Senior Specialist - Logistics & Global Trade Compliance

About the Department
Our Research & Development organization brings together the best minds in life science innovation. The teams located in facilities in Boulder, Lexington, Watertown, Cambridge and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients.
The Position
The Specialist, Logistics & Global Trade Compliance is responsible for enforcing company-wide compliance with US Customs regulations and internal policies/procedures concerning the import and export of goods which protects Novo Nordisk against Custom's fines and penalties. This role ensures regulatory requirements are adhered to and proper documentation, including transit documents and customs clearances exist for imports and exports and are filed on time and completely. The specialist develops and maintains successful relationships with vendors (e.g., freight forwarders, custom brokers, etc.) and acts as a key SME in the area to support and lead process improvements.
Relationships
This position will report to the Senior Manager, Materials Management.
Essential Functions

• Primary point of contact for all activities regarding Logistics and Global Trade Compliance
• Ensure prompt shipment related communication to key internal and external stakeholders
• Initiate, monitor, and complete shipments associated with research material, raw materials, drug substance, drug product
• Reviews import documentation for accuracy and assign Harmonized Tariff Schedule (HTS) number in accordance with U.S. Customs regulations. This is critical to the US import compliance function, and it must be accurate to avoid monetary penalties and to ensure Novo Nordisk R&ED US import privileges are not revoked
• Facilitates, maintains, and monitors import databases, including reviewing for potential duties savings and process improvements, coordination, and upkeep of Import Survey workspace. The import databases are audited by US Customs and must be accurate
• Acts as intermediary and primary point of contact between in-house personnel and Customs Broker on all import/export transactions
• Resolves irregularities or ambiguous information for individual import transactions as needed
• Prepares all necessary data and confirmation of key milestones for shipments (departure, arrival, customs clearance, PODs, etc.)
• Responsible for authoring cGMP Standard Procedures
• Responsible for auditing customs brokerage and shipment transactions and files. Expertise in multiple areas of import and export laws such as HTS Classification, Country of Origin, Free Trade Agreements, Customs Valuation
• Directly responsible for taking corrective action when there are issues with non-compliance
• Conducts monthly review of exports reported through AES to ensure accuracy and completeness
• Supports internal audit and responsibility for writing and updating Customs Standard Operating Procedures (SOP's) as needed
• Authoring and implementing quality management system policies and SOPs for process establishment and efficiencies
  • Provide trainings for internal stakeholders and new employees

• Improve tracking system for shipments
  • Leverage Novo Nordisk HQ processes and contracts where appropriate to improve the shipping process
• Management of outsourced inventory (Raw Materials, Drug Substance, Drug Product)
  • Lead continuous improvement activities at outsourced CMOs
  • Review and execution to discard expired material as needed at warehouses to ensure inventory optimization

• Drive the internal and external investigation of errors or non-conformances, and preparing corrective and preventative action plans (CAPAs) in conjunction with QA and impacted departments
• Import/export expertise - ensure trade compliance with regards to imports and exports
  • Filings with Customs broker and US Customs and Border Protection
  • HTS classification and material valuations to ensure material is identified appropriately
  • Incoterms to ensure shipment terms are appropriate

• Ad-hoc shipping and logistics projects
• Review and analysis of temperature-controlled shipments to maintain temperature requirements in transit
  • Filing of temperature/quality events as needed

Physical Requirements
Travel 10%. Travel to other Novo Nordisk locations, storage facilities, CMO's may be required up to 10% of the time.
Qualifications

• Bachelor's degree in Science, Business, or related discipline with five (5) years of experience in pharmaceutical or related industry required
• Master's degree with three (3) years of experience in pharmaceutical or related industry required
• The position requires teamwork, organization and influencing skills with a strong focus on customer service for both internal and external stakeholders
• Ability to communicate effectively to all levels of the organization
• Excellent presentation skills
• Attention to detail
• Ability to effectively function and manage in a highly dynamic, fast paced work environment
• Strong organizational skills
• High quality focus
• Strong business acumen
• Customer orientation
• Detailed knowledge of import/export requirements for GMP and raw materials
• Excellent knowledge of logistics procedures
• CPIM/CLTD/CSCP certification a plus
• Familiarity with CFR 19, 7, 9, 42, 49, 50, 40 and 21
• Demonstrated ability to work independently and with cross-functional teams, including Supply Chain, CMC, Quality, Finance, R&D
• Proficient in Microsoft Excel

The base compensation range for this position is $98,000 to $145,000. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance.
Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.
Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.