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Technical Lead, Clinical Systems IT

Company: Ultragenyx Pharmaceuticals
Location: Somerville
Posted on: June 16, 2022

Job Description:

Why Join Us?Be a hero for our rare disease patientsAt 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. During the COVID-19 pandemic, we are committed to the health and safety of our employees and prospective employees, which means at this time our interview processes may include virtual discussions, interviews, and onboarding. Please note that compliance with local regulations and safety protocols is a condition of employment at Ultragenyx. Elements of safety protocols may include, but are not limited to: work from home requirements, regular or symptom-based covid testing, providing valid evidence of vaccination, mask wearing, and physical distancing.US based roles: Full vaccination against COVID-19 is a condition of employment at Ultragenyx. This requirement applies to almost all roles at Ultragenyx based in the U.S., with very limited exceptions. If you are unable to receive a COVID-19 vaccine due to a disability, serious medical condition, or because it would violate your sincerely held religious belief, you will have an opportunity to request a reasonable accommodation. - Roles based outside the US: - If the role requires travel to the US or another country that requires evidence of covid vaccination for entry, candidates and employees will be required follow the local regulations and corporate policy regarding vaccination evidence submission.Position Summary:ultrafocused - Work together to fearlessly uncover new possibilitiesThe IT Analyst II will serve as the Technical Lead for Clinical systems, playing a key role in deployment, maintenance and enhancement of Information Technology (IT) Research and Development (R&D) systems for Global Development Organization (GDO) and Regulatory Operations departments. - The ideal candidate will be experienced in Release Management, Production Support, and system support of hosted and Saas systems. As Clinical System Owner for, this position ensures both business and technical are appropriately translated into technical solutions and the systems are functioning per requirements. Work Model:Flex: can complete work from home during the pandemic; once return to the office 2-3 days in office to be expected and established with manager.Responsibilities: Serve as IT Technical Lead, supporting cross-functional stakeholders from Global Development Organization (GDO) and Regulatory Operations departmentsProvide technical oversight, support, and expertise for managing day-to-day activities including implementation, maintenance, enhancements and support all systemsOwn Clinical R&D systems' incident management, problem management, and performance monitoringLead Maintenance and Enhancement (M&E) process, defining M&E requests from business, assessment impact and prioritization, determining expected go-live date and preceding milestones, creating release plan, owning IT Change Request, and driving the implementation processAnalyze the impact of changes to assigned GxP and non-GxP IT systems Provide technical oversight on IT projects and initiatives, including vendor selecting, -systems implementation, upgrades, defect fixes and enhancementsResponsible for the incident and problem management processes for Functional Departments'platforms, systems, applications, and servicesParticipate in contract reviews, service level agreement (SLA) negotiations and system/service reviews with multiple IT vendorsWork with vendors to perform requirements walkthrough, technical reviews, testing in Production and non-Production environmentsCollaborate with IT and functional counterparts to respond flexibly and adaptively to the system needs of the business users, with a focus on continuous improvementPerform all activities in compliance with relevant requirements/standards and controls (e.g., GxP,HIPAA, GDPR, CCPA)Requirements: Bachelor's degree in Information Technology, Computer Systems, Information Systems or related field from a 4-year accredited institution4+ years of relevant experience working with IT R&D systems. Experience with one or more of the following systems preferred: eTMF, CTMS, IRT/IxRS, eDiary, Wearables, eConsent, Publishing, RIM, etc)Ability to lead cross-functional teams and change initiatives through implementation with minimal oversight Experience as a system owner preferredExperience in pharmaceutical or medical device industry preferredStrong knowledge of GxP systems and their requirementsExcellent analytical skills required for requirements analysis and troubleshooting/triaging of issues Ability to effectively document/communicate business requirements to system vendorsExperience with testing applications based on requirements needed Excellent verbal and written communications skillsGood organization skills, ability to manage multiple tasksHighly self-motivated and adopts a results -driven approach#LI-NJ1Full 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 countryUltragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If you have any difficulty using our online application system and need an accommodation due to a disability, you may contact -Talent Acquisition -by calling: -(415) 483-8800 -or by -emailing -us at For electronic email and mail inquiries, please include a description of your requested accommodation, your name and contact information.See our -CCPA Employee and Applicant Privacy Notice.See our -Privacy Policy.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:, CA, Novato, CA, or Cambridge, MA /Ultragenyx - IT R&D /Full-time

Keywords: Ultragenyx Pharmaceuticals, Somerville , Technical Lead, Clinical Systems IT, Healthcare , Somerville, Massachusetts

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