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. 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. Essential Functions 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 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 Eisai Salary Transparency Language: The annual base salary range for the Manager, Global Labeling is from :$102,300-$134,300 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. 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. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation