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Medical Affairs Development Head
hace 3 meses
.Almost 1 billion That's how many lives our product touches globally.We aspire to get Novartis medicines in the hands and homes of patients by delivering a Triple Win: A Win for Patients; A Win for Healthcare Systems, and A Win for Novartis.The Medical Affairs Development Head is a key end-to-end role that will involve the development and effective execution of local evidence generation to ensure that the Medical Affairs strategies and TA's investigational objectives are met. Additionally, provide direction and supervision to the local clinical operations team within MedEx & Gov. Dpt., Country Medical Head, and TMO. Furthermore, this role will be responsible for the planning, management, and delivery of local clinical trials at the country level within MedEx & Gover. Department in collaboration with local and global stakeholders (including Regional/Global Clinical and Trial Operations Management teams), ensuring effective execution and completion of trials with high quality, and ensuring full alignment with the strategic needs of the Medical Affairs Unit at the CPO level.Your key responsibilities:Your responsibilities include, but are not limited to:Head and coordinator of the contracting of external associates (CSM/Clinical Study Manager), follow-up with CRO to guarantee the delivery, implementation, and compliance with the established procedures in accordance with GCP, GPP, ICH, and local regulations, ensuring the collection of high-quality data and ensuring all deadlines and budget targets are properly fulfilled.Coordination and consistency of cross-therapy area (TA) studies within the medical affairs department. Define project tasks and resource requirements.Act as a point of contact for the medical local team, initiating, approving, and monitoring NVS sponsored Research Collaborations and IITs studies. Bring medical and technical expertise to the medical affairs team, relevant brand teams, and other internal business partners including regulatory and strategic development.Manage development trial monitoring issue identification, escalation, and resolution aligned with the MedEx & Gover. Head, Country Medical Head, TMO Head and by partnering with Development/Country QA, as applicable.Identify study-related regulatory and quality issues and manage complaints and any subsequent legal actions.Drive excellence of medical affairs operations and processes including quality control and assurance to ensure audit/inspection readiness.Assure compliance with SOPs and local regulations, checking that all processes are correctly documented and updated. Deliver quality data and compliance to quality standards.Coordinate the hiring of external associates and follow up with the CROs. Review with CRO the tracks performance through key performance indicators to assure end-to-end delivery of key milestones.Partner with the Country Medical Development Unit to create competitive advantages allowing for an adequate footprint of trials and patients
