- Primary responsibility for collecting documents for Clinical Study Report (CSR) appendices
- Primary responsibility for tracking patient safety narratives for CSRs through writing, review, and finalization
- Critically assess, interpret, and summarize data from clinical studies
- Maintain timelines and workflow of writing assignments
- Good written English language skill
- Understanding of clinical data
- Exceptional writing skills are a must
- Excellent organizational skills and the ability to multi-task are essential prerequisites
Patient Narrative Writer
A patient narrative writer writes a brief summary of specified events experienced by patients, during the course of a clinical trial.
This includes multiple tasks such as generation of patient profiles, review of data sources, and identification of events, which is a requirement for a narrative report.
Our clients outsource these tasks in order to leverage the expertise of service providers which in turn requires effective management of cost, time, resources, quality, and the overall project.
The narratives are included as proof to the clinical study report and are submitted to the regulatory authorities as a part of the dossier because it supports as a safety profile of the drug understudied.