Medical Lead

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 and organise clinical studies, building educational dialogue with KOLs and regulatory stakeholders

About the Role

Major accountabilities:

• Support country medical affairs strategy in line with the global strategy, country insights and market conditions, & secure implementation of planned Medical Affairs activities within the designated therapy area(s).
• Coordinate scientific meeting, symposia, congresses, Continuous Medical Education (CME) and other medical / scientific exchange and engagement activities which could bring additional value to the relevant therapy area; develop strategic engagement plan(s) for country customer-facing medical activities and events, and ensure timely execution of planned medical affairs activities in an efficient and compliant way.
• 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)

• Works within Ethics and Compliance policies -Achievement of annual targets for medical activities

• Operations Management and Execution.
• Project Management.
• Collaborating across boundaries.

• Medical Governance.
• Third-Party Sponsored Trials.
• Medical Education and Scientific Engagement.
• Health Economics and Market Access.
• Non-Interventional Studies (NIS) / Epidemiology Studies.
• 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.

• English.