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| Associate GRAAS Operations CA Open (J#27516) Title: Associate GRAAS Operations Company: Amgen Job Summary: This is an opportunity for an Associate in the Publishing group within GRAAS (Global Regulatory Affairs and Safety) Operations. The purpose of this group is to support the creation and filing of global submission components dossiers. Key Responsibilities: Submission of Regulatory Filings for Clinical Trial Applications, Marketing Applications (FDA), and Promotional Labeling (DDMAC) Internal communication regarding regulatory filing status Preparation of Submission Ready Components from internal dossier contributors through the application of electronic navigation according to regional regulatory agency guidance Source document review, formatting, troubleshooting source documents Ensure document conformance to Amgen Style Manual for internal review and approval Compilation of complex documents for internal review and submission (i.e. Clinical Study Reports, Investigator Brochures, Protocols) Template Troubleshooting Maintenance Document Management Communicate submission status to key stakeholders Quality Control of submission ready components and submission dossiers Compilation of paper submissions when necessary (FDA Meeting Packages) Contributes to preparation and compilation of department metrics Contributes to process improvements and training documentation relative to Publishing; May contribute graphics, designs, and ideas for Operational excellence in department documentation and presentations More... | |||
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