Export Compliance Specialist

Description

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

Requirements

Education & Experience

• Associate's degree or equivalent experience required; Bachelor's degree preferred
• 2-4 years of experience in:
• International logistics
• Export compliance
• Small parcel shipping operations (preferred)

Technical Skills

• Familiarity with:
• Export regulations (EAR, OFAC, Census requirements)
• HTS/Schedule B classification
• INCOTERMS 2020
• Experience with ERP Systems and logistics/shipping platforms
• Proficiency in Microsoft Office (Excel, Outlook, Word)

Core Competencies

• Strong attention to detail and accuracy in documentation
• Ability to manage multiple high-priority, time-sensitive shipments
• Excellent problem-solving and critical-thinking skills
• Effective communication skills across internal and external stakeholders
• Ability to work independently in a fast-paced, deadline-driven environment
• Customer-focused mindset with strong follow-up discipline

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Fast-paced logistics and operations environment supports global clinical trial timelines
• Regular coordination across multiple time zones
• Moderate noise level consistent with office or warehouse support setting
• Occasional lifting (up to 50lbs) and interaction with packaged shipment materials
• Able to move a 500 lbs. pallet of goods with a pallet jack

Key Success Factors:

• Zero compliance violations or documentation errors impacting customs clearance
• On-time delivery performance for international shipments
• Strong collaboration with project and logistics teams
• Continuous improvement mindset in export processes and shipments
• Responsibility to adhere to the Imperial Quality Policy Statement