Karen Wend, MBA
About Karen Wend, MBA
Karen Wend, MBA, is the Associate Director, Global Regulatory Information Management Lead at Bristol Myers Squibb in Lawrenceville, New Jersey. She has extensive experience in regulatory information management and project management within the pharmaceuticals industry.
Company: Bristol Myers Squibb
Karen Wend is currently employed at Bristol Myers Squibb as the Associate Director, Global Regulatory Information Management Lead. With years of experience in various roles within the company, her tenure includes positions such as Associate Director of Regulatory Information Management, Regulatory Information Manager, Project Operations Manager (HR), and several consulting roles. Karen's extensive background with Bristol Myers Squibb underscores her expertise and commitment to the pharmaceutical industry.
Title: Associate Director, Global Regulatory Information Management Lead
Holding the position of Associate Director, Global Regulatory Information Management Lead at Bristol Myers Squibb, Karen Wend leads the management of global regulatory information. Her role involves overseeing the efficient handling of regulatory documentation and ensuring compliance with industry standards and regulations. This position leverages her extensive background in regulatory information management, project management, and business process improvement.
Education and Expertise: MBA from New York Institute of Technology
Karen Wend earned her Master of Business Administration (MBA) from the New York Institute of Technology, specializing in Business Administration and Management. This advanced education has equipped her with critical skills in business management, strategy, and leadership. Additionally, she holds a Bachelor’s degree in Manufacturing Engineering from Rochester Institute of Technology, providing a strong technical foundation. Her educational background supports her role in the pharmaceutical industry, particularly in regulatory management and process improvement.
Background: Extensive Pharmaceutical Industry Experience
Karen Wend's professional journey spans several prominent pharmaceutical companies. At The Janssen Pharmaceutical Companies of Johnson & Johnson, she contributed as a Consultant - Project Specialist. Her earlier roles include a Consultant - Adverse Event Analyst at Johnson and Johnson PRD, and various consultant positions at Schering-Plough and Wyeth Pharmaceuticals. These roles have honed her expertise in project management, regulatory information management, and adherence to FDA regulations.
Skills and Competencies: Root Cause Analysis and Technical Writing
Karen Wend is skilled in root cause analysis, a critical competency for identifying and addressing fundamental issues in business processes to prevent recurrence. Her strong technical writing skills are essential for creating clear and concise regulatory documents, ensuring compliance and effective communication. She also focuses on business process improvement, aiming to enhance organizational efficiency and effectiveness. Her comprehensive understanding of FDA regulations further enhances her capacity to manage regulatory information in the pharmaceutical sector.