Sr. IT Analyst II - Regulatory IT Systems

Position Summary:

The Sr. IT Analyst II will be the technical lead for Regulatory IT systems, serve as the single point of contact within IT for the Global Regulatory Affairs (GRA) organization. He/she will play a key role in selection, deployment, maintenance and enhancement of IT systems supporting the Global Regulatory Affairs (GRA) organization. The ideal candidate will be able to lead selection and implementation of new Regulatory Systems, have technical experience in managing regulatory systems as well as experience in Business Analysis, Project Management, Computer System Validation/Computer Software Assurance, Release Management, Production Support of hosted and SaaS regulatory systems. As the IT System Owner, this position will ensure both business and technical requirements are appropriately translated into technical solutions and the systems are functioning per requirements.

Responsibilities:

• Serve as a trusted IT System Owner to the Regulatory R&D business units by clearly understanding their objectives, challenges, and opportunities.
• Establish and maintain IT Roadmaps by aligning with business teams on new demand, provide updates on existing projects. Stay on top of technology advancements in the regulatory operations area and introduce relevant trends to the business.
• Lead System Maintenance and Enhancement (M&E), understand new M&E requests from the business, perform impact assessment on existing functionality and design and prioritize new requests for sprint planning.
• Review technical specifications and design and provide technical feedback to ensure solution is scalable and optimal.
• Oversee entire life cycle of implementation from a functional and technical standpoint and work with vendor to resolve issues. Collaborate with BSO and project team on roll-out planning by understanding dependencies, approving the release plan, managing the IT Change Request, and driving the overall implementation process.
• As the single point of contact for production support, take ownership of systems incident management, problem & service management, and performance monitoring processes for IT systems within the Regulatory IT R&D portfolio.
• Deliver technical integrations by collaborating with business and IT Security, Infrastructure and Data Management teams. Own and drive data mapping requirements, technical requirements for integration endpoints, data validation, rules for insert/upsert and evaluation of publishing vs. subscription models.
• Participate and provide technical oversight on vendor selection and third-party risk assessment. Coordinate and work with IT Compliance to ensure GxP compliance on all initiatives. Perform all activities in compliance with relevant requirements/standards and controls (e.g., GxP, HIPAA, GDPR, CCPA).
• Ensure IT Services and IT Projects costs are managed based on allocated budgets. Ensure IT R&D portfolio is aligned with business priorities.

Requirements:

• Bachelor’s degree in Information Technology, Computer Systems, Information Systems or related field from a 4-year accredited institution.
• 7+ years of relevant experience working with Regulatory IT R&D systems. Hands-on experience with the following systems is required: Veeva Vault RIM suite (Vault Registrations, Vault Submissions, Vault Submissions Archive, Vault Publishing). Veeva certified Vault owner training and experience is highly recommended (will own and manage non-Veeva applications).
• Experience with one or more of the following systems is preferred: Lorenz Docubridge, Lorenz eValidator, eCTD Submission Systems, CDER Direct, ESG Webtrader, eSubmission Gateway, Eudralink, IRIS or other regulatory information management or submission publishing systems.
• Ability to provide solutions at a technical level and review technical solutions recommended by vendors. Experience with System Development Lifecycle (SDLC) in a regulated environment.
• Experience in business processes for regulatory such as submission planning and tracking, registration management, commitment management and content management.
• Track record of leading multi-level, cross-functional teams (including vendors and MSPs) within a matrix environment to deliver complex IT initiatives with minimal oversight.
• Experience in pharmaceutical industry preferred with working knowledge of applying data standardization requirements including xEVMPD, IDMP, SPOR. Strong knowledge of GxP systems and their requirements. Experience with testing applications based on requirements is needed.
• Excellent analytical skills for requirements analysis and proven ability to troubleshoot issues independently and prioritize steps in delivering solutions.
• Forward thinking, self-motivated individual who adopts a results-driven approach. Good organization skills, ability to manage multiple tasks.

Work Model:

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.