Prepare and review clinical documents within established timelines that are of high quality for scientific content, data accuracy, and in compliance with regulatory guidelines, standard operating procedure (SOP), templates and style guides.
Conduct effective project management activities for clinical documents so as to ensure seamless delivery and high levels of customer satisfaction.
Drive process efficiencies.
Impart knowledge of documented guidelines and SOP standards.
The key responsibilities of this position are
Draft clinical documents in accordance with documented guidelines, SOPs and timelines. Ensure that the data is objectively and accurately represented. Responsible for the final deliverable in terms of timelines and quality.
Perform quality check and/or review of clinical documents.
Perform literature search and project management activities for the project/ document assigned.
Ensure that documents are approved and issued as per timelines and comply with established standards and performance metrics.
Timely Documentation and archival of deliverables.
Work effectively with other writers, communicating project information in a timely manner.