Job Description

Summary -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 :

• English.

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, , Medical Information, Organization Skills, Patient Care, Stakeholder Engagement, Tcp/Ip Protocols, Utilization Management (Um)

Novartis