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Country Approval Specialist
В офисеПолная занятостьRegulatory LawClinical ResearchPharmaceuticals and Biotechnology
Coordinate country-level regulatory and ethical submissions supporting clinical trial site activation in Israel. Prepare and review submission documents, advise internal teams on local requirements, and maintain accurate study records and timelines.
Обязанности
- Prepare, review, and coordinate local Ministry of Health, ethics committee, and other applicable regulatory submissions
- Provide local regulatory strategy guidance to internal clients under supervision
- Coordinate site start-up activities and submission timelines with internal and external stakeholders
- Act as a country-level contact for ethical and regulatory submission activities
- Support sites and study teams in achieving timely site approval and activation
- Coordinate local study start-up and feasibility activities
- Maintain trial status information in tracking databases
- Set up and maintain country study files in accordance with procedures and client requirements
- Maintain knowledge of company procedures, client directives, and applicable regulatory guidelines
- Support regulatory compliance review packages, patient documents, and site payment activities as required
Требования
- Bachelor’s degree or international equivalent
- At least 2 years of clinical research site start-up experience in a pharmaceutical company, CRO, or relevant industry vendor
- Knowledge of clinical study protocols and essential documents
- Knowledge of applicable national regulatory guidelines and ethics committee regulations
- Basic medical or therapeutic-area knowledge and medical terminology
- Proficiency in Microsoft Excel, Word, and PowerPoint
- Good English communication and grammar skills
Будет плюсом
- Experience with country-specific patient information sheets and informed consent forms
- Experience with regulatory compliance review packages
- Experience negotiating site grants and payment schedules
- Experience supporting clinical trial feasibility activities
Условия и преимущества
- Competitive salary
- Extensive health and well-being benefits
- Flexible working culture
- Work-life balance support
- Learning and development opportunities
- Collaborative international environment