Job Description

Job Summary

Responsible for working with cross-functional teams across the organization to drive and align the development and maintenance of global labeling (e.g. CCDS, regional product labels, and patient labeling) for assigned compounds. Makes recommendations and provides labeling advice and feedback for labeling content, processes, and timelines to ensure compliance with labeling regulations and guidance. Delivers high-quality submission labeling and artwork for complex drug products, specific therapeutic/disease areas, and cross functional teams. Actively contributes to continuous improvement of end-to-end labeling processes and systems.

Job Description

• Act as Global Labeling Strategy Lead, supporting preparation, review, and update of content for the development and maintenance of Company Core Data Sheet (CCDS), local labeling and labeling components.
• Lead the cross-functional labeling team for assigned compounds to drive alignment of labeling content and strategy.
• Partner with Global Regulatory Affairs to ensure that all labeling is aligned with the product global strategy and key messaging.
• Evaluate and communicate risks associated with CCDS content updates and implementation strategies.
• Drive labeling for package labeling (artwork) development, update, and maintenance through collaboration with a cross-functional team.
• Support global HA interaction strategy regarding all aspects of labeling, including submissions, responses to questions, and negotiations.
• Demonstrate understanding of current labeling content requirements, regulations, and guidance to ensure all assigned compound labeling documents are accurate, consistent, and compliant.
• Assess competitor labeling in the same therapeutic class, competitor labeling and labeling trends, proposing content as relevant to support optimized labeling
• Support creation, compliance, update, and submission of SPL, including drug listing and establishment registration activities. Ensure that FDA postings are current and accurate (DailyMed, NDC Directory, Establishment Directory, etc).
• Manage and maintain labeling documents in document management systems; Manage label review and approval.
• Author, contribute, and/or review labeling sections of various periodic reports (i.e., Annual Report, PSUR, PADER, etc.).
• Support inspection readiness activities related to all global labeling components.
• Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate.
• Collaborate with global Otsuka colleagues, Otsuka affiliates and Alliance partners, as needed.
• Develop clear communications for senior management and labeling stakeholders, to streamline and facilitate label development, negotiations, and approval.
• Review and propose continuous improvements to Global Labeling policies, end-to-end processes, quality, and system tools.
• May be assigned additional responsibilities, as deemed necessary.

Qualifications

Required

• MS/BS in life sciences or other scientific field.
• 6-8 years of relevant experience in pharmaceutical regulatory/labeling environment and/or drug development
• Knowledge of scientific principals and regulatory systems, relevant to drug development

• Experience writing CCDS and local labeling documents for new products.

Preferred

Knowledge and skills

• Solid understanding and practical knowledge of labeling regulatory requirements, regulations and guidance required
• Solid understanding of implications of global labeling across the organization and globally
• Solid understanding of the structure of product labeling
• Experience in effectively/appropriately prioritizing and managing multiple high to medium complex projects simultaneously
• Ability to work independently or in teams, globally. Ability to lead broad range of stakeholders at all levels internally and externally to the company.
• Effective written and oral communication and organizational skills
• Strong attention to detail
• Solid aptitude for use of IT systems; preferable knowledge with Regulatory Information Management System (RIMS) and electronic document management system (EDMS); Proficiency in MS Office suite; Willing to learn additional applications
• Ability to think strategically, communicate risks, and recommend problem solving innovative solutions
• Ability to recognize and escalate issues
• The ideal candidate should be action oriented, customer focused, ability to manage workloads and set priorities. In addition, he/she should be capable of dealing with ambiguity, be creative, be comfortable working with multifunctional teams.

Job Tags

Similar Jobs