Regulatory Affairs Platform Coordinator

Vor 2 Tagen

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.

The SCTO has set up a national network of thematic expertise platforms for clinical research specialists to share experience and promote excellence in professional standards and quality in clinical studies (Fact sheet). The State Secretariat for Education Research and Innovation (SERI) funds the platform network as part of the SCTO Research Infrastructure of National importance through the Federal Act on the Promotion of Research and Innovation (RIPA art. 15). Each Clinical Trial Unit member of the SCTO network is responsible for the coordination of one National platform (SCTO platforms website).

The CRC is in charge of coordinating the Regulatory affairs platform, hence, this open position. Institutionally, the CRC is a key element of the Integrative Centre for Clinical research at CHUV. Through its collaboration with the Faculty of Biology and Medicine at the University of Lausanne (UNIL) and the EPFL, the CHUV plays a lead role in the fields of generating evidence for medical care, supporting medical research and providing related training.

In this context, the CHUV is looking for a clinical research specialist to fill the **Regulatory Affairs Platform Coordinator role.**

**Mission**:

- You will be coordinating the National Regulatory Affairs (RA) platform of the SCTO (Swiss Clinical Trial Organization)
- You will be overarching the elaboration of the "Regulatory Affairs Watch" (RAW) the SCTO regulatory affairs platform newsletter
- You will endorse the role of the SCTO national point of contact for regulatory affairs in clinical research
- You will contribute to the reinforcement of the regulatory affairs group expertise of the CRC
- You will participate in researching mandates and supporting tasks regarding the quality management system at the CRC.

**Profil**:

- Doctorate level in either medical, pharmaceutical or biological sciences. A mix of them (MD-PhD or Pharm D-PhD) ensuring a larger background would be preferred
- Training in clinical research (Certificate of advanced studies, or better, Master in methodology/trial management or equivalent)
- Practical experience in clinical research conduct, with a particular interest in the regulatory field, experience in interactions with competent authorities, ethic committees, and other stakeholders is essential. Previous exposure to pharmaceutical industry standards would be a plus
- Experience in project management, expertise networks, matrix organizations cross-functional teams and opinion leaders management Experience in complex multicenter projects management encompassing stakeholders with various backgrounds would be a plus
- Connections with both academic and industry-driven clinical research are welcome
- Excellent knowledge of the regulatory environment of clinical research, including international standards as GCP, ISO and Swiss Federal Act on Human Research and its ordinances. Knowledge of the European regulation on clinical research is a plus
- Full professional proficiency in English. Mastering additional national Swiss languages is highly welcomed
- Particular attention will be given to soft skills such as smooth diplomatic leadership and 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:

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