AR Specialist Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate
When our values align, theres no limit to what we can achieve. At Parexel, we all share the same goal - to improve the worlds health. From clinical trials to regulatory, consulting, and market access, every
Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich
Mgr, Corp Comp & Ethics - Shanghai Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum,
Job Description SummaryGE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are,
SMA in RWLP- Guangzhou, China, home-based Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping
CRA I - Guangzhou Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate
Job Summary Job Description Job Responsibilities • •Act as site Subject Matter Expert (SME) for validation of equipment, sterile packaging, mixing, water systems (PW/WFI, distribution loops), filling systems (aseptic and non-aseptic), cleaning processes (CIP/COP, manual cleaning
INTRODUCTORY PARAGRAPH Evinova is a health-tech business, accelerating the delivery of better health outcomes by propelling the life sciences sector forward in digital health, from the inside. Evinova delivers proven outcomes for sponsors, sites, and patients,
China-Principal Clinical Data Standards Consultant ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and
About Us: Structure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design
Project Manager II/ Senior Project Manager (Early phase experience required) Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development
Sr CRA I - Guangzhou Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them
CRA II - Beijing Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate
中国，上海 | 全职 | Job ID: 11620 Position Summary: Supports clinical operational effectiveness, training enablement, vendor management and serves as a key coordination point with QA for China Clinical Operations. Works closely with study teams to
CRA I - Beijing Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate
CRAI Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change
医疗注册实习生 深圳 校招 实习 智能制造 / 工业互联网 / 工业自动化 职位描述 安克实习生项目是面向正式校招岗位的人才培养与选拔通道。实习期间将按照校招标准进行系统的培养与综合评估，表现优秀者可直接获得校招转正机会，提前锁定正式校招席位。我们以严肃、长期的视角对待每一位实习生，也期待与你共同成长。【你将参与】1. 协助医疗器械产品在全球主要市场的注册申报工作，协调推进FDA、欧盟MDR及中国NMPA等法规体系下的准入流程；2. 编写和审核注册所需的技术文件，确保资料符合各国监管要求并具备高质量交付能力；3. 协助对接监管机构、公告机构及第三方服务机构，推动审评问题的答复与闭环；4. 参与产品研发全过程，确保设计开发活动满足医疗器械质量管理体系的合规要求；5. 协调跨部门资源，推动注册项目按计划高效推进，保障产品顺利上市。 职位要求 1. 本科以上学历，通信类、电子类、化学类、生物医药、临床医学/技术英语等理工科专业，具备基础英语沟通能力；2.具备医疗器械相关领域基础知识，了解有源类或无源类医疗器械的法规注册流程；3. 协助完成注册资料的编制与管理，具备良好的技术文档撰写与文字整合能力；4. 具备较强的沟通协调能力，能够有效联动研发、质量、生产等多职能团队；5. 性格开朗活泼，工作严谨细致，具备较强的责任心和抗压能力。 投递...
医疗质量体系实习生 深圳 校招 实习 智能制造 / 工业互联网 / 工业自动化 职位描述 安克实习生项目是面向正式校招岗位的人才培养与选拔通道。实习期间将按照校招标准进行系统的培养与综合评估，表现优秀者可直接获得校招转正机会，提前锁定正式校招席位。我们以严肃、长期的视角对待每一位实习生，也期待与你共同成长。【你将参与】1.体系策略 - 根据公司产品策略，协助完成产品全球市场准入工作（中国NMPA﹑美国FDA、欧盟CE-MDR等）的体系策划、组织和实施，制定产品体系审核策略；2.体系认证 - 依据ISO13485，QS820和GMP的要求，结合IPD和PLM流程，协同研发编制DHF，DMR等体系文件，对产品相关的体系文件交付质量负责； 参与委托生产的设计转换工作，协助优化代工厂医疗器械生产质量体系，保证DHR文档真实，可追溯；3.合规监管 - 协助与监管部门对接，处理各类事宜，积极完成相关监管任务；4.合规维护 - 协助产品认证有效性维护和全生命周期的合规控制，参与设计变更对认证合规影响的评审并制定应对方案。负责法规的收集、解读及研究跟踪法规和标准变化趋势，及时组织内部切换，督促研发更改完善已上市产品的法规符合性；5.合规意识 - 协助公司内部法规意识的建立，并根据需要举行法规知识培训；6.协助编制修订体系文件和相关审核认证工作。 职位要求 1.硕士及以上学历，通信类、电子类、化学类、生物医药、临床医学/技术英语等理工科专业，具备基础英语沟通能力；2.了解有源器械中国NMPA，欧盟CE MDR或美国FDA等主流国家注册流程；3.了解《医疗器械生产质量管理规范》、ISO13485、MDSAP、FDA QSR820等质量体系要求；4.条理清晰、逻辑思维缜密、性格开朗活泼，具有良好的沟通协调能力，团队协作能力。 投递...