339355BR
May 24, 2022
India

Job Description

300+ this is how many Novartis clinical studies are serviced by external service providers. Reporting to the Global Head External Relationship Management, the External Development Operations Vendor Relationship Lead is responsible for the management of outsourced activities and deliverables of one or more supported External Relationship Management Teams (ERMT). This roles main focus is on Clinical Outcomes Assessments.
Your responsibilities include, but are not limited to:

• 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

• 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

• Drive consistency and compliance with EDO SOPs to ensure supplier documentation and assessments are accurate and compliant with current regulations and quality modules

• Partner closely with global quality and local country contacts to ensure SOPs/Working Practices are in place and timely training and adherence is maintained within EDO and cross-functionally, as required.

• Creation, maintenance and training for EDO tools and templates to support consistency and compliance with EDO SOPs, governance, and operations.

• Represent the EDO group to review and contribute to processes in other GDO units which impact supplier operations.

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, systems, regulatory requirements, and supplier related activities
• 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 stakeholders
• 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
• Quality mind-set and detail oriented to meet or exceed regulatory requirements
Experience in driving process improvements
WHY NOVARTIS

769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Join our Novartis Network : If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Global Drug Development
GDO GDD
India
Hyderabad, AP
Research & Development
Full Time
Regular
No
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339355BR

Expert EDO Spot Lead

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