Quality Review Project Lead
Vor 4 Tagen
About the Company
Novartis Farmacéutica is a leading global healthcare company that uses innovative science and technology to provide treatments and services that extend and save lives.
About the Role
You will be responsible for ensuring delivery and oversight of high quality and timely clinical document management activities for a portfolio of internal, outsourced or business development and licensing studies.
About Your Key Accountabilities
- Responsible for timely assessment of quality and completeness of clinical documents for an assigned portfolio of studies.
- Identify and communicate clinical document risks/trends/patterns and work with key stakeholders to define and implement pragmatic remediations.
- Execute vendor oversight plan, monitor service metrics, and identify opportunities for improvement to the operating model. Act as point of escalation for issues.
About Your Responsibilities
- Drive implementation of Clinical Document Governance Management initiatives, projects and process improvement activities to enhance clinical document management systems, processes and standards at Novartis.
- Provide Audit/Inspection readiness support by driving clinical document quality reviews in preparation for audits/inspections, contributing to root cause analysis identification and creation/delivery of Corrective Action Preventative Actions.
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