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.