Lead, Specialty Medical Science

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:

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

Skills:

• 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.

Languages :

• Japanese
• English