Medical Writer (Pharmaceutical) - Remote

Role Title: Medical Writer (Pharmaceutical) Role Type: Contractor Location: Remote

Required Skills

Regulatory Medical Writing | Clinical Study Report Authoring | ICH E3 Guidelines | Scientific Accuracy Assessment | Source Data Verification | Clinical Protocol Interpretation | TFL Analysis | Written Communication | Structured Feedback | Collaborative Problem-Solving | AI-Assisted Documentation Evaluation | ICH E2F / ICH E2C | eCTD Knowledge | Oncology & Haematology

Job Summary

We are seeking experienced Medical Writers to support the development and evaluation of AI-assisted clinical documentation tools. The role involves applying regulatory medical writing expertise to review, assess, and improve AI-generated clinical and safety documentation.

Key Responsibilities

Author and review Clinical Study Reports, DSURs, PSURs/PBRERs, and related regulatory documents.

Evaluate AI-generated content for scientific accuracy, structure, and regulatory compliance.

Verify narrative claims against TFLs, protocols, and source data.

Assess document organization, cross-referencing, and eCTD requirements.

Provide clear, structured feedback to improve AI-generated clinical content.

Collaborate with project teams to develop evaluation standards and best practices.

Qualifications

5+ years of regulatory medical writing experience in a sponsor, CRO, or consulting environment.

Proven experience independently authoring or leading Clinical Study Reports.

Strong knowledge of ICH E3, ICH E2F, ICH E2C, and eCTD requirements.

Ability to interpret clinical protocols, TFLs, and clinical data.

Excellent written communication and analytical skills.

Advanced degree in medicine, pharmacy, life sciences, or equivalent experience.

Oncology or haematology experience is highly valued.

Originally posted on Himalayas