Scto National Regulatory Affairs Platform

vor 1 Woche

Lausanne, Schweiz Centre hospitalier universitaire vaudois Vollzeit

**Contexte**:
The Lausanne University Hospital (CHUV) is one of five Swiss university hospitals. Through its collaboration with the Faculty of Biology and Medicine of the University of Lausanne and the EPFL, CHUV plays a leading role in the areas of medical care, medical research and training.

Member of the network of the Swiss Clinical Trial Organization (SCTO), the Clinical Research Center (CRC) was created jointly by the CHUV and the Faculty of Biology and Medicine of the UNIL. Its objective is to provide clinicians and researchers with methodological, logístical and educational support for carrying out clinical studies.

Structure recognized and funded by the State Secretariat for Education, Research and Innovation (SERI), the CRC has been entrusted by the SCTO with the development of a national regulatory affairs platform in clinical research.

In this context, the CHUV is looking for a **SCTO National Regulatory Affairs Platform Coordinator at 80% - 100%**

**Mission**:

- You will coordinate the activities and projects of the National Regulatory Affairs (RA) platform of the Swiss Clinical Trial Organisation (SCTO)
- You will coordinate the project "Regulatory Affairs Watch" (RAW) newsletter driven by the RA platform
- You will endorse the role of SCTO national point of contact for regulatory affairs in clinical research
- You will reinforce the expertise of the regulatory affairs group of the CRC, participate in research mandates and support tasks as well as in the quality management system of the CRC
- You will support the clinical research training of researchers as a regulatory affairs specialist.

**Profil**:

- You have a degree in medicine, biology or pharmacy,
- You have received training in Good Clinical Practice (GCP) and a training in clinical research type CAS, DAS or MAS
- You have a professional experience of at least 5 years in conducting clinical research, with a particular interest in the regulatory field, and in project management
- You have excellent knowledge of the clinical research regulatory environment, and an experience in managing complex multicentric projects
- You are fluent in French and English (another national language is a plus)
- You demonstrate leadership and diplomacy, and you have developed interpersonal communication skills.

**Nous offrons**:
**To become an employee of the world-famous University Hospital Center from the Canton of Vaud is an assurance of**:

- First-rate social benefits such as a Paternity Leave of 20 days and a Maternity Leave of 4 months (there is also the possibility to obtain a complementary breastfeeding leave of 1 month)
- A 13th salary and 25 days of vacations per year
- A right to at least three days of training per year, by accessing a wide offer of courses not only from the CHUV Training Center but also from external providers
- Possibility to access one of the 500 furnished apartments offered in the surrounding neighborhoods in case of relocation in Switzerland
- Discounts proposed on social and cultural events, goodies and other services, thanks to the “H-Oxygène” association
- Signing up to our Mobility Plan and benefit from different advantages (discounts on public transportation, promotion of “Mobility” car fleet and discounts on electric bikes)
- Being able to enjoy our high-quality corporate restaurants, located in every hospital building, with employees’ discount

Contact person in case of questions about this role:
Dr Aurélie Fayet, Head CTU-CRC, 079 556 45 86

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