Remote Medical Writer for AI-Driven Regulatory Docs

RemoteJobsOne; Columbus (OH); Remote; USD 41,000 - 83,000; Part time

Job summary

RemoteJobsOne is seeking a Medical Writer (Pharmaceutical) for a fully remote contract role open to qualified candidates in the United States. The position offers hourly pay between $30 and $60 and emphasizes AI-assisted clinical documentation development.

You will author and review clinical documents such as CSRs and related materials, ensure adherence to ICH E3 conventions, and provide structured rationales to guide AI model training, with a focus on regulatory quality and accuracy.

Qualifications

• Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant.
• Experience authoring or leading full Clinical Study Reports.
• Fluency with ICH E3 and conventions for periodic safety documentation (ICH E2F, ICH E2C) and eCTD placement.
• Ability to read and interpret TFLs and protocol documents, identifying where narrative diverges from source data.
• Exceptional written and verbal communication with structured, actionable feedback on clinical content.
• Advanced degree in life sciences, pharmacy, or medicine (PhD/MD/PharmD/MSc).
• Experience across multiple clinical phases; oncology/haematology expertise valued.

Responsibilities

• Author and review evaluation tasks for clinical documents to inform AI tool development.
• Assess AI-generated content against clinical template requirements (ICH E3).
• Evaluate scientific accuracy in narrative sections and compare with source data.
• Trace narrative claims to source records to ensure proper support.
• Provide structured rationales for assessments to aid AI model improvement.
• Collaborate to refine evaluation frameworks and document best practices.

Skills

Regulatory medical writing

Medical writing

Clinical study reports

ICH E3

eCTD

Attention to detail

Education

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

Job description

RemoteJobsOne is seeking a Medical Writer (Pharmaceutical) for a fully remote contract role open to qualified candidates in the United States. The position offers hourly pay between $30 and $60 and emphasizes AI-assisted clinical documentation development.

You will author and review clinical documents such as CSRs and related materials, ensure adherence to ICH E3 conventions, and provide structured rationales to guide AI model training, with a focus on regulatory quality and accuracy.