332874BR
May 24, 2022
India

Job Description

Your responsibilities include, but are not limited to:

• Working within a matrix environment, the Expert EDO Relationship Lead is accountable for all operational aspects of 1 or more ERMTs
• Supplier Service or Equipment expert within the assigned services within the ERMTs to drive value beyond cost from Novartis’ external supplier base
• Supporting the implementation of the agreed outsourcing strategies within the ERMTs. Responsible for supplier governance, management and issue management/escalation across GDD and cross-divisionally as required (e.g. NIBR, Sandoz)
• Function as a point of escalation for supplier issues which cannot be resolved at the individual Clinical Trial Teams (CTTs) level. Leverage knowledge, experience and understanding of service category(s) and suppliers to provide support to the operational management within the ERMT(s). Lead supplier due diligence activities with ERMT(s)
• 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. Drive root cause analysis of supplier performance issues and look for trending across supplier and service category
• Lead ERMT Governance and business review meetings, including documentation and communication of supplier performance, meeting logistics and minutes. Deputize for EDO UH in leading and managing ERMT owned activities
• Accountable to maintain appropriate ERMT service-specific content for Study Specifications Worksheet (SSW) templates. Function as category expert providing expertise and training to EDO Service Leads on category strategy, SSW content and use, service standards, and special considerations
• Drive the creation of Novartis standards within a service / functional area. Ensures compliance with all required SOPs and business guidance documents. Promote ERMT supplier strategy; facilitate supplier selection across the GDD portfolio. Act as a coach and mentor to Senior EDO Relationship Lead associates. Leadership, as needed, in ERMT audit / inspection readiness activities.

Diversity & Inclusion / EEO

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

Minimum Requirements

• 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)

Why consider Novartis?

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?

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.

We are Novartis. Join us and help us reimagine medicine.

Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.
Global Drug Development
GDO GDD
India
Hyderabad, AP
Research & Development
Full Time
Regular
No
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332874BR

EDO Relationship Lead

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