摘要
In line with overall product strategy, the Medical Advisor is responsible for supporting the design, implementation and execution of Medical Affairs plans for CRM therapy area, providing scientific information, helping design & organise clinical studies, building educational dialogue with KOLs and regulatory stakeholders
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)
Minimum requirements
- Medical Doctor, PHD or Degree in Pharmacy
- English Clinical Research Phases; Medical Science and Disease Area Knowledge; Medical Education and Scientific Engagement; Third-Party Sponsored Trials Medical Governance
- Able to understand changing dynamics of Pharmaceutical industry
- Proficient and fluent in English (spoken and written), with good interpersonal and communication skills.
- Digital & Technology Savvy
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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Innovative Medicines
MY01 (FCRS = MY001) Novartis Corporation (Malaysia) Sdn. Bhd. (19710100054)
Research & Development
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