Website Lenox Executive Search
6+ contract role with potential to extend. Role will require 2-3 days/week onsite with the remaining days remote.
Lenox Executive Search is seeking an experienced Import/Export Specialist to fill an 6++ month contractual role with a global pharmaceutical company in Cambridge, MA. Minimum (4 years) experience in R&D material management/project planning/clinical supplies including (2 years) experience in importing and exporting in pharmaceutical industry. Must have expert knowledge of Title 19 Code of Federal Regulations (CFR) and Harmonized Tariff Schedule (HTS) of the United States.
REQUIREMENTS of the Immport/Export Specialist:
- Minimum (4 years) experience in R&D material management/project planning/clinical supplies including (2 years) experience in importing and exporting in pharmaceutical industry
- Bachelor’s Degree required, preferably in Business, Science or Law
- Expert knowledge of Title 19 Code of Federal Regulations (CFR) and Harmonized Tariff Schedule (HTS) of the United States
- Proven knowledge of the Export Administration Regulations (EAR)
- Familiar with Customs-Trade Partnership Against Terrorism (C-TPAT) and Importer Self-Assessment (ISA) programs
- Understanding of Automated Export System (AES)
- Computer database and spreadsheet experience
- Global Logistics experience
- Certified U.S. Export Compliance Officer preferred
- Licensed Customs Broker License preferred
The Import/Export Specialist is responsible for the preparation and coordination of export and import shipping documentation as well as adhering to compliance policies and procedures for the Company’s Research and Development organizations. The position emphasizes managing Import/Export transaction requests, assisting management in the resolution of issues that may arise (during the shipments of clinical studies or movement of research materials), and includes interaction with customs brokers, freight forwarders and transportation service providers, and as necessary, with government officials from Customs, FDA, USDA, Fish and Wildlife Service and other participating government agencies.
- Assist in the creation and adherence of export and import compliance policies and procedures for the organization regarding Clinical Trial Material (CTM) and raw material shipments.
- Manage daily import and export transactions ensuring compliance to all US Government Laws and Regulations. This includes US Customs and Border Protection, USDA, FDA, Fish Wildlife, Public Health, Bureau of Industry and Security, DEA, FAA and possible other government agencies. This includes preparing formal responses for questions specific to imports or exports.
- Adhere to country specific standard operating procedures for importing/exporting clinical trial material and raw materials, including logistics, customs clearance and delivery cycle times.
- Continually track and maintain changes to regulations and define strategies to avoid potential conflicts.
- Liaise with in-country coordinators/CRO’s to establish standard import and export requirements for clinical trials, including export license determination.
- Help to maintain all international product data for development compounds: Country of Origin, Harmonized Tariff Codes, Export Commerce Control Number (ECCN), PGA Licenses & Permits, FDA product codes, IND’s for raw materials, chemical intermediates, and finished goods.
- Screen export orders for compliance with US Government denied party listings
- Verify shipment documentation of development compounds for proper valuation, classification, country of origin, and record retention.
- Instruct customs brokers and freight forwarders on how to handle the import/export transaction. Conduct post-entry review audits ensuring transactions comply with US import regulations. If incorrect, provide instructions for entry corrections. Help conduct TSP performance assessments.
- Review contracts and task orders to ensure international distribution pathways are aligned with the import/export regulations and the business needs.
- Assist in CTM budget preparation and control activities by identifying customs duties and taxes.