Senior Clinical Supply Operations Specialist

Regeneron Pharmaceuticals, Inc.; Warren (MI); Presencial; USD 95 000 - 125 000; Tempo integral

Resumo da oferta

Regeneron Pharmaceuticals, Inc. seeks a Senior Clinical Supply Operations Specialist to oversee investigational product distribution, ancillary supplies, and comparator procurement across clinical trials.

The role focuses on inventory planning, shipment coordination, and regulatory documentation in support of trial integrity. You will collaborate across functions, manage IP shipments and depot transfers, and contribute to budgeting and forecasting while ensuring compliance with ICH/GCP

Qualificações

• Bachelor's degree in related field
• 3+ years clinical supplies, QA/regulatory, or biopharma supply chain experience
• Knowledge of clinical drug development, ICH/GCP, and regulatory guidelines
• Proficiency in MS Word and Excel
• Strong problem-solving, time management, and organizational skills
• Ability to communicate effectively and collaborate across organizations

Responsabilidades

• Manage investigational product supply planning, inventory reconciliation, and destruction activities
• Oversee IP shipments, depot transfers, and temperature excursion management
• Maintain electronic trial master files and regulatory documentation per compliance requirements
• Support ancillary supply procurement, planning, and international logistics coordination
• Lead financial forecasting, budgeting, and comparator drug procurement processes

Conhecimentos

Clinical supplies

Regulatory knowledge

Cross-functional collab

Forecasting

Formação académica

Bachelor's degree in related field

Ferramentas

MS Word

MS Excel

Descrição da oferta de emprego

Regeneron seeks a Senior Clinical Supply Operations Specialist to manage investigational product distribution, ancillary supplies, and comparator procurement across clinical trials. The role involves inventory planning, shipment coordination, regulatory documentation, and cross-functional collaboration in Warren, NJ or Armonk, NY.

Responsibilities

• Manage investigational product supply planning, inventory reconciliation, and destruction activities
• Oversee IP shipments, depot transfers, and temperature excursion management
• Maintain electronic trial master files and regulatory documentation per compliance requirements
• Support ancillary supply procurement, planning, and international logistics coordination
• Lead financial forecasting, budgeting, and comparator drug procurement processes

Requirements

• Bachelor's degree in related field
• 3+ years clinical supplies, QA/regulatory, or biopharma supply chain experience
• Knowledge of clinical drug development, ICH/GCP, and regulatory guidelines
• Proficiency in MS Word and Excel
• Strong problem-solving, time management, and organizational skills
• Ability to communicate effectively and collaborate across organizations