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
- 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
PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
Base salary range: €36,000 – €46,000 gross annual salary.
Actual compensation: The salary offered within the stated range will depend on objective, job-related criteria, including demonstrated competencies, qualifications, and skills relevant to the position.
Additional compensation: bonus, incentive plans, and other benefits may apply.
Please submit your CV in English.