799 million. That's how many lives our products touch. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
Job Purpose (State in one sentence the overall objective of the job)
Reporting to the External Development Operations (EDO) Operations Head, the Expert EDO SPOT Lead is responsible for the creation, implementation and management of EDO systems, processes, and training to support all operational activities within EDO. Drives consistency among EDO Supplier Leads and EDO Relationship leads by ensuring standards are developed and followed. Drives participation and input from contacts in Country Organizations to ensure understanding and adherence of EDO systems, process, and training.
All EDO SPOTs will be responsible to support the operations of the EDO group by performing the following:
• Host forums within EDO (EDO Supplier Leads, EDO Relationship Leads, EDO Development Unit Heads) and outside EDO (country organizations, GDO line units) to ensure consistency, quality, compliance, provide EDO-specific training and promote the EDO mission and requirements
• Support collection and assessment of Key Performance / Key Quality Indicators (KPIs/KQIs) for EDO and supplier data
• Participate in continuous improvement initiatives and other management initiatives
• Support Head Operations with development of communications within and outside of EDO
• Monitors compliance with all required SOPs and business guidance documents
• Coordinate the creation of Novartis standards with support from EDO team members
• Process improvement and harmonization across divisions and functions to ensure compliance with all Novartis policies and procedures
• Coordination of and support for EDO audit / inspection readiness activities
Diversity & Inclusion / EEO
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
• Minimum of a Bachelor's degree in a relevant field, such as a scientific or health care subject area
• 10+ years working experience and excellent knowledge of the clinical operation processes, systems, regulatory requirements, and supplier related activities (preferred)
• Excellent knowledge of GxP and ICH regulations
• Strong knowledge of clinical trial design and mapping to supplier requirements
• Operational excellence within a global organization
• Demonstrated partnering across divisions with internal and external partners
• History of successfully working in a cross-functional global team and proven ability to function in matrix structure organization
Why consider Novartis?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.
Imagine what you could do at Novartis!
Global Drug Development
East Hanover, NJ
Company / Legal Entity
Research & Development