15 Oct
|
Sandoz India
|
India
15 Oct
Sandoz India
India
Major Accountabilities
• Provides medical development input for assigned products and projects, including assessment of preclinical findings, formulation information, device-related considerations, pharmacology, pharmacokinetics, pharmacodynamics, clinical evidence, treatment guidelines, standard of care, regulatory expectations and other relevant medical information. Provides medical expert assessment to support selection and evaluation of new product opportunities, with the aim of enabling scientifically justified, patient-relevant and effective development strategies, including lean clinical strategies where feasible.
• Contributes to product- or indication-specific analysis of internal and external data sources to generate medical insights that support formulation, device, therapy and clinical development decisions and increase the probability of successful product development. Maintains and updates medical assessments, including efficacy, safety, treatment guidelines and standard of care, to support development optimization and regulatory discussions such as scientific advice,
briefing books and paediatric investigation plan-related activities, as applicable.
• Provides medical and development-phase patient safety input to product development teams and relevant development milestones; where required, provides training to other functions on pharmaceutical and medical topics including indication, posology, pharmacokinetics, pharmacodynamics, efficacy and safety. Collaborates with cross-functional partners, including Product Development, Portfolio and Platforms, Global Medical Affairs, Quality, Pharmacovigilance, Regulatory Affairs, BD&L;, SDCs, relevant governance forums and external partners, to support aligned, compliant and timely development deliverables.
• Engages with external experts, Health Authorities and external service providers as required for assigned products or projects, in alignment with project needs and applicable internal processes. Provides i
📌 Global Medical Development Manager (India)
🏢 Sandoz India
📍 India