Remote Medical Writer for AI‑Augmented Regulatory Docs

RemoteJobsOne; Brussel; À distance; EUR 36 000 - 73 000; Temps partiel

Résumé du poste

RemoteJobsOne is seeking an experienced Medical Writer (Pharmaceutical) for a fully remote contractor role based in Belgium. You will contribute to AI-assisted clinical documentation and regulatory writing, shaping how models learn from high‑quality real‑world input and ensuring compliance with ICH guidelines.

This high‑caliber position requires 5+ years of regulatory medical writing, fluency with ICH E3 (and E2 series), and an advanced life sciences degree.

Qualifications

• Minimum 5 years of regulatory medical writing experience.
• Experience authoring or leading CSR documents.
• Fluency with ICH E3 and eCTD conventions.
• Ability to interpret clinical trial data and source documents.
• Strong written and verbal communication for actionable feedback.

Responsabilités

• Author and review Clinical Study Reports and related documents.
• Assess AI-generated content for regulatory template and structure conformance.
• Trace narrative claims to source records and verify support.
• Provide clear, structured rationales for assessments.
• Collaborate with project leads to refine evaluation frameworks.

Connaissances

Regulatory medical writing

ICH E3 knowledge

Structured feedback

Clinical study reporting

Analytical reasoning

Formation

Advanced degree in life sciences/medicine/pharmacy

Description du poste

RemoteJobsOne is seeking an experienced Medical Writer (Pharmaceutical) for a fully remote contractor role based in Belgium. You will contribute to AI-assisted clinical documentation and regulatory writing, shaping how models learn from high‑quality real‑world input and ensuring compliance with ICH guidelines.

This high‑caliber position requires 5+ years of regulatory medical writing, fluency with ICH E3 (and E2 series), and an advanced life sciences degree.