Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Ctry Approval Assoc (Clinical Import Customs, 수입표준통관)

Participates in the management and preparation, review and coordination of Import permit submissions in line with global submission strategy.

Responsibilities

Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.Request study specific Proforma Invoice template to study team for the information to apply for the initial Import License (IL), co-review the content of proforma invoice template with Import/Export Coordinator (IEC), verify the IOR information and other information is correct on proforma invoice and IL application form against product outer packaging/label/pack list for consistency.  Checks with RA whether the study related ancillary supplies requires an import license including assessment of quantity.Submits not only initial IL application to RFDS/KPTA/KMDIA but also amendment and/or renewal IL application to RFDS/KPTA/KMDIA for ongoing studies, if requires.Submits the required documents to obtain permission for Electronic Device/Electromagnetic wave-generating device/Chemical materials, if requires.File the IL in study files (e.g. eTMF) as applicable.Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

Requirements

Have experience with importing clinical supplies (Investigational Product, Non-Investigational Product, Ancillary Supplies, Medical Devices, Electronic Devices & Laboratory Supplies etc.) and knowledge of import requirementsBachelor's degree or above