Medical Writer (Pharmaceutical) - Remote

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

About the role

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.

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.

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