Senior IT Analyst II – IT Research and Development

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $157.8k - $195k / year

⏰ Full Time

🟠 Senior

🧐 Analyst

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Ultragenyx

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2010

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Ultragenyx is a biopharmaceutical company dedicated to transforming the lives of individuals with rare and ultrarare genetic diseases. The company focuses on developing and delivering treatments for conditions where no current therapies exist, utilizing a variety of drug modalities tailored to each disease. Ultragenyx boasts a robust and diverse clinical pipeline, with therapies in development for genetic diseases such as Wilson Disease, osteogenesis imperfecta, and Angelman Syndrome. With a passionate team and a commitment to patient advocacy, Ultragenyx aims to lead the way in pioneering therapies that significantly impact rare disease communities.

📋 Description

• Serve as IT System Owner and trusted IT partner to Regulatory R&D business units • Establish and maintain IT roadmaps aligned with business demand and provide project updates • Monitor technology advancements in regulatory operations and introduce relevant trends • Lead system maintenance and enhancements, including impact assessments, design and sprint prioritization • Review technical specifications and designs to ensure scalable, optimal solutions • Oversee implementation lifecycles and collaborate with vendors to resolve issues • Coordinate roll-out planning, dependencies, release plans, IT Change Requests and implementation processes • Own production support, incident management, problem and service management, and performance monitoring • Deliver technical integrations with business, IT Security, Infrastructure and Data Management teams • Own data mapping, integration endpoint requirements, data validation, insert/upsert rules and publishing versus subscription models • Provide technical oversight for vendor selection and third-party risk assessments • Coordinate with IT Compliance to ensure GxP compliance and adherence to GxP, HIPAA, GDPR and CCPA requirements • Manage IT services and project costs within allocated budgets • Align the IT R&D portfolio 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 Veeva Vault RIM suite (Vault Registrations, Vault Submissions, Vault Submissions Archive, Vault Publishing) • Veeva certified Vault owner training and experience is highly recommended • Experience with Lorenz Docubridge, Lorenz eValidator, eCTD Submission Systems, CDER Direct, ESG Webtrader, eSubmission Gateway, Eudralink, IRIS or other regulatory information management or submission publishing systems is preferred • 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 regulatory business processes 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 • Experience in the pharmaceutical industry is preferred • Working knowledge of data standardization requirements including xEVMPD, IDMP and SPOR • Strong knowledge of GxP systems and their requirements • Experience testing applications based on requirements • Excellent analytical skills for requirements analysis and ability to troubleshoot issues independently and prioritize solution-delivery steps • Forward thinking, self-motivated, results-driven approach • Good organization skills and ability to manage multiple tasks

🏖️ Benefits

• 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