Compliance and Operations Manager - Epidemiology

Novartis

Novartis

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Legal, Operations
Spain
Posted on Friday, February 9, 2024
Location: Barcelona or Madrid (Hybrid)

The Compliance & Operations Manager enables quality and operational oversight of regulatory commitments and compliance with relevant research policies including managing the scientific, operational and technical quality review process for Quantitative Safety & Epidemiology’s (QSE) deliverables. This role is part of the QSE team and reports to the Global Head QSE.

Key Responsibilities:
• Independently organize the operations, planning and contracting with external partners for QSE non-interventional studies (NIS).
• Develop tools and training to track compliance with Novartis SOPs and with the scientific and technical quality review process within QSE.
• Track audit readiness of QSE deliverables, including maintenance of Trial Master File with required documents.
• Develop innovative ideas/plans (e.g., automated tools) for compliance with Novartis SOPs and policies based on a comprehensive knowledge of non-interventional safety study requirements. Collaborate with relevant line functions including RWE-generating functions, QA, procurement, Global Development Operations (GDO), legal, and External Development Operations (EDO) for operational effectiveness and excellence.
• Create metrices for tracking the status of NIS to support study update presentations to PS & PV leadership.
• Track QSE initiatives and achievements over the year.
• Drive continuous process optimization and simplification to improve QSE productivity and overall performance.
• Lead project management support for QSE NIS and QSE innovative projects.

This role can be based in Barcelona or Madrid, Spain. Novartis is unable to offer relocation support for this role: please only apply if one of these locations are accessible for you

This job is no longer accepting applications

See open jobs at Novartis.