ob Purpose职位设置目的 Support Surgery BU ISS program and Tissuepatch PMS study, act as liaison among investigators, BD internal stakeholders and 3rd party vendors as needed, assist processes and ensure clinical project execution on time, with good compliance, budget & quality control. 支持外科 BU ISS 计划和 Tissuepatch PMS 研究，根据需要担任研究人员、BD 内部利益相关者和第三方供应商之间的联络人，协助流程并确保临床项目按时执行，同时遵守良好的合规性、预算和质量控制。 Key Responsibility主要职责 1. Provide clinical expertise and insight in medical strategy and planning phase and evidence generation activities 2. Provide scientific input and medical review to promotional material development 3. Supports Clinical Project Manager in ensuring GCP compliance throughout clinical trial planning and execution 4. Prepares, reviews, and/or supports generation of clinical/medical documents needed for regulatory submissions to ensure adequacy of support for all claims pertaining to the safety, effectiveness, and clinical performance of all products 5. Communication with key stakeholders and participate in regular project meetings to provide timely update 6. Reviews proposals for ISS (Investigator-Sponsored Studies) as requested 7. Represents MA to professional societies and at medical and scientific meetings and seminars 8. Keeps up to date with literature and trends in health care delivery, diagnosis, and treatment of human disease, especially as these relate to the BU’s product portfolio 9. Maintain professional relationships with clinical investigators (KOLs) and supports advisory boards as required 10. Provide assistance in the clinical trial internal processes as needed, such vendor bidding, contract, payment and invoice, etc. 1. 在医疗战略和规划阶段以及证据生成活动中提供临床专业知识和见解 2. 为宣传材料的编写提供科学意见和医学审查 3. 协助临床项目经理确保在整个临床试验规划和执行过程中符合 GCP 要求 4. 4. 4. 准备、审查和/或支持生成监管呈件所需的临床/医学文件，确保所有产品的安全性、有效性和临床表现方面的所有声明都得到充分支持 5. 与主要利益相关者沟通，参加定期项目会议，及时提供最新情况 6. 根据要求审查 ISS（研究者赞助的研究）提案 7. 代表 MA 参加专业协会、医学和科学会议及研讨会 8. 随时了解医疗保健服务、人类疾病诊断和治疗方面的最新文献和趋势，特别是与业务单位产品组合相关的文献和趋势 9. 与临床研究人员（KOL）保持专业关系，并根据需要支持咨询委员会的工作 10. 根据需要协助临床试验内部流程，如供应商招标、合同、付款和发票等。 Key Measurable关键指标 1. Clinical strategy and plan meet business and regulatory needs and requirements 2. On-time deliver promotional material, protocol/report review work and meet scientific and regulatory requirements 3. Effective and timely stakeholder communication GCP and medical compliance assurance 1. 临床战略和计划符合业务和监管的需要和要求 2. 按时交付宣传材料、方案/报告审查工作，满足科学和监管要求 3. 3. 有效、及时地与利益相关者沟通 4. GCP 和医疗合规保证

Selection Criteria/Education/Experience & Competency任职资格/教育/经验和能力要求 1. Bachelor degree of Clinical Medicine, clinical training and practice in neurosurgery, thoracic surgery, general surgery, orthopedics preferred 2. At least 2-year experience in medical affairs role in MNC companies, with at least 1-year clinical research experience, clinical operation and project management experience is preferred 3. Good knowledge of the NMPA regulations, ICH-GCP, GCP(NMPA) 4. Good knowledge of clinical trial methodology, study design and implementation, as well as study data analysis and interpretation 5. Good planning, organizing, teamwork and communication skills 6. Fluent in both spoken and written English 1. 临床医学学士学位，接受过神经外科、胸外科、普外科、骨科临床培训和实践者优先考虑 2. 至少 2 年跨国公司医疗事务工作经验，至少 1 年临床研究经验，有临床运营和项目管理经验者优先考虑 3. 熟悉 NMPA 法规、ICH-GCP、GCP（NMPA） 4. 4. 熟悉临床试验方法、研究设计和实施，以及研究数据分析和解释 5. 良好的计划、组织、团队合作和沟通能力 6. 6. 英语口语和写作流利