摘要
About the Role
Position Title: Assoc. Dir. DDIT DEV RA Sol. Del
Location – Hyd-India #LI Hybrid
About the Role
The primary objective of this position is to serve as a consultant and advisor, offering expert guidance to enhance complex global business processes, products, and services. We seek a seasoned professional in GDD Regulatory Affairs who will lead both the strategic and operational implementation of Veeva Vault capabilities in the Regulatory area. This role is responsible for ensuring alignment with organizational objectives, regulatory requirements, and enterprise architecture standards, whilst promoting product innovation and managing the lifecycle.
As Associate Director – Solution Delivery, you will be responsible for leading and coordinating all phases of ongoing Veeva implementations, including data management, migration, test planning, execution, cutover, and quality assurance. This role develops and manages detailed project and cutover plans, oversees technical and business go-live activities, ensures data integrity and regulatory compliance, and drives risk mitigation across testing, migration, and release processes. The role collaborates with stakeholders, manages vendor relationships, communicates project status, and ensures successful delivery through effective planning, monitoring, and issue resolution.
Your responsibilities include but are not limited to
• Project Leadership & Planning: Lead and coordinate all phases of the program, including test planning, data migration, cutover, and quality assurance. Develop and manage detailed project and cutover plans, ensuring alignment with overall program timelines and objectives.
• Data Migration & Integrity: Lead data management activities for RA business in terms of data modelling, data analysis, data cleanup and data mapping. Also provide technical support for applications across domains using RA data.
• Data Management: Lead data migration activities, including data cleansing, transformation, validation, and post-migration quality checks to ensure accuracy and completeness. Ensure designed solutions are aligned with Data and Analytics strategy standards and roadmap.
• Stakeholder & Vendor Management: Collaborate with business leaders, IT teams, external vendors, and regulatory stakeholders to gather requirements, manage expectations, and ensure effective communication and coordination across all workstreams.
• Risk & Issue Management: Proactively identify, mitigate, and resolve risks and issues across testing, migration, and cutover phases, developing and implementing effective mitigation strategies.
• Reporting & Documentation: Track project status, cutover execution, and test results; provide regular updates to leadership, highlighting milestones, risks, and resolution strategies. Maintain comprehensive documentation for all processes, procedures, and results.
• Continuous Improvement: Evaluate tools, methodologies, and processes for ongoing improvement, leveraging lessons learned to enhance future implementations.
Bring innovations to the solutions and add measurable values to RA Business. Multi-national global
What you’ll bring to the role:
Experience in interacting with senior management, collaborating across boundaries and relationship management, and influencing without authority
• Experience in Regulatory Affairs business processes is a plus (e.g. Registration Management, Submission Management, Submission Content management, Submission Publishing & Clinical Publishing, Product Labeling)
• Skills: Data management, migration tools, analytical thinking, attention to detail. Project management, planning, leadership, organization, Strategic Planning. Service Delivery Management, Stakeholder engagement, vendor management, communication, collaboration
• Risk management, decision-making, critical thinking. Reporting, documentation, communication, process orientation. Continuous improvement, technical curiosity, openness to feedback. Budget Management, Business Acumen, Influencing Skills.
Desirable Requirements:
• Bachelor's or Master's degree in Computer Science, University degree in Informatics, Computer Sciences, Life Sciences or similar
• 12+ years of IT experience and 4+ years of experience working on data related projects for data management and data analysis activities with o\proven track record in planning and executing large-scale data migrations, including data cleansing, transformation, validation, and post-migration quality checks, preferably within Documentum or Veeva environments.
• Overall experience in cutovers, testing, and migration is highly preferred with hands on experience in Veeva Vault or life sciences/pharma domain is preferred. Implementation experience of Veeva Submission and Submission Archive module is a plus.
• Strong technical background with technologies like Python, Reltio, Data modelling and GxP Projects related Fields are plus
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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