Senior Manager, Global Labeling
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. The Senior Manager, Global Labeling facilitates and leads the development, review, approval, and maintenance of the Company Core Data Sheets (CCDS) for assigned products and the Country Product Information (CPI) and CPI components for assigned products either globally as a Global Labeling Lead or regional/local as a Regional Labeling Lead. The Senior Manager, Global Labeling represents the Global Regulatory Network (GRN) Global Labeling Group on project teams and acts as a Subject Matter Expert (SME) on local, regional and multi-country regulatory labeling requirements and participate in the sharing of intelligence. The Senior Manager, Global Labeling follows Global Labeling procedures and maintains relevant databases and document management systems for assigned products.
Requirements
- Minimum BS degree or higher in life science.
- 8+ years of experience in drug development environment, with minimum 3-5 years of regulatory experience within the pharmaceutical industry.
- Experience in global and/or local regulatory labeling environments is preferred.
- Demonstrate a solid working knowledge of drug development process, as well as FDA and EU labeling; knowledge of and experience with Asia and other markets labeling desirable.
- Competent knowledge of and demonstrated ability to apply regulatory guidelines pertaining to product labeling and ICH guidelines.
- Demonstrate strong project management, people management, problem solving, strategic thinking, negotiation, interpersonal and communication skills (both written and oral) attention to detail and ability to work under tight timelines.
Responsibilities
- Coordinate and lead cross-functional teams in the development and lifetime maintenance of the TPP, CCDS and Country Product Information (CPI) and CPI components for assigned products/projects. This includes QC, proofing, copy editing and formatting of documents, and coordinate review and approval of final submission.
- Provide tactical and strategic guidance to CPI development teams regarding regulatory requirements, content and design for TPP, CCDS, CPI and CPI components for assigned products on a global basis.
- Manage direct reports.
- Coordinate Content of Labeling/Drug Listing SPL generation and review to ensure compliance with US CPI regulations.
- Maintain labeling history documents and assist in responding to labeling-related queries from various functional areas. Maintain expertise regarding key labeling requirements worldwide and stay current with labeling guidelines and regulations on a global basis.
- Participate or lead special assignments related to GRN, GL or other cross-functional processes and/or activities.
Benefits
- Annual Incentive Plan
- Company employee benefit programs
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What This Job Offers
Job Type
Full-time
Career Level
Senior
