Title: GCS Document Specialist
Summary:
- Contributes to the planning and ongoing delivery of investigational products by managing the supply chain, supporting the execution of studies and changes to the plans, including carrying out risk assessments and contingency planning where necessary, in support of Clinical Therapy Area and non Clinical Therapy Area projects.
- This is a Clinical Supply support role position, working directly with the Clinical Supply Manager to complete documentations in support of varying clinical activities.
Day-to-day Operations:
- Collaborate with CSMs on maintenance of GCS operations-related documents for all active and upcoming studies (list below). Examples: checking for most current document versions, ensuring approval completeness, maintaining list of key study contacts, etc.
- Ensure accuracy and completeness of GCS study documents in team storage space (BOX and Sharepoint) by performing regular filing, review, and organization of controlled documents.
- Assist CSMs in managing document review and approval in DocuSign/ Adobe e-Sign.
- Interface with internal Alexion functions and external vendors (Almac, Catalent, PCI, Endpoint, etc) to obtain and maintain GCS study documents generated in day-to-day GCS operations.
- Streamline process for document storage and archiving across GCS studies by identifying and driving areas of improvement.
Inspection Readiness Support:
- Support CSMs during audit and inspection activities by compiling and requesting study documents in anticipation of auditor/inspectors’ requests. Typically documents not already in BOX study folders.
- Collaborate with TMF specialist to ensure all TMF filings are accurate and contemporized for all GCS studies, particularly ahead of study audits and inspections.
- Assist CSMs with Storyboard creation and maintenance via communicating with involved functions and reviewing related study documents and/or TrackWise report.
Potential Areas of Support:
- Act as the GCS POC for document storage transition from Alexion BOX to AstraZeneca BOX and OneDrive.
- Create and maintain GCS documents in Vault, the GMP environment.
- Assist with PO requests in terms of Smartsheet submission and quote approval in Coupa.