Remote Medical Writer for AI-Driven Clinical Docs

RemoteJobsOne; Kentucky; Remote; USD 41,000 - 83,000; Full time

Job summary

RemoteJobsOne is actively seeking a Medical Writer (Pharmaceutical) to work remotely on a contractor basis. The role focuses on developing AI-assisted tools for clinical documentation, leveraging extensive regulatory writing experience to shape how AI models learn and produce regulatory content.

Requires expertise in CSR authoring and ICH guidelines, with strong attention to source data and narrative accuracy.

Qualifications

• Minimum 5 years of regulatory medical writing experience with sponsor/CRO/consultant.
• Experience authoring full Clinical Study Reports (CSR).
• Fluency with ICH E3 and periodic safety documentation (ICH E2F/E2C) and eCTD placement.
• Ability to read and interpret TFLs and protocol documents.
• Experience across multiple clinical phases; oncology/haematology valued.

Responsibilities

• Author and review CSRs and related clinical documents for AI tool development.
• Assess AI-generated content against clinical templates and ICH structure.
• Evaluate narrative accuracy in efficacy, safety summaries, discussions and conclusions.
• Trace narrative claims to source records to verify support.
• Provide structured, written rationales for assessments to guide AI model improvements.
• Collaborate with project leads to refine evaluation frameworks and best practices.

Skills

Regulatory medical writing

Clinical documentation

Interpretation of clinical data

Education

Advanced life sciences degree

Job description

RemoteJobsOne is actively seeking a Medical Writer (Pharmaceutical) to work remotely on a contractor basis. The role focuses on developing AI-assisted tools for clinical documentation, leveraging extensive regulatory writing experience to shape how AI models learn and produce regulatory content.

Requires expertise in CSR authoring and ICH guidelines, with strong attention to source data and narrative accuracy.