岗位职责和要求
根据总部与公司业务发展策略以及临床营养发展的最新进展，制定产品注册相关临床试验策略与行动计划，并指导与协调相关职能团队开展并执行。
Develop clinical trial strategies and action plans for product registration based on global and company business strategies as well as the latest developments in clinical nutrition; provide guidance and coordination to relevant functional teams for effective implementation.
全方位了解药品与特医临床试验相关法律/法规以及GCP，收集有关行业发展动态。
Maintain a comprehensive understanding of laws, regulations, and GCP related to pharmaceutical and FSMP clinical trials; monitor industry trends and regulatory updates
建立并维护与国内知名临床专家与营养专家之间的紧密与良好的关系；了解并掌握营养发展的最新进展；前瞻性参与临床治疗/营养支持有关的指导原则与共识的讨论与制定。
Establish and maintain strong relationships with leading clinical and nutrition experts in China; stay informed of the latest advancements in nutrition; proactively participate in the development and discussion of clinical treatment and nutrition support guidelines and consensus.
负责新产品注册临床试验项目，包括方案的准备，相关临床数据的分析与汇总、临床总结报告撰写等，并根据GCP与其他法规要求指导相关临床试验高质量的开展与执行。
Take charge of new product registration clinical trial projects, including protocol development, clinical data analysis and summarization, and clinical study report writing; ensure high-quality execution of trials in compliance with GCP and other regulatory requirements.
负责管理《合同研究组织/CRO》承担的临床试验项目（包括：GCP与法规符合性，临床试验进度，试验的质量，报告的撰写以及费用管理），并确保注册性C.T. 通过官方对医院的现场核查和评审。
Manage clinical trial projects conducted by Contract Research Organizations (CROs), covering GCP and regulatory compliance, trial progress, quality, reporting, and budget control; ensure registration trials pass on-site inspections and evaluations by regulatory authorities.
负责药物警戒和医疗器械警戒体系的有效运行和维护，监测、识别、评估和控制药品不良反应及医疗器械不良事件等。
Ensure the effective operation and maintenance of pharmacovigilance and medical device vigilance systems, including the monitoring, identification, evaluation, and control of adverse drug reactions and adverse events related to medical devices.
开展药物警戒和医疗器械警戒的培训，制定培训计划，按计划开展培训并评估培训效果。
Organize and deliver training on pharmacovigilance and medical device vigilance; develop training plans, conduct sessions as scheduled, and evaluate training effectiveness.
Qualifications, Knowledge & Skills Required岗位任职要求
| 1. 临床医学或与之相关的预防医学以及营养医学研究生以上学历 Master’s degree or above in clinical medicine, preventive medicine, or nutritional medicine. |
| 2． 至少10年以上医院临床、药品注册相关工作经验，具有良好的临床营养专业知识 Minimum of 10 years of experience in hospital clinical practice or pharmaceutical registration, with solid expertise in clinical nutrition. |
| 3．熟悉GCP、药品注册、药物警戒、医疗器械警戒等相关法律法规 Familiar with GCP and relevant laws and regulations related to drug registration, pharmacovigilance, and medical device vigilance. |
| 4. 流利的英语口语、听力和医学写作能力 Fluent in spoken and written English, with strong medical writing skills. |
| 5. 具有很强的团队合作精神，且具有正面积极工作态度以及很强的组织协调能力和沟通技巧 Strong team spirit, proactive and positive work attitude, with excellent organizational and communication skills. |
| 6．善于开动脑筋，工作仔细认真负责，并能吃苦耐劳，有进取性，能够出差。 Creative and detail-oriented, responsible and resilient, with a strong sense of initiative and willingness to travel. |
