CTA Specialist
il y a 4 semaines
We are looking for an CTA Specialist to take care of our existing projects which would include the following responsibilities:
Responsibility:
Operational Activity:
Preparation and submission of CTA in EU and outside of EU from initial CTA preparation until notification of results
Review of documents (clinical study protocol, Informed consent form, …)
Capacity to provide the technical/practical regulatory expertise on the documents and on submission strategy
Coordinator Back-up
Required education:
Scientific background
Required experience :
5 to 10 years
Required languages:
French if possible
Required technical skills:
Good overview of Clinical Trials environment
Skills of Clinical Trials regulation
CTA management through CTIS / Transition management
Experience in coordination of team
Word/excel/powerpoint
Meeting management
Additional experience and/or skills:
eTMF : Veeva
Force of proposal, good analysis of situation, proactivity
Good relationship
A plus if skills for the following countries: Japan, China, US, Canada
- Capacity to manage multiple activities in same time
-
Regulatory Affairs Specialist 365
il y a 4 semaines
Paris, France ProductLife Group Temps pleinAbout the job To maintain ongoing exciting projects, we are urgently looking for a Regulatory Affairs Specialist to join our teams in France. About us Group 10 Responsibilities Preparation of registration files and answers to questions from the authorities Preparation of clinical study authorization request files Preparation of...
-
Technicien Frigoriste en itinérance
il y a 4 semaines
Paris, France GROUPE CONNECTT Temps pleinÀ propos de nousConnectt recherche pour un de ses clients un Technicien Frigoriste H/F en itinérance sur Paris et IDF.Nous sommes spécialistes de l'intérim sur 7 secteurs d'activité : - Le BTP (Second œuvre, gros œuvre et Bureau d'études) - L'Informatique - L'Industrie - Le Médical - L'Hôtellerie et la Restauration - Le...
