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 assigned 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)
Key performance indicators:
- Works within Ethics & Compliance policies -Achievement of annual targets for medical activities
Minimum Requirements:
Work Experience:
- Collaborating across boundaries.
- Operations Management and Execution.
- Project Management.
Skills:
- Building Construction.
- Clinical Practices.
- Clinical Research.
- Clinical Trials.
- Drug Development.
- Hazard Identification.
- Health Sciences.
- Immunology.
- Intensive Care UnIT (Icu).
- Internal Control.
- Internal Medicine.
- Job Description.
- Medical Information.
- Organization Skills.
- Patient Care.
- Stakeholder Engagement.
- Tcp/Ip Protocols.
- Utilization Management (Um).
Languages :
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Innovative Medicines
MY01 (FCRS = MY001) Novartis Corporation (Malaysia) Sdn. Bhd. (19710100054)
Research & Development
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