全球标签经理
Senior Manager, Global Labeling
在艾利西，满足未被满足的医疗需求，并提升医疗对患者、其家人和照护者的益处是艾利西的人类健康护理（HHC）使命。我们是一家正在神经科学和肿瘤学领域取得突破的快速发展的制药公司，高度重视研发。我们的历史包括许多创新药物的开发，特别是阿尔茨海默病最广泛使用的治疗方法的发现。随着持续扩展，我们正在寻找希望在快节奏环境中工作并产生影响的高积极性人才。如果你符合这个条件，我们期待你的加入。
高级经理，全球标签负责推动并领导指定产品的公司核心数据表（CCDS）以及国家产品信息（CPI）及其组件的开发、审查、批准和维护工作，作为全球标签负责人在全球范围内或作为区域标签负责人在区域/本地范围内进行操作。高级经理，全球标签代表全球监管网络（GRN）全球标签小组参与项目团队，并作为本地、区域和多国监管标签要求的专家（SME），参与情报共享。高级经理，全球标签遵循全球标签流程，并为指定产品维护相关数据库和文档管理系统。
主要职责
- 协调并领导跨职能团队，负责指定产品/项目的 TPP、CCDS 和国家产品信息（CPI）及其组件的开发和全生命周期维护。这包括文件的质量控制、校对、文字编辑和格式化，以及协调最终提交的审查和批准。30%
- 为 CPI 开发团队提供关于全球范围内指定产品的 TPP、CCDS、CPI 及其组件的监管要求、内容和设计方面的战术和战略指导。25%
- 管理直接下属。10%
- 协调标签/药品清单 SPL 的生成和审查，确保符合美国 CPI 法规。10%
- 维护标签历史文件，并协助回应来自不同职能部门的标签相关查询。保持对全球关键标签要求的专业知识，并在全球范围内及时了解标签指南和法规。15%
- 参与或领导与 GRN、GL 或其他跨职能相关的特别任务。
查看英文原文
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.Essential Functions
- 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. 30%
- 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. 25%
- Manage direct reports. 10%
- Coordinate Content of Labeling/Drug Listing SPL generation and review to ensure compliance with US CPI regulations. 10%
- 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. 15%
- Participate or lead special assignments related to GRN, GL or other cross-functional processes and/or activities. 10%
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.
Eisai Salary Transparency Language:
The annual base salary range for the Senior Manager, Global Labeling is from :$129,000-$169,300Under 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 .
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:
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Originally posted on Himalayas