At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

　　Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

　　That’s our vision. We’re driven by it. And we need talented people who share it.

　　If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

　　Job Description

　　• Coordinate the process to allow import and export of clinical study supplies (may include, but not limited to, Investigational products (IP), non-IPs, medical device, laboratory kits and equipment): request, compile, complete and/or review necessary documentation, request import/export license approval from competent authorities as applicable; interact with couriers, brokers and customs authorities.

　　• Prepare and submit initial import/export license applications, amendments and/or renewals to competent authorities in accordance with protocol, pharmacy/laboratory manuals and/or study-specific requirements, as applicable

　　• Create and/or review pro forma/commercial invoices and any other relevant documentation for import and/or export, in accordance with local country requirements and client specifications, as applicable

　　• Review and request required changes to pro forma/commercial invoices or any other relevant documentation, to ensure accuracy and completeness; provide approval for shipments as applicable

　　• Liaise effectively with Clinical team CTM/PM/CRA to ensure country specific requirements are noticed and discussed prior to study related shipments see LCI

　　• Liaise effectively with customs authorities, depots, third party vendors including courier companies and brokers with regard to study shipments, custom clearance and delivery

　　• Coordinate study supply distribution to study sites (or authorized destinations) and keep project teams informed of shipment status and issues if any• Attend study team teleconferences/meetings in relation to logistic issues as needed

　　• Maintain granular tracking on study related shipments, remaining balance of approved quantity and import/export license validity, as applicable• Support document filing as per ICON SOPs and study requirements

　　• Be familiar with ICH GCP, relevant ICON SOPs, applicable country legislation and requirements with regard to import/export activities and provide country specific logistics expertise to project teams

　　• Contact the study sites and confirm that information regarding missing equipment provided during PSV is current; inform CTM of missing equipment for site (Israel)

　　• For equipment that will not be provided by the sponsor, support the site with local sourcing and follow up to confirm that equipment is in place before site activation (Israel)

　　• For existing equipment at site to make sure that calibration documentation available (Israel)

　　• Be the point of contact for internal/external audits in relation to logistics and supplies

　　• Work independently on tasks and assignments with minimal to no supervision

　　• Interact directly with the customer on questions of import/export processes

　　• Attend bid defenses if needed

　　• Provide trainings to junior staff and other departments as needed

　　• Have a basic knowledge of import/export processes in additional countries

　　• Engage in process improvement initiatives

　　• Support other study start up activities as assigned

　　• Travel (approximately 5%) domestic and/or international

　　Required:

　　3 years experience in pharmaceutical industry with at least 2 years experience in IMP /Clinical supply management.

　　Potential Specific Domains:

　　In-depth knowledge of local and global regulations and guidelines applicable to R&D IMP Management.

　　Excellent interpersonal, communication, and facilitation skills.

　　Must know Import/Export processes applied to IMP.

　　Knowledge of medical and drug devices.

　　Benefits of Working in ICON:

　　Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

　　At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

　　ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

　　If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know

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