Remote Senior Medical Writer for AI-Regulatory Docs

RemoteJobsOne; Amsterdam; Remote; EUR 36,000 - 73,000; Part time

Job summary

RemoteJobsOne is seeking a Medical Writer (Pharmaceutical) for a fully remote contractor role open to candidates based in the Netherlands. The position focuses on developing AI-assisted clinical documentation support, requiring expertise in regulatory writing and CSR authoring.

You will author and review Clinical Study Reports, assess adherence to ICH E3 conventions, and provide clear, structured rationales tied to source data. Collaboration with project leads is essential.

Qualifications

• Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant.
• 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.

Responsibilities

• Author and review Clinical Study Reports and related regulatory documents to inform AI tool development.
• Assess AI-generated content for compliance with clinical template structure, ICH guidelines, and cross-referencing.
• Evaluate scientific accuracy in narrative sections and distinguish true errors from stylistic differences.
• Trace narrative claims to source records (tables, figures, listings, protocols).
• Provide clear, structured rationales to support assessments and improvements of AI model outputs.
• Collaborate with project leads to refine evaluation frameworks and document best practices for regulatory writing in AI context.

Skills

Regulatory medical writing

CSR authoring

ICH E3 E2F E2C knowledge

Reading and interpreting protocols

Structured, actionable feedback

Clinical phases experience

Oncology/haematology domain knowledge

Education

Advanced degree in life sciences, pharmacy, or medicine (PhD, PharmD, MD, MSc)

Job description

RemoteJobsOne is seeking a Medical Writer (Pharmaceutical) for a fully remote contractor role open to candidates based in the Netherlands. The position focuses on developing AI-assisted clinical documentation support, requiring expertise in regulatory writing and CSR authoring.

You will author and review Clinical Study Reports, assess adherence to ICH E3 conventions, and provide clear, structured rationales tied to source data. Collaboration with project leads is essential.