10 ott - Milano
Psi
Job Description
Join our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career.
Hybrid working arrangement in Milan area
Your role:
Support country-level regulatory activities for Italy under the EU Clinical Trials Regulation (CTR) Prepare and coordinate CTR Part II submission packages for Italy Communicate with regulatory authorities, project teams and vendors on regulatory-related matters Review translations of essential documents subject to clinical trial submission Track the regulatory project documentation flow Review documents to greenlight IP release to sites
Qualifications
Scientific University degree or an equivalent combination of education, training and experience Previous experience with CTR Part II submissions for Italy is mandatory Full working proficiency in English and Italian Proficiency in MS Office applications Detail-oriented Ability to learn, plan and work in a dynamic team environment Communication, collaboration, and problem-solving skills
10 ott - Spilimbergo
BiDoc
10 ott - Bronte
Work & Progress
10 ott - Emilia-Romagna
Archimede
10 ott - Torino
Jet HR