Job Summary:
The Clinical Supply Chain Specialist oversees transportation activities for clinical supply chain and development operations, ensuring compliance with domestic and international import/export laws. This role requires expertise in troubleshooting international freight issues. The Specialist facilitates effective communication and manages freight handling throughout transportation processes.
Key Responsibilities:
- Coordinate inbound and outbound logistics across development, clinical, and commercial functions, collaborating with internal teams and external partners.
- Supervise transportation activities conducted by freight forwarders, carriers, and customs brokers.
- Monitor and document on-time and complete delivery of products to third-party warehouses and commercial partners.
- Ensure compliance with global import/export regulations, reviewing and coordinating documentation with vendor partners, carriers, and brokers.
- Maintain records of inventory movements and shipments according to policy.
- Track critical shipments and resolve transportation issues promptly.
- Collaborate with quality teams to report, investigate, and address shipping events and deviations using eQMS.
- Identify risks to drug supply and develop mitigation strategies in coordination with internal stakeholders.
- Manage and document shipping lanes for clinical and commercial supply shipments.
- Conduct shipping studies in conjunction with packaging engineers.
- Administer the Transportation Management System (TMS), updating vendor and commodity information as needed.
- Review carrier invoices for accuracy and process accounts payable discrepancies promptly.
- Stay informed about changes in shipping regulations and conduct impact assessments for logistics-related change controls.
- Develop standard operating procedures (SOPs) and work instructions as necessary.
- Support departmental and corporate goals through ad hoc projects as assigned.
Education, Experience, and Skills:
- Bachelor's degree in a related field with a minimum of three years of experience, or a Master's degree with at least one year of experience; or equivalent combination of education and experience.
- Experience in global transportation logistics, including cold chain logistics and commercial supply chain logistics.
- Strong understanding of global import/export regulations and documentation requirements.
- Knowledge of GxP principles related to transportation.
- Proficiency in Microsoft Office applications, particularly Excel and Outlook.
- Ability to prioritize and manage multiple tasks under tight deadlines.
- Familiarity with pharmaceutical supply chain processes and ability to build effective relationships internally and externally.
- Excellent communication skills, both written and verbal.
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