Veeva Vault Solution Architect – Clinical, Regulatory, Quality Systems

🕒 Julho 21

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Cristcot

SiteLinkedInTodas as Vagas

11 - 50 funcionários

Fundada em 2008

🏥 Saúde

🏭 Manufatura

💊 Farmacêutico

💰 $10.473.043 Venture Round - Cristcot em 2025-06

Healthcare • Manufacturing • Pharmaceuticals

Cristcot é uma empresa de desenvolvimento e pesquisa farmacêutica especializada em formulações de medicamentos inovadores e tecnologias de combinação de dispositivos medicamentosos discretas projetadas para melhorar a adesão do paciente, reduzir a carga do tratamento e integrar terapias no dia a dia. Fundada em 2008 e sediada em Austin, Texas, a Cristcot oferece design e execução de pesquisa clínica, engenharia de formulações e administração inovadoras, desenvolvimento de ensaios especializados e suporte à estratégia regulatória; sua principal terapia investigacional concluiu um estudo fundamental de Fase 3. A empresa foca em solucionar barreiras negligenciadas no gerenciamento de doenças, criando soluções intuitivas e econômicas que possibilitam um cuidado mais eficaz e confiante.

Descrição

• Serve as the technical subject matter expert for Veeva Clinical, RIM, and Quality applications. • Define solution architecture, configuration standards, integration patterns, and technical governance for the Veeva Vault platform. • Gather and analyze business, technical, data, security, and regulatory requirements and translate them into scalable solution designs. • Lead requirements workshops, architecture sessions, design reviews, and technical decision-making with business and technology stakeholders. • Design and oversee integrations between Veeva Vault and clinical, regulatory, quality, enterprise, and data platforms. • Provide technical oversight for system implementations, enhancements, upgrades, releases, and application lifecycle activities. • Partner with development and implementation teams to review technical designs, APIs, data mappings, migration approaches, and custom components. • Recommend the effective use of standard Veeva capabilities to minimize unnecessary customization and improve maintainability. • Support Computer Software Assurance and Computer System Validation activities, including risk assessments, validation planning, testing, traceability, and change control. • Ensure solutions support applicable requirements, including GxP, 21 CFR Part 11, EU Annex 11, data integrity, security, privacy, records retention, and audit trail requirements.

🎯 Requisitos

• Bachelor’s degree in Information Technology, Computer Science, Engineering, Life Sciences, or a related field. • At least 5 years of experience implementing, architecting, or supporting Veeva Vault solutions in the pharmaceutical, biotechnology, medical device, or life sciences industry. • Strong understanding of Veeva Vault architecture, configuration, security, workflows, object models, reporting, APIs, and integration capabilities. • Current Veeva certification or demonstrated implementation experience in relevant Veeva applications is strongly preferred. • Knowledge of GxP, FDA regulations, 21 CFR Part 11, EU Annex 11, and applicable data integrity requirements. • Ability to manage multiple priorities and work effectively across business, technical, and vendor teams in a fast-paced environment.

🏖️ Benefícios

• None specified