Medical Lead Specialist
5 days ago
About the Role
We are seeking a highly skilled Medical Lead to support our Medical Affairs plans for assigned Therapy Areas.
As a Medical Lead, you will provide scientific information, help design and organise clinical studies, build educational dialogue with KOLs and regulatory stakeholders, and ensure medical enquiries are responded to in a high quality, timely manner.
You will also provide medical/scientific input into the development and execution of clinical trial or clinical research related activities, including initiation and oversight of clinical studies within the respective therapeutic area.
Main Responsibilities:
- Ensure medical enquiries are responded to in a high quality, timely manner, and in accordance with applicable standards;
- Provide medical/scientific input into the development and execution of clinical trial or clinical research related activities;
- 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 insights are provided to cross functional groups;
- 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.
Key Performance Indicators:
- Works within Ethics & Compliance policies;
- Achievement of annual targets for medical activities;
- Minimum of 3 years of experience in medical affairs;
- Proven experience in the local market;
- Demonstrated expertise in pre-launch planning and execution;
- Business proficiency in English;
- Advanced degree (PhD or MD) in a relevant field is preferred;
- Experience in renal therapy or related areas is preferred.
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