About the Role

　　Location: UK, Ireland, HYD or Mumbai India #LI-Hybrid

　　Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

　　About the Role:

　　Effective planning and delivery of releases of Novartis enterprise-wide clinical electronic document management systems (eDMS), partnering with technical vendors, internal IT and business stakeholders.

　　Drives implementation of CDGM initiatives, projects and process improvement activities to enhance the planning and execution of releases of enterprise clinical eDMS at Novartis.

　　o Act as CDGM point of contact for specific releases of eDMS, partnering with CDGM, IT (internal and external) and business stakeholders to plan and deliver releases to clinical eDMS, in line with Novartis technology roadmap, compliance and operational requirements.

　　o Partner with CDGM and business stakeholders to understand business requirements, identify functionality gaps in eDMS and contribute to the planning of future releases through prioritisation of backlog items.

　　o Contribute to activities to ensure efficient processes & integrations of systems with eDMS based on strong understanding of Novartis enterprise systems landscape and in line with compliance and business priorities. Serves as Subject Matter Expert for training materials, formal and informal processes and tracking tools for eDMS release management activities in collaboration with CDM Process team and other key stakeholders

　　o Plan and contribute to agile working methodologies being applied during development cycles to prepare for releases and during post release hypercare period.

　　o Owner or Contributor of activities related to release related Incident Management, Change Management and ongoing operations of the eDMS.

　　o Support forecasting of internal resource allocations and vendor provided activities as part of eDMS release management.

　　o Executes vendor oversight plan, monitors service metrics and identifies opportunities for improvement to the operating model. Acts as point of escalation for issues.

　　o Provides support for inspections/audits, contributes to root cause analysis identification and creation/delivery of CAPAs.

　　Diversity & Inclusion / EEO

　　Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

　　Role Requirements

　　• Bachelor's degree or equivalent and relevant industry experience

　　• Minimum of 6 years working in Pharmaceuticals, Lifesciences and Clinical Research with specific experience in managing releases of clinical document management, TMF and/or records & information management.

　　• Minimum 1 year of Veeva related hands on and provable experience in leading and planning of releases for Veeva and Internal business.

　　• Prior experience in Electronic Document Management systems, specifically in Clinical and Regulatory highly desired.

　　• Business relevant technical and working experience of eDMS systems like Veeva Clinical vault, RIM, Documentum D2LS or similar

　　• Knowledge of industrywide Electronic and Clinical Document Management systems and features

　　• Working knowledge of incident management and hyper care principles post releases

　　• Deep knowledge of Agile way of working with cross functional teams for releases

　　• Strong influencing and presentation skills. Ability to communicate effectively at all levels.

　　• High organisational awareness, including experience working in multi disciplinary teams, across cultures and geographies.

　　• Good negotiation, problem solving and conflict resolution skills; experience establishing trusted relationships with internal and external stakeholders.

　　Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

　　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

　　You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

　　Imagine what you could do at Novartis!

　　Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

　　Novartis Ireland Ltd. has been certified as a Top Employer 2022 by the Top Employers Institute for its exceptional employee offerings!

　　#LI-Hybrid

　　Division

　　Development

　　Business Unit

　　GCO GDD

　　Location

　　Ireland

　　Site

　　Dublin

　　Company / Legal Entity

　　Novartis Ireland Limited

　　Alternative Location 1

　　United Kingdom

　　Alternative Location 2

　　India

　　Functional Area

　　Research & Development

　　Job Type

　　Full Time

　　Employment Type

　　Regular

　　Shift Work

　　No