Our client in New Jersey seeks a Global Electronic Submission Coordinator. Job Purpose: Provide support, coordination and Quality Assurance (QA) for all Electronic Submission (E-Sub) components to be delivered in compliance with FDA guidance and regulation. Maintain and enhance tools for creating E-sub components. Primary Responsibilities and Accountabilities: Daily management and coordination of all E-Sub deliverables. Direct and timely communication with the PD drug project teams and Regulatory to keep all E-Sub submission timelines up to date. Maintain most current E-Sub timelines and status in a PDIT tracking tool. Responsible for ensuring the E-Sub delivery within negotiated submission timelines. Use a standard QA review process to ensure the accuracy and consistency of the E-Sub deliverables, including review of the data definition document, the annotated CRF, the SAS transport files, the patient list and the SAS program documentation. Application of technology to provide the E-Sub deliverables in compliance with FDA guidelines. This includes creating the hyperlinks between the define document and the annotated CRF and the SAS transport files using existing PDIT linking tools. Ability to enhance or create new linking processes. Provide SAS programming support for E-Sub macro changes and enhancements working in a UNIX environment. Implement new E-Sub macros to automate manual QA processes. Follow change control and validation procedures. Train PD project teams, CROs working for PD project teams and SAS programming E-Sub super users on E-Sub procedures. Support users to effectively make use of the tools and suggest solutions and best practices. Update training materials as needed. Participate in global E-Sub learning forums.

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