- Planning and conducting clinical studies in accordance with ISO 14155 for the purpose of obtaining and maintaining international product authorizations (incl. PMCF)
- Preparation of study plans and reports as well as scientific publications in medical journals
- Coordinating the collaboration of international teams in the implementation of clinical studies and observational studies
- Collaboration in the preparation of relevant documents in the context of international authorization procedures (EU-MDR, FDA, etc.)
- Preparation of scientific presentations and product information
- Maintaining contacts with opinion leaders, participation in congresses and symposia
- Collaboration and support with product training courses worldwide, in particular for the fields of interventional cardiology/radiology and vascular surgery
- University degree in a life-sciences field / Doctorate with a scientific focus desirable
- Clinical / regulatory experience in the medical technology (or pharmaceutical) industry, preferably in vascular medicine
- Experience in conducting clinical evaluations and / or clinical studies
- Excellent analytical skills as well as good communication and presentation skills
- Business fluent in German and English, ideally basic knowledge of another language (French, Spanish)
- Willingness to travel, professional experience abroad an advantage
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Manager Scientific Affairs - Berlin, Deutschland - SciPro
Beschreibung
Manager Scientific Affairs (m/f/x) | Berlin
In this position you will be mainly responsible for planning and conducting clinical studies in accordance with ISO 14155 for obtaining and maintaining international product authorizations. You will be preparing study plans and reports, be part of the preparation of relevant documents in the context of international authorization procedures (MDR, FDA etc) and prepare scientific presentations and product information.
What will your tasks as "Manager Scientific Affairs (m/f/x)" be?
Your requirements as "Manager Scientific Affairs (m/f/x)"?
Information about our client:
Our client is one of the leading medical technology companies in the world. They have been active in the market for more than 180 years with more than people working there worldwide. They are present in more than 50 countries and their huge portfolio holds around 3000+ products. They have a strong focus on R&D and invest around 200+million euros into their pipeline every year.
My contact details:
Email:
Tel: / direct dial)
I look forward to your application