Job Description Summary
Job Description Summary
Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape
Responsible for an innovative approach and independent planning and management of complex clinical research activities to demonstrate product efficacy and safety, and preparation of product registration dossiers in accordance with legislation, internal regulations, valuable practice and business objectives
Job Description
Major accountabilities:
• Active participation in development of complex formulations. Setting clinical strategy for projects. Independently plan, manage, and oversee complex clinical studies in accordance with project strategy, resources, timelines, and regulatory and professional standards.
• Lead operation related activities in close collaboration with Group head.
Selection and management of activities performed by contract organizations; cost optimization; professional and regulatory compliance; efficient coordination and management of costs for activities performed by contract organizations.
• Lead, on-board, mentor and guide CD associate(s) and interns for clinical processes and compliance for day-to-day activities as per Sandoz standards and regulatory requirements
• Responsibility for GxP standard implementation and ensuring that these standards are trained on, known, and understood, and that implementation is controlled
• Ensures Self-Inspection and GCP audit readiness.
• Play active role as a member of the clinical development team to continuous harmonization, process improvement initiatives, knowledge sharing, and setting of the excellence framework for clinical research, as well as contributing to implementing the vision and strategy for Product development small mol
📌 Senior Clinical Development Manager (India)
🏢 Sandoz
📍 India
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