Medical Lead
3 months ago
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.
Your Key Responsibilities:
Your responsibilities include, but are 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.
Commitment to Diversity and Inclusion / EEO:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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