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Labeling Operations Associate
at Otsuka Pharmaceutical Company
Princeton, NJ

Labeling Operations Associate
at Otsuka Pharmaceutical Company
Princeton, NJ

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Description

Responsibilities

• The successful candidate will be results-oriented with concerns for quality and collaboration. They will show initiative and want to continue to develop and acquire new expertise
• Responsibilities of this position will include collaborating with Otsuka Japan, Otsuka affiliates and alliance partners on an effective and efficient process for the global distribution and tracking of labeling updates for products
• Disseminates and tracks approved labeling documents and supporting documentation for labeling compliance distribution and implementation requirements
• Team with Label Strategist to:


o Conduct international labeling operations activities to support global new product and supplemental applications from product registration, through post approval launches for impacted international markets
o Work with Regulatory Operations, Regulatory Affairs, Tech Ops, etc. for labeling distribution, tracking and quality control


• Populate and maintain labeling systems; follows FDA postings e.g., DailyMed, Drugs@FDA to ensure current
• Responsible for executing and effective quality control reviews and tracking (primarily) internal labeling documents (Core Data Sheet, Core Patient Information Leaflet, Core Instructions for Use) and outward facing local/regional labeling (USPI, Med Guide, EU SmPC, PIL, Canadian Product Monograph, Instructions for Use) as well as container and carton labels to meet regional regulatory requirements and ensure consistency between labeling, labels and supportive documents.
• Act as operational expert for the Global Labeling tracking in RIMs
• Ensure development and maintenance of templates, collaboration features and system upgrades
• Support SPL generation, including drug listing and establishment registration activities.
• Contribute to the continuous improvement of the end-to-end labeling process including excellent proofreading / editing skills and compiling supportive documentation
• Support labeling inspection/audit readiness activities
• Serve as a Global Regulatory Affairs contact for PSMF activities
• Collaborate with the Global Labeling Team to review and monitor safety variation tracking compliance metrics for CCDS related Safety Changes

• 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

• 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

• Solid understanding and interpretation of US labeling regulatory requirements preferred
• 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
• Ability to recognize and escalate issues
• Strong 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 Leads 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.

Qualifications

Required:


• 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

Overview

At Otsuka, we defy limitation, so that others can too.

We have an unwavering belief in doing more. In transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.
We believe that the bigger the challenge, the bigger the opportunity. We are doing everything in our power to live up to our mission of creating new products for better health worldwide in two important therapeutic categories: neuroscience and nephrology.

Our culture is rooted in our Japanese heritage and almost 100-year history. Otsuka-people live by the core principles of Jissho – the achievement, completion, and discovery of truth; and Sozosei – pursuing that which only Otsuka is capable of delivering. We approach our business and overcome challenges through perseverance, unconventional thinking and humility.
Learn more about Otsuka Pharmaceutical Company on its global website at http://www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.

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