Senior Labeling Project Coordinator

• Serve as a labeling subject matter expert and provide guidance across Regulatory Affairs, Legal, Package Engineering, and Quality Assurance
• Review and approve label design templates
• Lead and support complex labeling projects requiring independent judgment and innovative problem-solving
• Manage cross-functional labeling implementation activities to execute product labeling changes accurately and within required timelines
• Coordinate new labeling implementation with Materials Management and multiple manufacturing or packaging sites
• Drive completion of complex labeling processes while ensuring regulatory and business compliance
• Develop and recommend process improvements for labeling operations and workflows
• Author, revise, and improve systems, procedures, and SOPs
• Ensure labeling activities comply with FDA regulations, cGMP requirements, and applicable regulatory guidance documents
• Facilitate cross-functional communication and alignment to resolve labeling issues
• Support continuous improvement initiatives focused on labeling accuracy, compliance, consistency, and operational excellence

• At least 5 years of relevant experience with a BS/BA degree, OR at least 4 years of relevant experience with an MS degree
• Pharmaceutical industry experience required
• Strong knowledge of FDA regulations, cGMP requirements, and regulatory guidance documents
• Demonstrated expertise in product labeling operations and labeling implementation processes
• Strong verbal communication, technical writing, and interpersonal skills
• Experience managing complex cross-functional projects and stakeholder relationships
  
  Proficiency with Microsoft Office applications
• Ability to develop process improvements, drive operational changes, and work effectively in ambiguous or evolving environments
• Labeling experience preferred

Demonstrates expertise in product labeling operations, ensuring compliance with FDA regulations and cGMP requirements while driving process improvements and managing complex cross-functional projects effectively.

• FDA Regulations
• CGMP Requirements
• Product Labeling Operations
• Cross-Functional Project Management
• Technical Writing

• Labeling Implementation Processes
• Process Improvements
• Regulatory Guidance Documents
• Label Design Templates
• SOP Development

• Verbal Communication
• Interpersonal Skills
• Problem-Solving

• Pharmaceutical Industry
• Labeling Compliance
• Operational Excellence

• Microsoft Office