Sanofi

Preparation and submission of post approval variations and send proper communication for implementation of the change. Co-ordination with GRA, Country regulatory affiliates and COE for submission of dossier and supporting the required documentations.

Basic knowledge of clinical development, GCP & ICH guidelines, regulations by major regulatory bodies such as FDA, Food and Drug Administration and EMA, European Medicines Agency, and SOPs/ QDs. Review study team-developed documents as per SOP, such as study id card, protocol, amendments, WSI, eCRF Case Report Form and completion guidelines, Centralized Monitoring Plan, committee charters and or other operational documents as requested to provide operational input.

Ensure process is in place to maintain the PV QD Training Matrix, training curriculum updated. Ensure global traceability and monitoring of investigations of all identified quality gaps, quality risks and ensure that Corrective and preventive Action Plans are implemented in timely manner.

Verify the accuracy of transcribed data by cross-referencing with original sources and ensure an accurate presentation of data in the report. Ensure that all transcribed data complies with internal quality standards and external regulatory requirements.

He, she will be responsible for providing Therapeutic Area workstream leads with administrative support on pre-defined projects. The Project Manager will set and develop the operational aspects of the project, develop, and monitor timelines, milestones and project metrics and is responsible for managing the projects from an operational perspective from the development and initiation phases through implementation and completion within scope provided by Medical Directors who remains responsible and accountable for the project content.

Responsible for project management support and to ensure the end-to-end effective project delivery of the designated publication, medical education deliverable across all phases. Initiate and amend submission based on comments

Risk-based monitoring is an adaptive approach to clinical trial monitoring that directs focus and activities to critical data and processes that have the most potential to impact patient safety and data quality.

Bachelors degree or above, preferably in a life science or drug development related field. Ensure data quality by conducting data management activities including data validation, data review, etc. following study timelines. Maintain clear reporting on DM activities in alignment with study teams and management needs.

Bachelor or Masters in Life Sciences, Healthcare, Business Administration, Engineering or Information Technology. Handle Product Technical Complaints and Field Alerts for medical devices, pharmaceutical products, biologics, and combination products, ensuring compliance with regulatory standards.