Document specialist

NOTE : THIS IS A CONTRACT POSITION

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

a. 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 reports

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

Key GCS study documents :

Packaging / Labeling / Distribution

Request for Packaging (Blinded and Unblinded RFP), Variable Data Request, Label Links and Rand

Packaging Specifications (PS), Certificate of Compliance / Conformance (CoC), Certificate of Analysis

CoA), Certificate of Testing (CoT), Partial Manufacturing Certificate, QP certificates, IMP release

IRT specifications (Endpoint PULSE and Almac IXRS), Endpoint DRIVE Specifications, User Acceptance

Test (UAT) Log, IRT User guides, DRIVE User Manual, Drug Return Instructions (DRI), Data Change Requests (DCR), IRT Report for Returns Discrepancy, IRT Validation Certificate

• Audit trail report requests for site / user changes for audits and inspections

Last updated : 2024-06-20