Industry: Pharmaceuticals & Biotech•
8 - 10 years
Posted 241 days ago
Leads the process for content development and maintenance for labeling and labeling components. The ideal candidate will be results-oriented with concerns for quality and collaboration. They will demonstrate a high-level understanding of labeling content requirements, regulations and guidance in support of labeling strategies. May be assigned additional responsibilities as deemed necessary.
• Supervises direct and indirect report(s) or acts to ensure all labeling materials follow relevant laws and regulations.
• Analyses and interprets new regulations and guidances as well as monitors and determines the impact of the regulatory environment and applicable regulatory decisions affecting labeling.
• Plan and lead cross-functional labeling team meetings to discuss and develop label content for new molecular entities (NMEs), developmental and mature brand products.
• Establish global labeling and operational support for all local subsidiary labeling requests to fulfill and meet local health authority requests and deadlines.
• Ensure consistency of core company position(s) and scientific accuracy for all global labeling components (ROW, U.S. and E.U.) through active communication and collaboration.
• Moderate and liaise with subject matter experts based on functional area(s) to resolve labeling issues or meet regulatory/health authority timelines.
• Follows and formulates improvements to labeling policies, processes, quality, and system tools.
• Provide creative and innovative ideas to move the Global Labeling and Regulatory department to address current and future challenges
• PhD/MS/DVM/MD/BS in life sciences, scientific, or engineering field.
• 7+ years of relevant experience in pharmaceutical regulatory/labeling environment.
• Demonstrated ability to work with and manage people in a global, dynamic environment to deliver value-added results.
Knowledge, Skills and OtherExperience
• Solid understanding of global labeling regulatory requirements and industry practice
• Broad knowledge of clinical, CMC preclinical and clinical pharmacology
• Excellent understanding of medical concepts and terminology
• Solid understanding of the structure and function of product labeling
• Fundamental understanding of the pharmaceutical industry drug development process
• Strong written and oral communication skills
• Good computer skills including experience with XML including SPL systems, MS Office: Word, Excel, PowerPoint, and Outlook and Adobe products
• Action oriented, customer focused, ability to manage workloads, set priorities, and have demonstrated the ability to build effective teams. Must be able to deal with ambiguity.
• Ability to generate problem solving innovative solutions and motivate others to be innovative.