At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Organization & Position Overview
Clinical Supply and Delivery (CSD) provide the strategic planning, supply, and trial support services required to execute clinical trials globally across business units and development phases. Within Product Research and Development, CSD partners cross-functionally to influence trial design and deliver operational solutions that enable asset strategies across the portfolio.
Lilly Research Laboratories Trade Compliance and Import-Export Services (LRL TCIES) is part of CSD and supports the end-to-end drug development lifecycle by ensuring U.S. import and export activities comply with U.S. Customs and Border Protection (CBP) and key Partner Government Agencies (PGAs), principally the Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA), Environmental Protection Agency (EPA), and U.S. Fish and Wildlife Service (USFWS).
The Associate Director, TCIES & Foreign-Trade Zone (FTZ) Operations, LRL reports to the Senior Director – LRL Trade Compliance and helps develop and execute strategies that enable compliant, efficient, and scalable global clinical supply operations. The role supports expanded TCIES scope, including activation of the Medicine Foundry Foreign-Trade Zone, growth in Greenwood Innovation Center – Global Supply Logistics Solutions (GSLS) trade compliance needs, integration of trade compliance into the Enterprise Control Tower, and scalable support for Lilly acquisitions.
As a subject matter expert in Foreign-Trade Zone compliance, U.S. import/export operations, and trade compliance governance, this role provides day-to-day guidance and strengthens audit-ready execution across TCIES. The role bridges TCIES operations and broader governance and coordinates with clinical development, logistics, regulatory affairs, U.S. Import Export Compliance (USIEC), external suppliers, and global affiliates. Supervisory responsibilities may be assigned as organizational needs evolve.
Primary Responsibilities
Foreign-Trade Zone (FTZ) Operations & Regulatory Compliance (Medicine Foundry FTZ)
- Serve as the TCIES liaison for the Medicine Foundry FTZ; ensure import/export compliance with CBP, FDA, and other PGA requirements.
- Develop and maintain FTZ protocols (admissions, inventory controls, manufacturing determinations, privileged foreign and zone-restricted status elections, and weekly entry documentation) in coordination with U.S. Import Export Compliance (USIEC).
- Monitor FTZ regulatory changes; assess impacts, implement updates, and maintain audit readiness with the Senior Director – LRL Trade Compliance and USIEC.
- Advise on duty-deferral, duty-elimination, and inverted-tariff opportunities to support cost optimization.
Import-Export Services Operational Support & Workflow Management
- Provide subject matter expertise across LRL TCIES, including Harmonized Tariff Schedule (HTS) classification, customs valuation, country-of-origin marking, and PGA compliance for U.S. imports and exports.
- Assign FDA product codes, affirmations of compliance, and labeling requirements; maintain complete, audit-ready documentation for clinical and research materials.
- Resolve regulatory holds, customs delays, and shipment exceptions by coordinating with FDA, brokers, couriers, and logistics providers, with emphasis on time- or temperature-sensitive materials.
- Partner with Regulatory Affairs to ensure accurate Investigational New Drug (IND) data supporting compliant U.S. importation.
- Support customs valuation determinations and documentation, including World Trade Organization (WTO) valuation methodologies, as needed.
Greenwood Innovation Center (GIC) – Global Supply Logistics Solutions (GSLS) & Enterprise Control Tower Integration
- Provide tailored trade compliance support for Global Supply Logistics Solutions (GSLS) operations within the Greenwood Innovation Center (GIC), embedding customs and regulatory requirements into global clinical supply logistics.
- Serve as the TCIES subject matter expert for trade compliance integration into the Enterprise Control Tower, strengthening real-time visibility, risk identification, escalation protocols, dashboards, and decision support across LRL supply chain operations.
Trade Compliance Governance & Cross-Functional Coordination
- Support alignment of trade compliance policies across LRL, including export licensing, FTZ frameworks, and trade-sanctions protocols, in coordination with the Senior Director – LRL Trade Compliance and USIEC.
- Coordinate audits, reporting, regulatory filings, and compliance assessments; identify and remediate gaps to reduce regulatory exposure.
- Monitor U.S. and international regulatory developments and support continuous improvement to sustain LRL’s compliance posture.
- Support Lilly acquisition workstreams and integrations by incorporating incoming operations into TCIES frameworks with minimal disruption.
Operational & Strategic Support
- Develop and enhance internal controls, tools, and standard operating procedures to support a robust trade compliance environment across LRL.
- Partner with external logistics providers, customs brokers, couriers, CMOs, and suppliers to ensure alignment, transparency, and risk mitigation.
- Provide training and mentoring to TCIES personnel on trade compliance fundamentals, FTZ requirements, HTS classification, and standard procedures to ensure consistent execution.
Minimum Qualification Requirements
- Bachelor’s degree in supply chain management, international business, biology, chemistry, or a related field.
- 7+ years of progressive experience in U.S. import/export operations and trade compliance, including Foreign-Trade Zone administration and regulatory compliance.
- Experience in a regulated environment (e.g., pharmaceutical, life sciences, or similarly regulated industry) with strong documentation and audit-readiness expectations.
- Expertise in U.S. trade regulations, including CBP requirements, Harmonized Tariff Schedule (HTS) classification, customs valuation, and Partner Government Agency compliance (FDA, USDA, USFWS, EPA).
- Working knowledge of Foreign-Trade Zone regulations (19 CFR Part 146), including admissions, inventory control/recordkeeping, manufacturing determinations, privileged foreign and zone-restricted status, and weekly entry procedures.
- Strong analytical, communication, and interpersonal skills; ability to anticipate risk, solve problems, and partner effectively across functions.
Additional Preferences
- Licensed U.S. Customs Broker or NCBFAA Certified Customs Specialist (CCS).
- Master’s degree in international trade, supply chain, law, or a related discipline.
- Direct, hands-on experience administering or overseeing FTZ operations in a pharmaceutical or life sciences manufacturing environment.
- Experience supporting trade compliance aspects of mergers, acquisitions, or business integrations.
- Familiarity with Enterprise Control Tower platforms and their application to trade compliance monitoring and supply chain visibility.
Additional Information
This role requires extensive cross-functional collaboration with Legal, Procurement, Tax, Logistics, Customer Service, Trade Compliance, Regulatory Affairs, and international affiliates. Success depends on building strong partnerships, establishing clear processes and controls, and applying sound judgment to manage risk while enabling business objectives.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$115,500 - $169,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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