Summary

Location: Copenhagen, Hybrid. (40 - 50% field)

In line with overall product strategy, the Medical Lead is responsible for supporting the design, implementation and execution of Medical Affairs plans for assigned Therapy Area, providing scientific information, helping design & organize clinical studies, building informative dialogue with KOLs and regulatory customers.

About the Role

Your Key Responsibilities:
Your responsibilities include, but not limited to:

• 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).

• Min. 3 years of experience in Medical Affairs from the Pharma industry.
• Education: Life Sciences Degree.
• Proficient Danish and English, both written and spoken.
• Project Management.
• Stakeholder Engagement.