About the role
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