Medical Lead Specialist
1 month ago
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 areas, providing scientific information, helping design & organize clinical studies, building informative dialogue with key opinion leaders and regulatory customers.
Your Key Responsibilities:- Ensure high-quality, timely responses to medical inquiries, 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 trials 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 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).
- Minimum 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.
Estimated Salary Range: €80,000 - €110,000 per year
Company OverviewAdvanced Accelerator Applications (Italy) - S.p.A. is a leading company in the field of nuclear medicine. Our innovative solutions aim to improve patient care and outcomes.
Job DescriptionThis role is part of our medical affairs team, responsible for supporting the design, implementation and execution of medical affairs plans for assigned therapy areas. The successful candidate will work closely with cross-functional teams to provide scientific information, help design & organize clinical studies, build informative dialogue with key opinion leaders and regulatory customers.
Required Skills and QualificationsTo be successful in this role, you will need:
- A minimum of 3 years of experience in medical affairs from the pharma industry.
- A life sciences degree.
- Proficient Danish and English, both written and spoken.
- Strong project management skills.
- Excellent stakeholder engagement skills.
We offer a competitive salary range of €80,000 - €110,000 per year, as well as additional benefits such as health insurance, retirement plan and paid time off.
Commitment to Diversity and Inclusion / EEONovartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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