Senior IT Analyst II - IT Research and Development

Why Join Us

Be a hero for our rare disease patients. 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.

About the Role

The Sr. IT Analyst II will be the technical lead for Regulatory IT systems, serving as the single point of contact within IT for the Global Regulatory Affairs (GRA) organization. This role plays a key role in the selection, deployment, maintenance, and enhancement of IT systems supporting GRA. The ideal candidate will lead the selection and implementation of new Regulatory Systems, manage regulatory systems technically, and have experience in Business Analysis, Project Management, Computer System Validation/Computer Software Assurance, Release Management, and Production Support of hosted and SaaS regulatory systems.

As the IT System Owner, this position ensures both business and technical requirements are appropriately translated into technical solutions and that systems function as required.

Work Model

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

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 and providing 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 assessments on existing functionality, and design and prioritize new requests for sprint planning.
• Review technical specifications and design, providing technical feedback to ensure the solution is scalable and optimal.
• Oversee the entire lifecycle of implementation from functional and technical standpoints and work with vendors to resolve issues.
• Collaborate with BSO and project teams on roll-out planning by understanding dependencies, approving the release plan, managing the IT Change Request, and driving the overall implementation process.
• Act as the single point of contact for production support, taking 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 the IT R&D portfolio is aligned with business priorities.

Requirements

• Bachelor’s degree in Information Technology, Computer Systems, Information Systems, or a 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 the 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.
• 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 and ability to manage multiple tasks.

Pay

The typical annual salary range for this full-time position is $157,800—$195,000 USD. This range reflects the characteristics of the job, such as required skills and qualifications, and is based on the office location noted in this job posting. The range may also be adjusted based on the applicant's geographic location. This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.

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.
• Volunteer days.
• Long-term incentive and Employee stock purchase plans or equivalent offerings.
• Employee wellbeing benefits.
• Fitness reimbursement.
• Tuition sponsoring.
• Professional development plans.

Benefits vary by region and country.