and haematology.
  • AI experience is not required.

How It Works

Apply on OpenTrain with your resume, then complete the application on the hiring site. OpenTrain is where people find AI training roles, build a professional profile, and start their application.

About AI Training Work

AI training is the human work behind systems that generate and evaluate text, images, audio, and other content. People with strong professional knowledge review examples, write model tasks, and explain what good output should look like, helping AI systems produce more reliable results.

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