Career CategoryRegulatory Job Description Job Description Apply, obtain and maintain regulatory approvals for products within Amgen’s portfolio, including CTNs, MAAs, renewals, variations, and other life cycle management activities. Ensure all regulatory submissions are delivered on time
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
• Supports country SSU strategy in close collaboration with the SSO Study Start-Up Team Lead and the SSO Study Start-Up Managers to ensure SSU timelines and deliverables are met according to country commitments • Accountable for
Work ScheduleStandard Office Hours (40/wk) Environmental ConditionsOffice Job Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life -
Work ScheduleStandard Office Hours (40/wk) Environmental ConditionsOffice Job Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life -
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
About the position Support the “Integrated Marketing Lead” in short/long term MKT strategic planning & campaign executions thru consumer journey from building brand awareness, likeness haloing Novo Nordisk core brand essence (e.g. Semaglutide as Originator) &
Main Responsibilities • Accountable for managing overall study timelines, budgets and quality targets • Accountable for building, forecasting and managing the Clinical Trial Budget • Leads the China core study team; manages, facilitates and documents core
About Human Pharmaceutical Business With global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of
主要职责 1.根据试验方案、合同规定的工作范围、SOP和GCP的要求，协助CRA在研究中心进行简单的核查工作。 2.协助CRA进行临床研究相关的文件整理工作。 3. 完成直线经理和/或项目经理（PM）分配的其他工作。 任职要求 1.27届及以上在校生本科或硕士，医药相关专业优先，英语四级或以上。 2.表现优异并能够长期实习。 3.对临床研究和CRA有一定的了解。 4.每周可实习3天或以上（周一至周五），要求可尽快入职并能够至少实习3个月或以上。 IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to
Responsibilities: Supports country SSU strategy in close collaboration with SSO Study Start-Up Team Lead and SSO Study Start-Up Managers to ensure SSU timelines and deliverables are met according to county commitments. Responsible for accounting and execution
Job Overview: Site monitoring and site management responsibility for clinical studies according to Company, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. Assures the implementation of project plans, as assigned. Summary of Responsibilities: Responsible for all
职位概要 作为研究中心研究者团队的成员，在研究中心遵照研究方案、商定的工作范围、GCP、申办者/公 司SOP及其他相关指南和法规的要求，来协调和执行所分配的临床试验。 职责 • 作为研究团队成员，遵照法规要求、商定的工作范围、适用的SOP、工作授权和试验方案，在 研究中心进行工作。 • 协助研究者完成可行性调查问卷和回收问卷。 • 推动研究中心启动工作：协助研究中心筛选访视，协助及时提交文件到伦理委员会进行审批 和试验用药品的发放，协助研究中心启动访视。 • 协助研究者进行受试者筛选和入组研究。 • 得到研究者授权后，根据法规和GCP的要求，协助研究者顺利完成方案要求的随访和步骤：如 制定计划、清点核对药品和其他协调工作。 • 在研究中心协助研究者管理试验用药品、研究物资和实验室样本。 • 在商定的工作范围内，参加研究者会、监查访视、稽查和其他会议。 • 协助研究者归档研究资料，并提交至伦理委员会或其他权威机构。 • 准确地将原始文件中的数据填写到病例报告表，并协助query的解答。 • 推动研究中心关闭：协助研究中心关闭访视、试验用药品和研究资料的回收，以及研究资料 的归档。 • 创建和维护日常工作报告和其他工作文件。 • 根据工作需要，可能需要不定时出差或暂时借调至其他城市。 • 完成分配的其他任务。 所需知识、技能和能力 • 了解临床研究的基本知识和适用的法规要求。 •
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,
Company Description About AbbVie AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on
Company Description About AbbVie AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on
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
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
Job Overview: The Clinical Trial Manager I has ownership in the clinical delivery and operational oversight of clinical research trials. This role collaborates with project managers and other functional leads to deliver clinical and start-up activities