Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.
We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.
For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.
What we offer:
Within the SSU team, and in collaboration with other regulatory managers and clinical trial project leaders:
– Compile, submit and follow up clinical trial opinion and authorization applications to ANSM and CPP (Comité de Protection des Personnes).
– Participate in meetings of the EC support team and project teams to coordinate CPP and ANSM activities.
– Report to global and local teams, and update support monitoring software.
Minimum Requirements :
– Extensive experience in a pharmaceutical laboratory preparing and submitting dossiers to the CPP and ANSM for interventional research,
– In-depth knowledge of the Dossier du Médicament Expérimental section for the ANSM dossier.
– Knowledge of CE regulations and corresponding systems (EUDRALINK, etc.),
– Team spirit, rigor, multi-project work.
– Fluent English
Position located in Paris Area