Résumé
About the Role
Major accountabilities:
Interact with various business stakeholders, 3rd party vendors, other IT line functions including Quality / eCompliance and information security for the following
Collection of operational demands/enhancement requests. Overall process level understanding /identify process simplification opportunities and implementation
Constantly update/review application roadmaps, technology modernization, elimination of unused assets. Conduct service review meetings with business/vendors and ensure SLA/KPI adherence
Ensure required training materials are up to date. License management, budget management, contract management for various tools/vendors
Escalation management. Overall quality management, technical security management, User access management. Audit readiness, support for both internal and external audits. Ability to support critical / major incidents (major incident management)
Adherence to GxP compliance processes / requirements / documentation. Management of Quality events, Risks, deviations, periodic reviews
Keep abreast with internal IT systems and documentation requirements, standards (including quality management and IT security), regulatory environments / requirements (if applicable), DDIT Service Portfolio and with industry best practices in leveraging technologies for the business and taking advantage of reusable products, solutions, and services wherever applicable. Additional specification required for testing.
Develop operational cost estimates and complete financial model (costs, savings, revenue opportunities, investment horizon, etc.) Perform change impact assessment and formulate a right and compliant approach to development and deployment of changes.
Ensure implemented solutions are according to specifications and fit for purpose. Keep abreast with internal IT systems and documentation requirements, standards (including quality management and IT security).
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Minimum Requirements:
A minimum of 10+ years of experience in working in the Pharma or IT Industry
A minimum of 8+ years of experience in the Pharma domain
A minimum of 6+ years of experience as a service operations role
Expert understanding of business process analysis & design and system architecture concepts.
Expert understanding of the Clinical Trial Business processes, End to End drug development process experience an advantage.
Expert knowledge of GxP, 21CFR Part 11 and the CSV lifecycle
Knowledge of Clinical Data Platforms, Statistical Computing Environments and Clinical Data Management is desirable
Prior working experience in Clinical Analytics domain and knowledge on business processes is preferred.
Ability to solve complex business process / information challenges. Proficient skills in global teams, collaboration, facilitation, negotiation, working in a matrix environment and conflict resolution.
Working knowledge of product management, agile methodologies an advantage. Exposure/working experience in digital innovation projects/operations is an added advantage.
Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world.
How can we achieve this?
With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
https://talentnetwork.novartis.com/network
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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
