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.
Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
Qualifications
At least 3 years of medical affairs experience in pharmaceutical industry
Proficiency on meeting medical experts and obtaining valuable insight
Experience of leading the launch process with leadership by accepting the difficulties involved in preparing to launch a drug with a new mechanism for kidney disease as a challenging and meaningful process.
Understanding and interpreting the pathophysiology, clinical design, and results of rare kidney diseases, active data sharing and scientific discussion.
Cross-functional collaboration and project leading leading in launching new products
