Senior IT Analyst II – IT Research and Development

🕒 2 dias atrás

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $157.800 - $195.000 / ano

⏰ Tempo Integral

🟠 Sênior

🧐 Analista

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

👻 Score fantasma 0%

O que significa: quão provável esta vaga está aberta sem contratação ativa.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

Candidatar-se

Encontrar Vagas Remotas Similares

Configurar Alerta de Email para Novas Vagas

📊 Verifique sua pontuação de currículo para esta vaga

Melhore suas chances de conseguir uma entrevista verificando sua pontuação de currículo antes de se candidatar.

Enviar Currículo

Ultragenyx

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

Fundada em 2010

🏥 Saúde

💼 Consultoria

📦 Logística

Healthcare • Consulting • Logistics

A Ultragenyx é uma empresa biofarmacêutica dedicada a transformar a vida de pessoas com doenças genéticas raras e ultrarraras. A companhia foca no desenvolvimento e na disponibilização de tratamentos para condições em que não existem terapias atuais, utilizando uma variedade de modalidades terapêuticas adaptadas a cada doença. A Ultragenyx conta com um pipeline clínico robusto e diversificado, com terapias em desenvolvimento para doenças genéticas como a Doença de Wilson, a osteogênese imperfeita e a Síndrome de Angelman. Com uma equipe apaixonada e um compromisso com o advocacy de pacientes, a Ultragenyx busca liderar a vanguarda em terapias pioneiras que gerem impacto significativo nas comunidades de pacientes com doenças raras.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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