• 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.
• 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
Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.
In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying creativity in everything it does.
Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 50,000 people worldwide and had consolidated sales of approximately USD 11 billion (€ 9.9 billion) in 2016.
All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.
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.