Description:
You will assist in projects and initiatives related to AstraZeneca integration and/or resulting from the analysis of the performance metrics, and cultivate collaborative relationships with key stakeholders, such as Global Patient Safety, Global Operations and AstraZeneca, to support data and reporting.
You Will Be Responsible For
- Creating GRA analytic processes and reporting mechanisms to evaluate GRA performance and identify and mitigate risks (for example risks associated with Alexion and AstraZeneca interfaces).
- Creating dedicated Veeva RIM Reports to review for (but not limited to);
- Incomplete data fields
- Lifecycle states not updated
- Compliant upload of HA Correspondence
- Incomplete Activity records and monitor for alignment with Quality Management system tools (i.e. Regulatory Affairs Change Controls)
- Supporting GRA submission leads and Regulatory Project Management (RPM) to ensure Veeva RIM records are set up correctly
- Monitoring Health Authority interactions and their communication to stakeholders, and manage the distribution and communication of Veeva RIM reports as appropriate
- Analyzing Veeva RIM outputs and present to senior management
- Contributing to GRA RIM team implementations, with a focus on ensuring appropriate systems/processes are in place for performance oversight
- Assisting in implementing and maintaining processes aligned with applicable policies and standards to report on GRA performance data.
- Performing other related duties and special projects as required or requested. For example internal and regulatory audit and inspection support, or monitoring e2e label compliance