Job Description
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 .
Position Summary:
ultra focused – Work together to fearlessly uncover new possibilities
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.
Work Model:
Remote: Officially documented as working full-time from home, with travel to Ultragenyx’s offices or other locations on occasion 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, 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
#LI-CS1 #LI-Remote
The typical annual salary range for this full-time position is listed below. 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 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.
Pay Range
$157,800—$195,000 USD
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
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. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at [email protected] .
See our CCPA Employee and Applicant Privacy Notice .
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It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to : [email protected] .
