Senior It Analyst Ii, R&D
vor 1 Monat
At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.Position Summary:The Sr. IT Analyst II will be the technical lead for Clinical IT systems, serving as the single point of contact within IT for the Global Development Organization (GDO). He/she will play a key role in selection, deployment, maintenance, and enhancement of IT systems supporting the GDO. The ideal candidate will be able to lead selection and implementation of new Clinical Systems, have technical experience in managing Clinical Systems, as well as experience in Business Analysis, Project Management, Computer System Validation/Computer Software Assurance, Release Management, and Production Support of hosted and SaaS clinical 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.Work Model:Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.Responsibilities:Serve as a trusted IT System Owner to the Clinical 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, providing updates on existing projects, and staying on top of technology advancements in the clinical operations area.Lead System Maintenance and Enhancement (M&E), understanding new M&E requests from the business, performing impact assessments on existing functionality, and prioritizing new requests for sprint planning.Review technical specifications and design, providing technical feedback to ensure solutions are scalable and optimal.Oversee the entire life cycle of implementation from a functional and technical standpoint and work with vendors to resolve issues.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 Clinical IT R&D portfolio.Deliver technical integrations by collaborating with business and IT data management teams, owning and driving data mapping requirements and technical requirements for integration endpoints.Participate and provide technical oversight on vendor selection and third-party risk assessment, ensuring GxP compliance on all initiatives.Ensure IT Services and IT Projects costs are managed based on allocated budgets and that the 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 Clinical IT R&D systems. Hands-on experience with the Veeva platform specifically eTMF, CTMS, Payments, IRT/IxRS, eDiary is required.Experience with Imaging systems, eConsent, EDC, SAS, Drug Safety, Wearables, Grant Management systems, etc. is preferred. Proficient with relational databases and reporting tools (e.g., PowerBI, Spotfire).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.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 the pharmaceutical industry preferred with working knowledge of applying validation requirements, including FDA, EMA, GAMP5 and global standards (ICH Q9 and Q10) for regulated software development.Excellent analytical skills for requirements analysis and proven ability to troubleshoot issues independently.Forward-thinking, self-motivated individual who adopts a results-driven approach. Good organization skills, ability to manage multiple tasks.Benefits:Full-time employees across the globe enjoy a range of benefits, including, but not limited to:Generous vacation time and public holidays observed by the company.Long term incentive and Employee stock purchase plans or equivalent offerings.Fitness reimbursement.* Benefits vary by region and country.Equal Opportunity Employer:Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws.
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