Senior Manager, Global Labelling Operations

🔥 22 minutes ago

🇺🇸 United States – Remote

💵 $150k - $224.3k / year

⏰ Full Time

🟠 Senior

⚙️ Operations

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

Pharmaceuticals • Healthcare • Biotechnology

Otsuka Pharmaceutical Companies (U. S. ) is a prominent player in the pharmaceutical manufacturing industry, dedicated to creating innovative products for better health worldwide. The company comprises two main entities: Otsuka America Pharmaceutical, Inc. (OAPI), which is focused on commercializing Otsuka-discovered and in-licensed products in North America, and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), which specializes in the clinical development and global registration of innovative healthcare solutions, particularly in the field of neuroscience.

📋 Description

• Support the RA Global Labeling Lead/Labeling Strategist in developing and managing the Company Core Data Sheet and local labeling • Partner on development, updating, and maintenance of package labeling and artwork • Represent Global Labeling on product-specific Regulatory and Cross-Functional teams • Collaborate with global Otsuka colleagues, affiliates, and alliance partners • Create competitor labeling and precedent documents • Ensure labeling complies with regional regulatory regulations, guidance, and requirements • Perform content reviews and quality-control checks for consistency across labeling documents and artwork • Support creation, compliance, updating, and submission of SPL, including drug listing and establishment registration activities • Keep FDA postings such as DailyMed, NDC Directory, and Establishment Directory current • Manage labeling documents in document management systems and manage label review and approval • Partner with Regulatory Managers to ensure labeling is submission-ready and available for publishing • Partner with Technical Operations and Supply Chain on label and artwork preparation for submission or packaging implementation • Author, contribute to, and review labeling sections of periodic reports including Annual Reports, PSURs, and PADERs • Contribute to continuous improvement of the end-to-end labeling process • Maintain Global Labeling Compliance activities, metrics, tracking, and documentation • Support labeling inspection and audit readiness activities • Ensure labeling components are maintained according to relevant laws and regulations • Monitor new formatting and quality requirements and assess their impact on product labeling • Suggest improvements to labeling policies, processes, quality, and system tools • Track labeling changes and implementation for assigned regions • Review and monitor end-to-end labeling compliance metrics • Act as labeling operations subject matter expert when evaluating new labeling technologies or systems • Assist the Global Labeling Lead/Labeling Strategist with additional tasks as needed

🎯 Requirements

• Bachelor’s Degree • At least 5-6 years of experience in labeling for drug development • Experience using electronic document management systems and/or electronic submissions • Solid understanding and interpretation of US labeling regulations, guidance, and precedent • Solid understanding of requirements for tracking labeling updates • Solid understanding of product labeling structure • Solid understanding of the pharmaceutical industry drug development process • Attention to detail • Problem-solving and decision-making skills, including ability to recognize and escalate issues • Excellent written and oral communication and organizational skills • Experience with document management systems and/or electronic submissions • Aptitude for using IT systems • Preferable knowledge of Documentum/electronic document management, Regulatory Information Management Systems (RIMS), XML-based systems, and comparative text quality control systems • Proficiency in Microsoft Word/Suite and Outlook Mail/Calendar • Willingness to learn additional applications as needed • Excellent proofreading skills • Ability to manage workloads and set priorities • Ability to work with multifunctional teams

🏖️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage • Company-provided basic life insurance • Accidental death and dismemberment insurance • Short-term and long-term disability insurance • Tuition reimbursement • Student loan assistance • Generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs • Other company-provided benefits • Incentive opportunity

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