Pharmaceutical Regulatory Medical Writer

You will support AI-assisted clinical documentation by authoring, reviewing, and evaluating regulatory medical writing. Your work will help assess whether AI-generated content is well organized, scientifically accurate, and supported by clinical source records.

• Create realistic evaluation tasks based on Clinical Study Reports, DSURs, PSURs, PBRERs, and related clinical documents.
• Review document structure, section order, cross-references, and appendix handling against ICH E3 and standard 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 confirm that the content is supported.
• Write clear rationales that explain errors and help improve AI model behavior.
• Help refine evaluation frameworks and document best practices for regulatory medical writing.

This is a remote, part-time contractor role for an individual medical writing professional. The listing is marked entry level, but the role itself requires substantial professional experience.

• Pay: $30 to $60 per hour.
• Time: 20 or more hours per week.
• Location:
  
  Remote, with eligibility limited to the countries listed for this role.
• Language:
  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 tables, figures, and listings, read protocols, and identify differences between narratives and source data.
• Communication:
  Strong written and verbal communication skills for structured, actionable feedback.
• Helpful background:
  An advanced degree in life sciences, pharmacy, or medicine, such as a PhD, PharmD, MD, or MSc.
• Additional experience:
  Work across multiple clinical phases and therapeutic areas is useful, with oncology and haematology experience especially relevant.
• AI experience:
  Not required.

AI training is the human work behind systems that generate and evaluate text. Experienced professionals review examples, check accuracy, and explain errors so models can produce more reliable results in specialized fields.