BioSpace, Inc.
Overview
Manager, Global Trade Compliance (remote) reporting to the Senior Director Global Clinical Supply Chain Import Export Operations and Global Trade Compliance. The role focuses on ensuring that Clinical and R&D imports and exports comply with applicable laws and regulatory requirements across affected countries, with emphasis on process improvements and collaboration with global locations. Responsibilities
Contribute to the creation and adherence of export and import compliance policies and procedures for Clinical Trial Material (CTM) and raw material shipments. Manage daily import and export transactions, ensuring compliance with US Government Laws and Regulations (e.g., US Customs and Border Protection, USDA, FDA, Fish & Wildlife, Public Health, BIS, DEA, FAA) and generate shipping documentation; collaborate with requesters on import/export specifics. Ensure adherence to country-specific SOPs for importing/exporting clinical trial material and raw materials, including logistics, customs clearance, and delivery cycle times. Liaise with in-country coordinators/CROs to establish and maintain standard import and export requirements for clinical trials, including export license determination. Maintain international product data for development compounds (Country of Origin, Harmonized Tariff Codes, ECCN, PGA Licenses & Permits, FDA product codes, INDs for raw materials, chemical intermediates, finished goods). Instruct customs brokers and freight forwards on handling import/export transactions; conduct post-entry review to ensure compliance with US import regulations. Provide guidance and valuation for non-commercial materials using WCO/WTO best practices. Identify, forecast, and mitigate import VAT costs across multiple tax regimes. Identify opportunities for process improvements and implement solutions to eliminate compliance deficiencies. Collaborate with global colleagues in Clinical Supply Chain Operations and Legal to align import/export compliance activities within Takeda. Verify international product data for CLINICAL AND RESEARCH AND DEVELOPMENT SUPPLIES (Country of Origin, Tariff Code/Schedule B, ECCN, FDA product codes, NDAs, INDs for raw materials, chemical intermediates, finished goods) as determined by the Trade Compliance group. Education And Experience
Bachelors degree, preferred in Business or Science. US Customs Broker License required. Experience with South American customs required. 6 or more years of experience in importing and exporting in a technical industry involving chemicals and controlled materials. Expert knowledge of the Export Administration Regulations (EAR) required. Knowledge and ability to interpret EU, US and MERCOSUR customs regulations and apply to Takeda businesses required. Solid understanding of US Automated Export System via ACE required. Export auditing experience preferred. Bonded Warehousing and Free Trade Zone experience preferred. Well-developed supply chain knowledge preferred. Excellent communication, organizational, interpersonal, and writing skills and personal judgment. Ability to work independently and exercise independent sound judgment. Ability to clearly advise, explain and discuss material and complex matters with internal colleagues and external customers. Ability to develop, present, and follow through on innovative solutions. Must be a team player; ability to develop and utilize collaborative relationships. Leadership skills ability to lead and train cross-functional project teams. Compensation And Benefits
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. Location: Cambridge, MA U.S. Base Salary Range: $111,800.00 - $175,670.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on qualifications, experience, skills, and location. The actual base salary will comply with state or local minimum wage requirements. U.S. based employees may be eligible for short-term and/or long-term incentives, and for medical, dental, vision insurance, a 401(k) plan with company match, disability coverage, life insurance, tuition reimbursement, paid volunteer time off, holidays, and well-being benefits. New hires may accrue paid time off and other leave, as applicable. EEO Statement
Takeda is proud of its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or protected characteristics in accordance with applicable laws. Locations
Cambridge, MA Worker Type
Employee Worker Sub-Type
Regular Time Type
Full time Job Exempt
Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment. Violations may result in penalties. #J-18808-Ljbffr
Manager, Global Trade Compliance (remote) reporting to the Senior Director Global Clinical Supply Chain Import Export Operations and Global Trade Compliance. The role focuses on ensuring that Clinical and R&D imports and exports comply with applicable laws and regulatory requirements across affected countries, with emphasis on process improvements and collaboration with global locations. Responsibilities
Contribute to the creation and adherence of export and import compliance policies and procedures for Clinical Trial Material (CTM) and raw material shipments. Manage daily import and export transactions, ensuring compliance with US Government Laws and Regulations (e.g., US Customs and Border Protection, USDA, FDA, Fish & Wildlife, Public Health, BIS, DEA, FAA) and generate shipping documentation; collaborate with requesters on import/export specifics. Ensure adherence to country-specific SOPs for importing/exporting clinical trial material and raw materials, including logistics, customs clearance, and delivery cycle times. Liaise with in-country coordinators/CROs to establish and maintain standard import and export requirements for clinical trials, including export license determination. Maintain international product data for development compounds (Country of Origin, Harmonized Tariff Codes, ECCN, PGA Licenses & Permits, FDA product codes, INDs for raw materials, chemical intermediates, finished goods). Instruct customs brokers and freight forwards on handling import/export transactions; conduct post-entry review to ensure compliance with US import regulations. Provide guidance and valuation for non-commercial materials using WCO/WTO best practices. Identify, forecast, and mitigate import VAT costs across multiple tax regimes. Identify opportunities for process improvements and implement solutions to eliminate compliance deficiencies. Collaborate with global colleagues in Clinical Supply Chain Operations and Legal to align import/export compliance activities within Takeda. Verify international product data for CLINICAL AND RESEARCH AND DEVELOPMENT SUPPLIES (Country of Origin, Tariff Code/Schedule B, ECCN, FDA product codes, NDAs, INDs for raw materials, chemical intermediates, finished goods) as determined by the Trade Compliance group. Education And Experience
Bachelors degree, preferred in Business or Science. US Customs Broker License required. Experience with South American customs required. 6 or more years of experience in importing and exporting in a technical industry involving chemicals and controlled materials. Expert knowledge of the Export Administration Regulations (EAR) required. Knowledge and ability to interpret EU, US and MERCOSUR customs regulations and apply to Takeda businesses required. Solid understanding of US Automated Export System via ACE required. Export auditing experience preferred. Bonded Warehousing and Free Trade Zone experience preferred. Well-developed supply chain knowledge preferred. Excellent communication, organizational, interpersonal, and writing skills and personal judgment. Ability to work independently and exercise independent sound judgment. Ability to clearly advise, explain and discuss material and complex matters with internal colleagues and external customers. Ability to develop, present, and follow through on innovative solutions. Must be a team player; ability to develop and utilize collaborative relationships. Leadership skills ability to lead and train cross-functional project teams. Compensation And Benefits
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. Location: Cambridge, MA U.S. Base Salary Range: $111,800.00 - $175,670.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on qualifications, experience, skills, and location. The actual base salary will comply with state or local minimum wage requirements. U.S. based employees may be eligible for short-term and/or long-term incentives, and for medical, dental, vision insurance, a 401(k) plan with company match, disability coverage, life insurance, tuition reimbursement, paid volunteer time off, holidays, and well-being benefits. New hires may accrue paid time off and other leave, as applicable. EEO Statement
Takeda is proud of its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or protected characteristics in accordance with applicable laws. Locations
Cambridge, MA Worker Type
Employee Worker Sub-Type
Regular Time Type
Full time Job Exempt
Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment. Violations may result in penalties. #J-18808-Ljbffr