The Export Compliance Specialist is responsible for ensuring that all international shipments of clinical support materials, including printed study materials and non-medical ancillary equipment (e.g., laboratory and medical equipment), are compliant with global trade regulations.
This role focuses on small-parcel and time-sensitive global logistics, supporting clinical trials by enabling compliant, on-time delivery of materials to investigator sites, depots, and partners worldwide. This position plays a critical role in export documentation accuracy, regulatory adherence, and cross-functional coordination with internal teams, clients, and logistics providers.
Job Functions and Responsibilities:
Export Compliance & Documentation
- Prepare, review, and process export documentation (commercial invoices, packing lists, shipping labels, EEI filings where applicable)
- Ensure compliance with US export regulations (EAR, OFAC, Census) and destination country import requirements
- Classify products using HTS/Schedule B codes and maintain proper documentation records
- Apply and interpret INCOTERMS 2020 to ensure correct shipment responsibilities and risk transfer
- Verify restricted party screening and embargo compliance for all shipments
Global Logistics Execution
- Coordinate small parcel international shipments through courier networks and specialized clinical logistics providers
- Manage shipments containing:
- Printed clinical trial materials
- Ancillary equipment (e.g., lab support devices, refrigeration units, diagnostic equipment)
- Ensure door-to-door shipment visibility, tracking milestones, and resolving delays proactively
- Support formal and informal customs clearance processes, including pre-alerts and entry preparation
Operational Support & Systems
- Process and release orders within ERP/Logistics systems
- Maintain shipment queues, resolve holds, and correct discrepancies in open shipment reports
- Utilize internal platforms and tools (ERP, shipment management systems, courier software)
- Support data integrity for Importer of Record (IOR) documentation and country-specific requirements
Cross-Functional Communication
- Partner with Project Managers, Clinical Supply Teams, and Distribution Associates to ensure shipment readiness and compliance
- Communicate with freight forwarders, small parcel carriers, and customs brokers to resolve shipment issues
- Guide internal teams and clients on export requirements and best practices
Continuous Improvements & Compliance
- Identify process improvement opportunities in export workflow and documentation accuracy
- Support audits, internal reviews, and quality initiatives related to global logistics and trade compliance
- Maintain working knowledge of evolving international trade regulations affecting clinical supply chains