Summary
About the Role
Major accountabilities:
- 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)
Key performance indicators:
- Works within Ethics & Compliance policies -Achievement of annual targets for medical activities
Minimum Requirements:
Work Experience:
- Project Management.
- Operations Management and Execution.
- Collaborating across boundaries.
Skills:
- Medical Governance.
- Third-Party Sponsored Trials.
- Non-Interventional Studies (NIS) / Epidemiology Studies.
- Medical Education and Scientific Engagement.
- Health Economics and Market Access.
- Medical Science and Disease Area Knowledge.
- STEAM - Applied Science, Technology, Engineering, Arts, Math.
- Clinical Trial Set-up, Management & Conduct.
- Clinical Trial Design, Data & Reporting.
- Preclinical Safety.
- Medical Safety.
Languages :
- Japanese
- English
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
利便性と合理的配慮
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