Clinical Trials Manager
4 days ago
Job Description
We are seeking an experienced Medical Lead to join our team at Novartis. The successful candidate will have a strong background in Medical Affairs and will be responsible for ensuring medical enquiries are responded to in a high-quality, timely manner and in accordance with applicable standards.
Key Responsibilities
- 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.
- To 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.
- To support country strategy for Non-Interventional Studies/Investigator-Initiated Trial activities.
- To 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.
- To 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.
- To be responsible for risk identification and assessment, mitigation planning as well as implementation and monitoring of appropriate internal controls within the area of responsibilities.
- To report technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours of receipt - Distribution of marketing samples (where applicable).
Requirements
- Minimum 3 years of experience in Medical Affairs from the Pharma industry.
- Life Sciences Degree.
- Proficient Danish and English, both written and spoken.
- Project Management.
- Stakeholder Engagement.
Benefits
At Novartis, we offer a competitive salary and benefits package, including opportunities for professional growth and development.
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