Trade Compliance Specialist

Trade Compliance Specialist

The Trade Compliance Specialist supports all customs, logistics, and international trade activities for pharmaceutical specialty products while providing administrative support for shipping operations. In this role, you manage agency clearances with organizations such as USDA, FDA, and EPA, coordinating closely with corporate customs brokers to ensure compliant and timely delivery of imported materials. You define and implement continuous improvement initiatives for trade compliance, including metrics, education, training, and process enhancements, contributing to the overall success of the organization. The position offers significant latitude for independent action and requires sound judgment in navigating complex regulatory and operational challenges.

Responsibilities

• Serve as the North America subject matter expert for import and export compliance, ensuring activities align with company policies and global market requirements.
• Prepare, organize, and maintain import and export documentation for clinical drug products and specialty instruments, ensuring accuracy and regulatory compliance.
• Resolve clearance issues for shipments entering or leaving the United States, acting as the subject matter expert for all required import and export documents, including customs declarations, pro forma invoices, TSCA chemical statements, and certificates.
• Partner with project managers to coordinate domestic and international drug product shipments based on internal and external client needs.
• Collaborate with corporate headquarters to develop efficient corporate programs that support the global clearance of clinical and research materials.
• Act as author, reviewer, or signatory on shipping and customs-related business documents, ensuring proper documentation and classification.
• Document and maintain Harmonized Tariff Schedule (HTS) codes for scientific and pharmaceutical-related items to support accurate classification and compliance.
• Critically generate and review import documentation to identify and address potential compliance issues.
• Manage and coordinate the work of external service providers, including customs brokers, shipping carriers, forwarders, consultants, and relevant government agencies.
• Conduct research on import, export, and trade compliance fundamentals to support decision-making and continuous improvement.
• Use Microsoft applications such as Word, Excel, PowerPoint, Access, Visio, and Project to support project work, documentation, and management reporting.
• Communicate effectively with U.S. regulatory agencies involved in import and export activities to facilitate compliant and efficient shipment clearance.
• Work independently with minimal supervision, demonstrating strong organizational skills and high attention to detail.
• Contribute to education and training initiatives related to trade compliance, supporting process improvements and the development of compliance metrics.

Essential Skills

• Bachelors degree from an accredited college or university, preferably in Business, Logistics, Trade Compliance, Customs, Pharmaceutical studies, or a related field, or a combination of relevant education and experience.
• A minimum of 5 years of experience working with customs brokers, shipping carriers, forwarders, consultants, or government agencies in trade compliance-related matters.
• Demonstrated ability to critically generate and review import documentation for accuracy and regulatory compliance.
• Strong technical skills and research capabilities in import, export, and trade compliance fundamentals.
• Experience managing the work of external service providers such as brokers, carriers, and consultants.
• Proficiency with Microsoft applications, including Word, Excel, PowerPoint, Access, Visio, and Project, to support project work and reporting.
• Comfort navigating regulatory guidance related to pharmaceutical products and applying it to daily operations.
• Ability to communicate effectively with U.S. regulatory agencies involved in import and export activities.
• Strong organizational skills with high attention to detail.
• Well-developed interpersonal skills to collaborate with internal teams and external partners.
• Capability and desire to work independently with minimal supervision.
• Experience with ERP systems; SAP experience is particularly valuable.
• Experience in trade compliance, customs, logistics, shipping carriers, freight, and brokers.
• Ability to work with shipping carriers and logistics providers to coordinate compliant shipments.

Additional Skills & Qualifications

• Experience in the pharmaceutical industry is preferred, though candidates from other industries with strong trade compliance backgrounds are welcome.
• Knowledge of automated systems such as SAP, ShipERP, and Process Weaver is a plus.
• Project management experience or skills are advantageous.
• Professional certifications such as CPA, MBA, broker license, or other relevant credentials are considered an asset.
• Experience using Visio and Microsoft Project to support process mapping and project tracking.
• Familiarity with HTS code classification for scientific and pharmaceutical-related items.
• Experience with logistics coordination, freight management, and working with customs brokers and shipping carriers.
• Ability to contribute to continuous improvement initiatives in trade compliance, including metrics, education, and training.

Work Environment

This position is based in Gaithersburg, MD and operates primarily during standard business hours, typically 8:00 a.m. to 5:00 p.m. The role follows a hybrid work model, with an expectation of working onsite three days per week and remotely two days per week once fully trained. During the initial temporary assignment and training period, the role may require being onsite 100% of the time before transitioning to a 50% onsite and 50% remote schedule. The environment involves close collaboration with customs brokers, shipping carriers, logistics providers, and regulatory agencies, as well as regular use of ERP systems (such as SAP), automated shipping tools (such as ShipERP and Process Weaver), and Microsoft Office applications. The work setting is professional and detail-oriented, with a focus on accuracy, compliance, and timely shipment of clinical and pharmaceutical products. Strong performance in this temporary role may lead to consideration for a future permanent position if additional headcount is approved.

Job Type & Location

This is a Contract position based out of Gaithersburg, MD.

Pay and Benefits

The pay range for this position is $36.00 - $39.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Application Deadline

This position is anticipated to close on Nov 25, 2026.

Workplace Type

This is a hybrid position in Gaithersburg, MD.