Key Job Responsibilities
- Support of RA Global Labeling Lead (GLL)/Labeling Strategist during the development and life-cycle management of the Company Core Data Sheet (CCDS) and Local Labeling, as needed.
- Partner with RA Global Labeling Lead GLL/Labeling Strategist in development, update and maintenance of package labeling (artwork).
- 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.
- Create competitor labeling and precedent documents to support development of labeling.
- Ensure labeling is in accordance with all current regional regulatory regulation, guidance and requirements. Content reviews and QC checks are performed to ensure consistency between internal labeling documents (i.e.., Core Data Sheet and other core labeling documents) and all local/regional labeling and supportive documents, including artwork.
- Support creation, compliance, update and submission of SPL, including drug listing and establishment registration activities. Ensure that FDA postings (DailyMed, NDC Directory, Establishment Directory, etc) remain current.
- Manage and maintain labeling documents in document management systems; Manage label review and approval
- Partner with Regulatory Managers to ensure that all labeling is submission ready and available for publishing
- Partner with Technical Operations and Supply Chain for preparation of labels and labeling into artwork for submission and/or implementation into packaging.
- Author, contribute, and/or review labeling sections of various periodic reports (i.e., Annual Report, PSUR, PADER, etc)
- Contribute to the continuous improvement of the end-to-end labeling process including excellent proofreading / editing skills and compiling supportive documentation
- Support and maintain Global Labeling Compliance activities and initiatives, including metrics, tracking and documentation
- Support labeling inspection/audit readiness activities
- May be assigned additional responsibilities, as deemed necessary
- Ensures that all labeling components are appropriately maintained according to relevant laws and regulations.
- Ensures compliance with new formatting and quality requirements and monitors and determines their impact on product labeling
Knowledge, Skills, and Competencies
- Proactively suggests improvements to labeling policies, processes, quality, and system tools
- Tracks all labeling changes and implementation for assigned regions
- Review and monitor compliance metrics for end to end labeling process
- Acts as labeling operations subject matter expert when a new labeling technology and/or system is being evaluated
- Highly motivated and results-oriented individual, with concerns for quality and collaboration. Should demonstrate initiative and the drive to continue to develop and acquire new expertise
- Solid understanding and interpretation of US labeling regulations, guidance and precedent
- Solid understanding of requirements for tracking of labeling updates
- Solid understanding of the structure of the product labeling
- Solid understanding of the pharmaceutical industry drug development process
- Attention to detail
- Possess problem-solving and decision making skills with the ability to recognize and escalate issues
- Excellent written and oral communication and organizational skills
- Problem Solving
- Prior experience with document management systems and/or electronics submissions is required.
- An aptitude for the use of IT systems; preferable that they have knowledge of Documentum/electronic document management, Regulatory Information Management Systems (RIMS), XML-based and comparative text quality control systems. Proficiency in standard office technology, including Microsoft Word/Suite, Outlook Mail/Calendar and willing to learn additional applications as needed
- Proofreading of labeling documents
- Assist Global Labeling Lead/Labeling Strategist with other tasks, as needed
The ideal candidate should be action oriented, customer focused, can manage workloads, and set priorities. In addition, he/she should be capable of dealing with ambiguity and be comfortable working with multifunctional teams.Education and Related Experience
- Bachelor's Degree plus at least 5-6 (Manager) years of experience in labeling for drug development
- Candidates having electronic document management systems use and or electronic submission experience
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.Disclaimer:
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.Valid Proof of COVID-19 Vaccination or Accommodation
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