Posted to MedZilla on 12/5/2019

Takeda Pharmaceuticals

US-MA, Import/Export Specialist R0011675-MZ


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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Import/Export Specialist in our Cambridge office.

As an Import / Export Specialist working on the Global Import / Export and Trade Compliance team, you will be empowered to manage the import and export shipments for the clinical trial programs you support.


The Import/Export Specialist is responsible for the preparation and coordination of export and import shipping documentation as well as adhering to compliance policies and procedures for Takeda Research and Development organizations. The position emphasizes managing Import/Export transaction requests, assisting management in the resolution of issues that may arise (during the shipments of clinical studies or movement of research materials), and includes interaction with customs brokers, freight forwarders and transportation service providers, and as necessary, with government officials from Customs, FDA, USDA, Fish and Wildlife Service and other participating government agencies.


Assist in the creation and adherence of export and import compliance policies and procedures for the organization regarding Clinical Trial Material (CTM) and raw material shipments.

Manage daily import and export transactions ensuring compliance to all US Government Laws and Regulations. This includes US Customs and Border Protection, USDA, FDA, Fish Wildlife, Public Health, Bureau of Industry and Security, DEA, FAA and possible other government agencies. This includes preparing formal responses for questions specific to imports or exports.

Adhere to 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.

Help to maintain all international product data for development compounds: Country of Origin, Harmonized Tariff Codes, Export Commerce Control Number (ECCN), PGA Licenses & Permits, FDA product codes, 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 import/export transaction. Conduct post-entry review audits ensuring transactions comply with US import regulations. If incorrect, provide instructions for entry corrections. Help conduct TSP performance assessments.

Review contracts and task orders to ensure international distribution pathways are aligned with the import/export regulations and the business needs.

Assist in CTM budget preparation and control activities by identifying customs duties and taxes.



Minimum (4 years) experience in R&D material management/project planning/clinical supplies including (2 years) experience in importing and exporting in pharmaceutical industry

Bachelor s Degree required, preferably in Business, Science or Law

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

Understanding of Automated Export System (AES)

  • Licensed Customs Broker License


Computer database and spreadsheet experience

Global Logistics experience

Certified U.S. Export Compliance Officer

Skills and Knowledge:

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


Ability to drive or fly to various meetings/ client sites limited overnight.

Some international travel may be required.

Approximately 5% travel.


  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs

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Boston, MA

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Full time

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