Summary
About the Role
Major accountabilities:
You will act as system owner deputy for Vital/ GXP applications, providing first line system and end user support e.g. incident and service request management.
Liaise with GDD colleagues on changing regulatory requirements and related business process, to ensure knowledge transfer to IT business partners for system enhancements.
Prepare User Requirement and Functional Specifications, Administrative Procedures and Working Instructions to support system implementations.
Be a key business contributor in Technology initiatives e.g. system upgrades, Validation, implementations, and functional enhancements, overseeing and supporting PQ Testing and Application Variations.
Develop, implement and support innovative regulatory strategies and life cycle management of RA systems, managing global projects and initiatives relating to regulatory applications and business processes.
Support user training of RA end users and IT partner. Mentor junior associates.
Your Experience
Degree educated in a relevant discipline with systems related experience in pharmaceuticals (ideally Regulatory Operations)
Effective interpersonal and customer service skills.
Ability to work across multiple levels within a complex organisation, team player and collaborative partner.
Knowledge of worldwide Health Authority submission formats, pharma drug development process and associated document requirements is desirable.
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
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
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
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
