Senior IT Analyst II – IT Research and Development

🕒 August 24

🇺🇸 United States – Remote

💵 $157.8k - $195k / year

⏰ Full Time

🟠 Senior

🧐 Analyst

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 20%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 a trusted IT System Owner to Regulatory R&D business units • Establish and maintain IT roadmaps aligned with business demand and project updates • Monitor technology advancements in regulatory operations and introduce relevant trends • Lead system maintenance and enhancement requests, including impact assessments, design, prioritization and sprint planning • Review technical specifications and designs to ensure scalable, optimal solutions • Oversee implementation lifecycles, collaborate with vendors to resolve issues, and manage release planning and IT change requests • Own production support, incident management, problem and service management, and performance monitoring for Regulatory IT R&D systems • Deliver technical integrations with business, IT Security, Infrastructure and Data Management teams • Drive 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 IT Projects 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 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 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 • Pharmaceutical industry experience preferred • Working knowledge of 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 ability to troubleshoot issues independently and prioritize solution-delivery steps • Forward thinking, self-motivated, results-driven approach • Good organizational 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 • Annual bonus • Equity incentives