Lead Director in Compliance & Oversight driving business compliance and efficiency in labeling and regulatory processes at Pfizer. Focused on process development, quality management, and continuous improvement in a global context.
Responsibilities
Drive overall business process, oversight, and compliance
Compile data from various sources, generate, analyze, and supply various reports
Support BPO framework and deliver core BPO responsibilities
Lead process development via translating business requirements into current and future processes
Create efficiencies with utilized technologies, identify new technologies
Lead projects from conception through execution
Act as primary business contact for labeling system development
Oversee End-to-End Labeling process, data quality, and compliance
Perform complex process and quality monitoring
Drive Continuous Improvement and Efficiency Efforts by using systems to analyze data and propose changes
Requirements
Bachelor’s Degree
Strong experience in global/multi-national pharmaceutical environment
Experience in Labeling or Regulatory Affairs role and clinical trial role
Experience with Business Analytics required
Experience participating in audits and preparing for inspections
Experience in interpreting and applying global and local regulatory guidance
Experience in labeling and/or artwork processes preferred
Proven fluency with use of soft skills and negotiation skills
Mastery of processes, tools and techniques for planning and monitoring multiple complex projects
Excellent knowledge of tools used to design processes and process flows
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