About this role
The company is engaging Medical Writers / Clinical Document Authors to participate in a customer’s project focused on developing advanced AI-assisted writing tools for clinical documentation. In this role, you'll apply your expertise to help train next-generation AI systems. Your work will shape how models learn, reason, and perform through high-quality, real-world input.
Requirements
- Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant.
- Direct experience independently authoring or leading the authoring of full Clinical Study Reports, beyond summaries or partial contributions.
- Fluency with ICH E3 and conventions for periodic safety documentation (ICH E2F, ICH E2C) and eCTD placement.
- Demonstrated ability to read and interpret TFLs and protocol documents, identifying where narrative diverges from source data.
- Exceptional written and verbal communication skills, especially in providing structured, actionable feedback on clinical content.
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