Manager, Global Labeling

Eisai • Nutley, NJ

1d

About The Position

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Develops, revises, tracks and approves packaging documents including issuance of Core Labeling Change Notifications, International Labeling Change Notifications, and New Core Labeling Notifications; artwork and mockup for all products. Ensures packaging content and artwork is compliant with internal labeling policies, standard operating procedures and worldwide health authority regulations. Maintains and tracks labeling/packaging documents in the labeling repository and/or electronic system. Monitors worldwide regulations pertaining to labeling and assists in the maintenance of standard operating procedures. Assists with preparing submission-ready labeling documents. Creates, reviews, and releases text that meets all medical, legal, and regulatory requirements for labeling medical products. Develops product labeling such as target product profiles (TPP), company core data sheets (CCDS), instructions for use, and safety data sheets. Monitors process of any changes in labeling regulations in the US and/or abroad. Reviews labeling change information, and ensures that it is supported by the data and consistent with the application. May review promotional and commercial communication material. Job Summary: Reporting to the Director of Global Labeling, the Manager, Global Labeling is responsible for supporting Global Labeling Leads in daily operational labeling activities (US and global); managing and maintaining US SPL, drug listings, and establishment registrations; triaging, reviewing, and tracking Country Product Information (CPI); and performing operational activities that support Global Labeling deliverables and responsibilities.

Requirements

• BS degree (or higher) in life science
• A minimum of 4 years of experience in the pharmaceutical industry is required
• A minimum of 2 years of experience in product labeling/labeling regulations is required
• Can demonstrate strong project management, problem solving, strategic thinking, negotiation, interpersonal and communication skills (both written and oral), attention to detail and ability to work under tight timelines, and across teams and regions
• Possess experience in both local and global regulatory labeling environments and work on multiple projects
• Must be a team-oriented individual with personal commitment to human relations, integrity, giving and receiving feedback, adaptability, and a diverse working environment
• Able to work under pressure and enforce company-wide standards
• Must possess a strong working knowledge of Microsoft Office applications, document management systems, labeling text verification systems as well as related labeling software and trackers

Responsibilities

• Collaborate with key stakeholders to facilitate and lead cross-functional teams in the development, review, approval, and maintenance of the establishment registration and drug listing (bulk and finished) in the US.
• Perform bi-annual review and submission of FDA-required drug listings and establishment registrations.
• Act as a Subject Matter Expert (SME) on US Structured Product Labeling (SPL): Provide guidance and support for the U.S. drug listings and Structured Product Labeling (SPL), partner with an external service provider to deliver on SPL commitments.
• Collaborate with global stakeholders and stay abreast of structured product labeling developments, requirements, and formats in rest of world
• Be familiar with National Drug Code (NDC), Dun and Bradstreet Number (DUNS), FDA Establishment Identification (FEI), and Global Trade Identification Number (GTIN) requirements
• Review and track requests for updates to Country Product Information (CPI) and CPI components. This includes QC, proofing, copy editing and formatting of documents, and coordinate review by Global Labeling Lead.
• Attend necessary labeling team meetings to discuss decisions regarding any label and CPI updates, discuss any findings of meaningful differences among Source Reference Labels (SRLs) and CPIs.
• Represent the Global Regulatory Services and Operations (GRSO), Global Labeling Group on project teams.
• Support the use and development of current and new tools, technologies, and processes to support global label development, submission, approval, and dispatch of Source Reference Labels in and to respective countries in addition to global label support.
• Track periodic CCDS reviews to ensure compliance with internal procedures and timelines.
• Maintain labeling history documents and assist in responding to labeling-related queries from various functional areas.
• Ensure all actions taken within role follow applicable SOPs and associated documents so that high quality delivery of outputs and compliance is maintained.
• Ensure appropriate tracking of labeling projects via defined procedures and optimal use of systems.
• Participate in and contribute to the continuous improvement efforts related to business practices and tools utilized within role.
• Contribute and support the development and maintenance of job aids and guidance documents.
• Support compliance activities including audits, inspections, and labeling-related escalations and non-conformances

Benefits

• Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://careers.eisai.com/us/en/compensation-and-benefits.
• Certain other benefits may be available for this position, please discuss any questions with your recruiter.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees