Company Description

PSI is a leading Contract Research Organization with more than 25 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.

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.

Office-based role in Ra'anana , Israel

You will:

Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities

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

QualificationsCollege/University degree or an equivalent combination of education, training and experience. Life science degree is a plus

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

Additional Information

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.