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Apply to JobJob ID251038BRPosition TitleExternal Development Operations Relationship LeadJob DescriptionReporting to the GH ERM, the EDO Relationship Lead is responsible for the management of outsourced activities and deliverables of one or more supported External Relationship Management Teams (ERMT).



1. Working within a matrix environment, the Expert EDO Relationship Lead is accountable for all operational aspects of 1 or more ERMTs

2. Supplier Service or Equipment expert within the assigned services within the ERMTs to drive value beyond cost from Novartis’ external supplier base

3. Supporting the implementation of the agreed outsourcing strategies within the ERMTs

4. Responsible for supplier governance, management and issue management/escalation across GDD and cross-divisionally as required (e.g. NIBR, Sandoz)

5. Function as a point of escalation for supplier issues which cannot be resolved at the individual Clinical Trial Teams (CTTs) level

6. Leverage knowledge, experience and understanding of service category(s) and suppliers to provide support to the operational management within the ERMT(s)

7. Lead supplier due diligence activities with ERMT(s)



Major Activities:



Responsible for:

o Management of issue documentation, escalation, and resolution for matters which cannot be resolved at the CTT level; providing direction to CTTs for service specific standards and training

o Drive root cause analysis of supplier performance issues and look for trending across supplier and service category

o Lead ERMT Governance and business review meetings, including documentation and communication of supplier performance, meeting logistics and minutes

o Deputize for EDO UH in leading and managing ERMT owned activities

o Accountable to maintain appropriate ERMT service-specific content for Study Specifications Worksheet (SSW) templates

o Function as category expert providing expertise and training to EDO Service Leads on category strategy, SSW content and use, service standards, and special considerations

o Drive the creation of Novartis standards within a service / functional area

o Ensures compliance with all required SOPs and business guidance documents

o Promote ERMT supplier strategy; facilitate supplier selection across the GDD portfolio

o Act as a coach and mentor to Senior EDO Relationship Lead associates

o Leadership, as needed, in ERMT audit / inspection readiness activities



Provide support for:

o Process improvement and optimization within Novartis and supplier

o Collection and assessment of Key Performance / Key Quality Indicators (KPIs/KQIs)

o Training for internal stakeholders on EDO processes and systems

o Promoting the EDO agenda across GDD through consistent communication of EDO goals and achievements

o Outsourcing initiatives in collaboration with R&D Procurement

o Support EDO Relationship lead with award recommendations to CTTs and Global Clinical Teams (GCTs) based on business requirements

o Development of supplier management plans within ERMT(s) including appropriate governance structures

o Process improvement and harmonization across divisions and functions to ensure compliance with all Novartis policies and procedures



Lead supplier due diligence activities, as required

o Timely oversight, completion, and management of assigned supplier qualification and re-qualification requirements

o Accountable for quality and completeness of qualification and governance documentation in EDO systems

o Manage and maintain due diligence document templates and toolsMinimum requirementsEducation (minimum/desirable):

• Minimum of a Bachelor’s degree in a relevant field, such as a scientific or health care discipline



Languages:

• Fluent English (oral and written)



Experience/Professional requirement:

• 10+ years working experience and excellent knowledge of the clinical operation processes and supplier related activities

• Excellent knowledge of GxP and ICH regulations

• Expert knowledge of clinical trial design and mapping to supplier requirements

• Thorough and technical understanding of Novartis specifications for supplier provided services

• Demonstrated leadership with supplier relationship management and/or expert knowledge of specific service areas

• Demonstrated partnering across divisions with internal and external stakeholders

• Demonstrated root cause analysis, problem solving, and solution generation skills

• History of successfully working in a cross-functional global team and proven ability to function in matrix structure organization

• Leadership to deliver projects according to required and deliverables

• Excellent influencing and communication skills

• Experience or expertise in one or more of the EDO Role accountabilities (e.g. global process ownership, business system owner, SOP & FMR management, global training (all divisions, all countries) on supplier related SOPs and processes)DivisionGlobal Drug DevelopmentBusiness UnitGDO GDDLocationSwitzerlandSiteBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaResearch & DevelopmentJob TypeFull TimeEmployment TypeRegular

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