14 Nov
|
Merck Group
|
India
Roles and Responsibilities : - Support the definition and maintenance of target architecture and solution designs for Veeva Vault RIM, in alignment with business strategy, enterprise standards, and regulatory requirements.- Contribute to translating business requirements into scalable, secure solutions across Registration, Submissions, Archive, and Publishing.- Design, build, configure, and support Veeva Vault-based applications to meet business process and application requirements, applying MDL, APIs, Direct Data API, Action Triggers, the Veeva SDK, and data flows.- Investigate and solve issues using technical knowledge and experience, support root cause analysis, and coordinate timely resolution, with a moderate level of guidance.- Analyze information and assist in evaluating options, risks, dependencies, and lifecycle impacts, and help recommend solutions that balance compliance, usability, cost, and supportability.- Incorporate security, data integrity, validation, change control, and audit requirements into solution designs.- Maintain architecture decisions, diagrams, standards, and roadmaps, and communicate updates clearly to stakeholders.- Identify and pilot AI and automation opportunities, such as LLM-based assistance for drafting and quality-checking submission content and API-driven automation of data validation and publishing workflows, with human oversight and validated controls.- Prepare communications and deliver presentations on system enhancements and alternatives; evaluate, optimize, harmonize, and standardize existing systems.- Create and update system documentation, monitor quality standards,
ensure failure-free operation, and consider compatibility across systems.- Review and approve regulatory system changes and documentation, and support ongoing regulatory compliance of the IT components for defined services.- Support periodic reviews, audits, and security reviews of the entire system, and compile related reports during the operation phase.- Support the qualification, validation, testing, and documentation related to IT solutions delivery.- Understand how the team integrates with other teams to achieve the overall objectives of the area, and build knowledge of the organization, processes, customers, and key business drivers.Required Expertise :- Extensive experience in Veeva Vault architecture and configuration, particularly within RIM.- In-depth knowledge of Registration, Submissions, Archive, and Publishing processes.- Technical expertise in MDL, APIs, Action Triggers, the Veeva SDK, integrations, and information security.- Experience designing regulated solutions with appropriate validation and change governance.- Experience in testing, validation, change management, and regulated-system documentation.- Strategic mindset with solid stakeholder engagement and communication skills.- Working knowledge of Python, AI/LLMs, and prompt engineering, with sound risk judgment.Education :Bachelor's degree in engineering.Master's degree in computer science is preferred.Experience :- 10+ years of overall experience in IT, with relevant experience in Veeva Vault RIM or comparable regulatory information management platforms. (ref:hirist.tech)
📌 Merck Group - Associate Architect - Veeva Vault RIM (India)
🏢 Merck Group
📍 India