Summary
Location: Copenhagen, Hybrid.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 & organise 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).
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Essential Requirements:
- 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.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
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.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Division
International
Business Unit
Innovative Medicines
Location
Denmark
Site
Copenhagen
Company / Legal Entity
DK06 (FCRS = DK006) Novartis Healthcare A/S
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No