Job Description
-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 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.
- Medical Information.
- Organization Skills.
- Patient Care.
- Stakeholder Engagement.
- Tcp/Ip Protocols.
- Utilization Management (Um).
Languages :
Skills Desired
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)
