Possession of a College/University degree or an equivalent combination of education, training, and experience; a life sciences degree is advantageous.A minimum of one year of experience in clinical trial submissions within the CRO or pharmaceutical industries in Israel is required.Demonstrated proficiency in both English and Hebrew.Proficient in MS Office applications and ‘Matarot’ software.A keen attention to detail and the ability to learn quickly in a dynamic team setting.Strong communication, collaboration, and problem-solving capabilities.*Please submit your CV in English.
About the job
Become a vital part of our esteemed team specializing in regulatory and ethical submissions for clinical studies. As a Country Approval Specialist, your primary focus will be on streamlining the initiation of research projects involving innovative medicinal products, while advancing in your professional journey.
This is an office-based role located in Ra'anana, Israel
Your responsibilities will include:
Preparing comprehensive clinical trial submission dossiers for Regulatory and Ethics Authorities.
Engaging with regulatory bodies, ethics committees, project teams, and vendors regarding regulatory matters.
Reviewing translations of essential documents required for clinical trial submissions.
Monitoring the regulatory project documentation flow to ensure compliance.
Assessing documents to authorize the release of Investigational Product to study sites.
Managing safety reporting responsibilities to relevant authorities.
Providing regulatory training and support to project teams.
Assisting with feasibility research and addressing business development inquiries.
About psicro
PSI is a premier Contract Research Organization with over 30 years of experience in the industry, striking an exceptional balance between stability and innovation for both clients and employees. Our commitment lies in delivering high-quality services punctually across a wide range of therapeutic areas.
This job posting is no longer active and is not accepting applications.
Possession of a College/University degree or an equivalent combination of education, training, and experience; a life sciences degree is advantageous.A minimum of one year of experience in clinical trial submissions within the CRO or pharmaceutical industries in Israel is required.Demonstrated proficiency in both English and Hebrew.Proficient in MS Office applications and ‘Matarot’ software.A keen attention to detail and the ability to learn quickly in a dynamic team setting.Strong communication, collaboration, and problem-solving capabilities.*Please submit your CV in English.
About the job
Become a vital part of our esteemed team specializing in regulatory and ethical submissions for clinical studies. As a Country Approval Specialist, your primary focus will be on streamlining the initiation of research projects involving innovative medicinal products, while advancing in your professional journey.
This is an office-based role located in Ra'anana, Israel
Your responsibilities will include:
Preparing comprehensive clinical trial submission dossiers for Regulatory and Ethics Authorities.
Engaging with regulatory bodies, ethics committees, project teams, and vendors regarding regulatory matters.
Reviewing translations of essential documents required for clinical trial submissions.
Monitoring the regulatory project documentation flow to ensure compliance.
Assessing documents to authorize the release of Investigational Product to study sites.
Managing safety reporting responsibilities to relevant authorities.
Providing regulatory training and support to project teams.
Assisting with feasibility research and addressing business development inquiries.
About psicro
PSI is a premier Contract Research Organization with over 30 years of experience in the industry, striking an exceptional balance between stability and innovation for both clients and employees. Our commitment lies in delivering high-quality services punctually across a wide range of therapeutic areas.
