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.
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.
Office-based role in Ra'anana , Israel
You will:
Prepare clinical trial submission dossiers for Regulatory Authorities and Ethics Committees
Communicate with regulatory authorities, ethics committees, 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
Manage safety reporting to authorities
Deliver regulatory training to project teams
Assist with feasibility research and business development requests
Prior experience of at least one year with clinical trial submissions in Israel within the CRO or Pharmaceutical industries
Full working proficiency in English and Hebrew
Proficiency in MS Office applications and `Matarot’ software
Detail-oriented
Ability to learn, plan and work in a dynamic team environment
Communication, collaboration, and problem-solving skills
*Please send your CV in English
We offer:
Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas.
PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines.
PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world.
PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees.
http://www.psi-cro.com
