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Novartis Corporation (Malaysia) Sdn. Bhd. is seeking a Medical Manager to support the design, implementation and execution of Medical Affairs plans for the assigned Therapy Area.
You will provide scientific information and help design and organize clinical studies, while building educational dialogue with KOLs and regulatory stakeholders. You will ensure timely, high-quality responses to medical enquiries, contribute medical input to trials, support non-interventional studies, and coordinate
Job Description Summary In line with overall product strategy, the Medical Manager is responsible for supporting the design, implementation and execution of Medical Affairs plans for assigned Therapy Area, providing scientific information, helping design & organise clinical studies, building educational dialogue with KOLs and regulatory stakeholders
Ensure medical enquiries are responded to in a high quality, timely manner, and in accordance with applicable standards; establish standard response documents as appropriate, for frequently asked questions. Provide medical/scientific input into the development and execution of clinical trial or clinical research related activities, including initiation and oversight of clinical studies / clinical research within the respective therapeutic area. Support country strategy for Non Interventional studies/Investigator Initiated Trial activities. Coordinate review and approval of medical materials and locally developed promotional materials; ensure medical materials provided from global or region for stakeholder engagement and events are tailored to local needs and reviewed/approved per local/P3 guidelines. Ensure medical insights are provided to cross functional groups, including, but not restricted to: Pharmacovigilance, Regulatory affairs, Market Access, QA, Commercial teams, Brand team and others. Responsible for risk identification and assessment, mitigation planning as well as implementation and monitoring of appropriate internal controls within the area of responsibilities. Ensure robust medical governance processes & KPI are met for the department
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