Summary

総合的な製品戦略に沿って、メディカルアドバイザーは、割り当てられた治療領域の戦術設計、実施、実行を支援し、科学的情報を提供し、臨床研究の設計と組織化を支援し、KOLsや規制関係者との教育対話を構築する事で、患者および臨床現場にとって望ましい関係者の行動変容を促す事に貢献する責任を有します。

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)

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

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

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

• Japanese
• English