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.