Date Posted: 5/19/2020Apply Now
Job Title: Associate Director, Applications - Information Technology
Location: San Francisco, CA
The Associate Director, IT Applications is a key position in the R&D application group of the IT organization.
This position is responsible for the management, implementation and support of critical systems for our departments (Regulatory Operations, Clinical Development and Data Science and Systems). This position also serves as an IT liaison to the business and translates their business requirements into technical solutions, processes and procedures as appropriate. This role is the hands-on Technology Lead/ System Architect across multiple initiatives, taking on IT System Ownership for identified platforms/systems and collaborating closely with various business departments, other IT resources and our vendors. This role is key to the delivery of current-state system improvements and future-state requirements driving innovation and seeking new technical solutions contributing to the Applications portfolio. Finally, this position provides leadership in system delivery/implementation, ensuring GxP compliance within Our SLC framework, tools and procedures. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.
Works on complex problems or data requires an in-depth evaluation of various factors. Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results. Establishes and assures adherence to budgets, schedule, work plans, and performance requirements. Design and monitor the planning, configuration, deployment and support of our systems: Biometrics- SAS, Veeva eTMF, Regulatory Systems (eCTDXPress, Veeva Submissions), Global Specimen management (GSS), Tableau and other associated systems in support of core R&D, PDM functions and processes (may assist the Clinical Data-warehouses / LIMS platforms if needed).Facilitates sessions for business requirements gathering and design / configuration workshops and provides technical assistance for integration between various systems. Suggests process improvements to reduce operating time, improve efficiency or make data adjustments either through Business process adjustments and/or System changes. Establishes relationships with key Business SMEs, recommends solution and plan, performs complex diagnosis of problems and root causes. Notifies Business and IT Management on all process and system changes including vendor releases, new features, bug fixes and resolutions, providing training related to these items as appropriate. Develops/assists project plans, leads project teams, develops internal procedures (SOPs), tools, and documents to provide a high level of application integrity and availability ensuring timely and effective support. Assists in system documentation including requirements, scope, specifications, test plans and scripts, managing source code and operational run-books and procedures. Participates in product evaluations (RFP/RFI), vendor selection, negotiates price and support options, and fosters vendor partnerships. Responsible for administration, operational support including user, security management, data integrity, and maintaining the validated state of safety applications to ensure compliance to regulatory standards.
Responds to critical issues during off hours when necessary and provides backup for other analysts as required. Responsible for timely closure of Exception reports, CAPAs and Deviations, review and approval of controlled documents, policies, procedures and Work Instructions. Represents as System Owner in the event of Regulatory Audits and Inspections (Internal and External). Stays current with technological developments in Safety space, including reading publications, participating in on-line user communities and attending conferences and workshops.
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