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
Requirements
- College/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 `Matarotโ 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
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PSI CRO
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
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