Remote Medical Writer – Pharmaceutical (USD $30‑60/hr)

About the role

This contractor position supports the development of AI‑assisted tools for clinical documentation. The role is fully remote and is aimed at experienced regulatory medical writers who can evaluate and improve pharmaceutical writing tasks.

Key responsibilities

• Author and review evaluation tasks based on Clinical Study Reports, DSURs, PSURs/PBRERs and related clinical documents.
• Assess AI‑generated regulatory content for scientific accuracy, document structure, source support and compliance with ICH conventions.
• Verify narrative claims against tables, figures, listings, protocols and source records.
• Provide structured written feedback and collaborate on evaluation frameworks and best‑practice guidelines.

Required profile

• Minimum 5 years of regulatory medical writing experience at a sponsor, CRO or as an independent contractor.
• Direct experience authoring or leading complete Clinical Study Reports and interpreting TFLs and protocols.
• Strong written and verbal communication skills.
• Advanced degree in life sciences, pharmacy or medicine (PhD, PharmD, MD, MSc) or equivalent authoring experience.

Required skills

• ICH E3, ICH E2F, ICH E2C
• eCTD knowledge
• Clinical Study Report authoring
• Source data verification
• Clinical protocol interpretation
• TFL analysis
• Scientific accuracy assessment
• AI‑assisted documentation evaluation