Overview

Responsible for preparation and review of clinical documents such as patient safety narratives and clinical study report (CSR) appendices. Responsible for preparing lower complexity documents such as synoptic or abbreviated CSRs under guidance of more senior staff. Assist Medical Writers in the preparation and background writing of clinical study protocols, CSRs, and subject narratives. Ensure timely delivery of high-quality documents to internal customers and Sponsors. Assist Medical Writers in the archiving and filing of clinical study protocols and CSRs and associated documentation. Foster excellent working relationships with all clients, both internal and external, with the highest quality of service in a cost-effective manner on time, every time.

Summary Of Responsibilities

• Prepare and review patient safety narratives.
• Provide support to project management of narrative projects.
• Prepare and compile CSR appendices.