Labeling Strategist

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Requirements:

• Extensive regulatory affairs knowledge and familiarity with RA concepts, procedures, practices, and industry standards.
• Knowledge of global labeling regulatory requirements, standards and processes.
• Demonstrated understanding of product development is required, and a comprehensive understanding of biology and pharmacology relevant to the therapeutic area.
• Analytical thinking and critical judgment.
• Ability to work and manage multiple assignments and timeline driven priorities.
• Substantial project management skill, with demonstrated ability in planning, implementing, and executing tasks to meet RA goals.
• Ability to independently develop solutions that are thorough, practical, and consistent with functional objectives.
• Demonstrated ability to lead teams.
• Interpersonal, organizational and negotiation skills.
• Strong technical writing skills.
• Strong collaboration, presentation, verbal and written communication, interpersonal, and leadership skills.
• Demonstrable conflict resolution and negotiation skills.
• Excellent project management, and attention to detail.
• Experience working in a Regulatory Information Management system.
• Proficiency utilizing Microsoft Suite – Outlook, Word, Excel, PowerPoint.
• Degree in life science or medicine
• Experience in Pharmaceutical Industry Regulatory Affairs and /or product labeling
• Expertise in product labeling within a Therapeutic Area
• Knowledge of FDA, EMA, and other international regulations for labeling
• Experience in managing individual and group projects of high to moderate complexity
• Experience working in a Veeva/Documentum-based document management system

Responsibilities:

• Chairs/leads Labeling Working Group and presentations to Cross-Functional Executive Labeling Board meetings.
• Leads the development and maintenance of core labeling documents including Core Data Sheet (CDS), core patient information leaflet (cPIL), and core instructions for use (cIFU)and regional labeling such as the US Prescribing Information (USPI), US patient labeling such as the patient prescribing information (PPI) and medication guide.
• Represents labeling on product-specific global regulatory teams and informs on GRT decision which impact any relevant portfolio assets,
• Provides input and leads the strategic guidance to Target Product Labeling,
• Manages compounds with a medium to high degree of complexity from a labeling perspective.
• Provides strategic guidance on labeling regulations, requirements, competitor labeling, and labeling trends to other Labeling Strategist across the regulatory organization.
• Advises internal and/or external experts on the creation of high-quality documents supporting changes to the core labeling documents and manages the annotations within those documents.
• Provides strategic labeling advice for major regions and works with cross functional teams to ensure that the execution of global regulatory labeling plans are aligned with global regulatory strategies.
• Reviews and provides feedback and approves deviations from core labeling.
• Ensures deviations from labeling procedures and policies are escalated appropriately.
• Assists in preparation of responses to labeling-related Health Authority queries.
• Manages the review and approval of core DHCP letters.
• Contributes to Annual Reports/ DSURs/ PBRERs/ Product Quality Complaint reviews.
• Collaborates on provides tangible solutions to labeling issues.
• Supervises direct reports and supports their career development, if applicable.
• Represents labeling on product-specific global regulatory teams.