Summary
About the Role
~ 管理中小型全球监管提交项目。
~ 为开发、注册和维护全球产品所需的技术相关监管战略、情报和知识提供提交和贡献。
~ 促进战略和技术投入/支持，推动全球系统、工具和流程的实施，以支持全球发展项目和/或营销产品。
~ 频繁的内部公司和外部联系人。代表特定项目的组织
~ 在分析情况或数据需要审查各种因素的情况下，对中等范围的问题进行工作。
~ 在收到诺华产品后24小时内报告与诺华产品相关的技术投诉/不良事件/特殊情况
~ 营销样本的分发（如适用）
Key Performance Indicators
确保受控的文档系统、记录保留和信息服务，包括符合法规要求的电子记录保留流程。确保符合监管机构的要求。维护技术和非技术文档更改系统。确保程序到位，以分类和维护记录。解释和执行所有文档格式，标准，政策和操作程序要求。可以识别提交组件，传达文档标准并协调监管档案的汇编。可以分析和评估数据，提取相关信息，准备信息摘要和所搜索材料的执行摘要。可以保持对产品信息的广泛了解，并与当地，区域和部门客户保持持续联系。
Work Experience
~运营管理和执行
~项目管理
~跨界协作
~职能广度
~跨文化经历
Skills
~生命科学
~临床研究报告
~法规遵从性
~文档管理
~卓越运营
~数据分析
Language
英语
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
