Senior Medical Writer: AI-Driven Clinical Docs (Remote)

RemoteJobsOne; México; A distancia; MXN 748.000 - 1.495.000; Jornada completa

Descripción de la vacante

RemoteJobsOne seeks a Medical Writer (Pharmaceutical) on a contract basis to contribute to AI-assisted clinical documentation projects. You will author and review regulatory documents, ensuring alignment with ICH E3 and related safety reporting standards, drawing on at least five years of regulatory medical writing experience.

The role emphasizes high-quality, evidence-based narratives, traceability to source records, and clear rationales to guide AI model training.

Formación

• Minimum 5 years of regulatory medical writing experience.
• Fluency with ICH E3 conventions and eCTD placement.
• Experience authoring or leading Clinical Study Reports beyond summaries.

Responsabilidades

• Author and review clinical documents to inform AI tool development.
• Assess AI-generated content against ICH E3 structure and references.
• Evaluate scientific accuracy in efficacy and safety sections and flag errors.
• Trace narrative claims to source records and verify supporting data.
• Provide structured rationales to enable AI model improvement.
• Collaborate to refine evaluation frameworks for regulatory writing in AI.

Conocimientos

Regulatory medical writing

ICH E3 knowledge

Clinical Study Reports

Scientific writing

Feedback on clinical content

Educación

Advanced degree in life sciences, pharmacy, or medicine

Descripción del empleo

RemoteJobsOne seeks a Medical Writer (Pharmaceutical) on a contract basis to contribute to AI-assisted clinical documentation projects. You will author and review regulatory documents, ensuring alignment with ICH E3 and related safety reporting standards, drawing on at least five years of regulatory medical writing experience.

The role emphasizes high-quality, evidence-based narratives, traceability to source records, and clear rationales to guide AI model training.