Overview:
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 6,000 people across 40+ countries.
Responsibilities:
* Manage and maintain Import & Export activities and vendors (including brokers) for a clinical trial project in a country and/or region according to the scope contracted and timelines agreed; This includes frequent communication with exporters, brokers, customs, couriers and regulatory/clinical teams;
* Obtain the necessary information from client and vendors/exporters that supports the Import License application and approval process;
* Support the Regulatory Submission team by reviewing the initial CTA application to ensure appropriate study supplies are listed and complies with Import & Export local practices & regulation;
* Provide advice and guidance to internal and external team members to ensure compliance with applicable regulations and requirements on Import & Export processes in the region;
* Review pertinent regulations and guidance, including updates, to develop proactive solutions to Import & Export issues and challenges in the region; and
* Utilize and assist in maintaining the Internal tracking system and/or other department trackers with Import & Export documentation, submission, approval and expiration dates.
Qualifications:
***Please submit CV in English***
* Bachelor's degree required, preferably in a business or life science field;
* Fluent written and verbal English;
* Demonstrate time management and professional oral and written communication skills; and
* Demonstrated ability to think critically, independently, and exercise good judgement.
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