363942BR
Sep 15, 2023
Ireland
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.
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
• 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
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
Development
GCO GDD
Ireland
Dublin
Novartis Ireland Limited
United Kingdom
India
Research & Development
Full Time
Regular
No
