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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in international pharmaceutical logistics and supply chain management, ensuring compliance with GxP regulations and optimizing clinical supply distribution processes. Proficient in managing vendor relationships, regulatory documentation, and customs clearances while maintaining effective communication with stakeholders.
Highest-signal resume keywords
International Pharmaceutical LogisticsClinical Supply DistributionGxP Regulations ComplianceCold Chain ManagementStakeholder Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Supply Chain ManagementRegulatory Documentation MaintenanceCustoms Clearance ManagementProcess OptimizationDatabase ManagementTemperature Excursion ManagementImport/Export CompliancePharmaceutical Supply Chain RequirementsHarmonization Tariff System (HTS)Drug Product Delivery
Soft Skills
Excellent Oral CommunicationExcellent Written CommunicationStrong Stakeholder ManagementSupervisory Skills
Tools & Technologies
MS OfficeSpecialized Computer Applications
Industry Keywords
Clinical Supply ChainPharmaceutical IndustryBiotech IndustryGMP RegulationsInternational Trade ComplianceCustoms ValuationVAT/Tax ManagementRisk ManagementINCOTERMSDangerous Goods Guidelines
About the role
Key responsibilities & impact- Implement global logistics and distribution strategies for the clinical supply chain
- Ensure uninterrupted availability of clinical supplies to clinical sites and patients
- Set up depot networks
- Ensure compliance with international import and export guidance and GxP regulations
- Execute shipments, including shipper solutions and transit temperature monitoring device utilization
- Oversee vendors and function as an area Subject Matter Expert
- Maintain regulatory documentation, transit documents, and customs clearances
- Partner with Trade Compliance experts on customs valuation, VAT/tax management and reclamation, and risk management through INCOTERMS
- Own site-by-site drug product shipments, importation document management, temperature excursion management, returns, destruction, and reconciliation
- Oversee distribution data maintenance and compilation to support budget creation and adherence
- Liaise with clinical operations and clinical supply chain project teams to resolve project issues
- Develop and maintain a database of country requirements, import/export requirements, Health Authority lead times, transit lead times, and country/region-specific considerations
- Improve vendor service and performance through governance models, regular communications, and established KPIs
- Supervise staff
Requirements
What you’ll need- BS/BA degree in related discipline and a minimum of eleven years of related experience; or MS/MA degree in related discipline and a minimum of nine years of related experience; or equivalent combination of education and experience
- Technical experience in international pharmaceutical logistics and supply chain
- Experience in the pharmaceutical and biotech industries
- Strong knowledge and demonstrated experience in clinical supply distribution
- Working knowledge of regulations relating to clinical supply distribution activities
- Working knowledge of GMP regulations
- Excellent oral and written communication skills
- Strong stakeholder management skills
- Technical skills and mindset in logistics and cold chain management, including process optimization and delivery of drug product
- Experience with pharmaceutical supply chain requirements and international trade compliance laws and regulations, including imports, exports, Harmonization Tariff System (HTS), country of origin, customs valuations, and dangerous goods guidelines
- Demonstrated experience maintaining a database of import data in full compliance with US Customs reporting requirements
- Proficient with MS Office and specialized computer applications as needed
- Supervisory experience or ability to supervise staff
Benefits
Comp & perks- 401k plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program
- Opportunity to purchase company stock
- Long-term incentives
- 15 accrued vacation days in the first year
- 17 paid holidays including a company-wide winter shutdown in December
- Up to 10 sick days throughout the calendar year
- Necessary equipment, including dual monitors and ergonomic chairs