Senior Clinical Supplies Specialist

This is a fully remote position, open to applicants in Mexico, +3 more states.

📋 Description

• Lead the external packaging, labeling, and distribution efforts for designated clinical studies, ensuring adherence to established timelines, quality standards, and GMP requirements.

• Collaborate with third-party contractors, internal teams, and supply chain partners to outline technical specifications, evaluate feasibility, and address operational risks.

• Supervise clinical supply documentation, including packaging specifications, labeling content, batch records, and readiness activities for execution.

• Manage interactions with external vendors to track progress, troubleshoot issues, and ensure compliance with study requirements and performance expectations.

• Monitor study milestones, supply operations, and key performance indicators, providing transparent status updates to project teams and stakeholders.

• Assist in the execution of new external supply strategies, supplier onboarding processes, and ongoing improvement initiatives.

• Guarantee precise, compliant, and inspection-ready documentation while upholding data integrity throughout clinical supply operations.

• Serve as a subject matter expert in clinical packaging, labeling, distribution, and associated supply chain processes.

⛳️ Requirements

• A bachelor's degree in supply chain management, logistics, life sciences, or a similar field.

• Extensive experience in clinical supplies, packaging operations, supply chain management, or logistics within the pharmaceutical, biotechnology, or CRO sectors.

• A robust understanding of Clinical Trial Supply processes, including packaging, labeling, distribution, and inventory management.

• Comprehensive knowledge of GMP, GDP, GCP, and global regulatory standards related to clinical supplies.

• Experience overseeing third-party contractors, external vendors, or outsourced clinical supply activities.

• Strong project coordination and stakeholder management capabilities with the proficiency to handle multiple priorities in a matrix environment.

• Exceptional organizational, analytical, and problem-solving skills, with a keen attention to detail.

• Effective communication and influencing abilities, capable of collaborating across various functions and organizational levels.

• Proven dedication to quality, compliance, and continuous improvement.

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.