Remote Medical Writer (Regulatory) for AI-Driven Clinical Docs

RemoteJobsOne

Singapore

Remote

SGD 53,000 - 106,000

Full time

6 days ago
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Job summary

RemoteJobsOne is seeking a Medical Writer (Pharmaceutical) for a fully remote contractor role based in Singapore. You will author and review regulatory documents to train AI-assisted writing tools, applying deep domain knowledge to ensure high-quality inputs for model development.

Applicants should have 5+ years in regulatory medical writing, with experience in CSRs and strong knowledge of ICH E3 conventions and eCTD placement.

Qualifications

  • Minimum 5 years of regulatory medical writing experience at sponsor/CRO or as consultant.
  • Experience authoring or leading full Clinical Study Reports, not just summaries.
  • Fluency with ICH E3 and safety documentation conventions (ICH E2F/E2C) and eCTD.
  • Ability to read and interpret protocol documents and source data for narrative accuracy.
  • Strong written and verbal feedback skills on clinical content.

Responsibilities

  • Author and review tasks for CSRs, DSURs, PSURs/PBRERs to inform AI tool development.
  • Assess AI content against clinical template, structure, and cross‑referencing.
  • Evaluate narrative accuracy in efficacy, safety summaries, and conclusions.
  • Trace narrative claims to source records and verify support.
  • Provide structured written rationales to enable model improvement.
  • Collaborate with leads to refine evaluation frameworks for AI‑assisted writing.

Skills

Regulatory medical writing
Clinical study reports
ICH E3 familiarity
AI-assisted clinical writing
Regulatory documentation feedback

Education

Advanced degree in life sciences, pharmacy, or medicine

Job description

RemoteJobsOne is seeking a Medical Writer (Pharmaceutical) for a fully remote contractor role based in Singapore. You will author and review regulatory documents to train AI-assisted writing tools, applying deep domain knowledge to ensure high-quality inputs for model development.

Applicants should have 5+ years in regulatory medical writing, with experience in CSRs and strong knowledge of ICH E3 conventions and eCTD placement.

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