Job Type: 6 months contract to hire
• The Import/Export Specialist is responsible for the creation and implementation of export and import compliance policies and procedures for PDS. The position emphasizes resolving import/export compliance issues that may arise (during clinical study conduct), and includes interaction with legal counsel, and as necessary, government officials. A component of the position is analyzing and interpreting US and foreign countries import and export regulations.
• Create and implement export and import compliance policies and procedures for PDS regarding Clinical Trial Material (CTM) and raw material shipments
• Manage daily PDS import and export transactions ensuring compliance to all US Government Laws and Regulations. This includes US Customs Border and Protection, USDA, FDA, Public Health, Bureau of Industry and Security, DEA, FAA and possible other government agencies. Prepare formal responses for questions specific to imports or exports.
• Create 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
• Coordinate all international product data for development compounds: Country of Origin, Tariff Code/Schedule B, Export Commerce Control Number (ECCN), FDA product codes, NDA’s, 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 products. Create SOP’s for entire clinical supply chain process. Conduct annual performance assessments.
• Review PDS contracts and task orders to ensure international distribution pathways are aligned with the import/export regulations and the business needs
• Conduct post import audits ensuring transactions comply to US import regulations. If incorrect, provide instructions for entry corrections.
• Serve as a subject matter expert on internal committees.
• Assist in CTM budget preparation and control activities by identifying customs duties and taxes
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
• Minimum 4 years experience in R&D material management/project planning/ clinical supplies including 2 years experience in importing and exporting in pharmaceutical industry
• Bachelors Degree required, preferably in Business, Science or Law
• Strong working knowledge and understanding of the US Customs and Border Protection (CBP) regulations
• 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 and requirements for qualification
• Understanding of Automated Export System
• Computer database and spreadsheet experience
• Global Logistics experience
• Export Compliance Officer certification
• Strong written and verbal communication skills
• Strong general business and business application knowledge
• Excellent training, listening, diagramming and documentation skills
• Promotes a spirit of cooperation, trust and respect within the team and with others
• Demonstrated ability to focus on project work and efficiently bring projects to completion
• Demonstrates independent troubleshooting and problem solving.
• Demonstrate problem solving and decision making abilities
• Attention to details and strong analytical skills
• Leadership skills – ability to lead and train cross-functional project teams
• Strong ability to influence others and interpret government regulations
• Requires aptitude and potential to learn import and export regulations