任职资格:

1.博士学位，专业方向包括（药物流行病学、流行病学、卫生/药物经济学、循证医学、公共卫生、临床药学、生物统计学或相关领域）；

2.具有较丰富的真实世界研究相关工作经验，能够独立牵头真实世界研究项目设计、实施与总结，具备创新药械真实世界研究项目经验者优先；

3.熟悉真实世界研究常用方法学，包括但不限于回顾性队列研究、前瞻性观察性研究、登记研究、数据库研究、药物经济学评价及卫生技术评估相关方法，具备较强的方法学判断和方案把关能力；

4.熟练掌握至少一种数据分析工具（R/Stata/SAS/Python），能够组织或指导医保、电子病历、随访、登记系统等多源异构数据的整理、分析与解释；

5.具有优秀的中英文写作与沟通能力，能够独立或指导撰写符合国家药监、医保、卫健等部门要求以及国际期刊标准的研究方案、统计分析计划、研究报告及政策建议材料；

6.深刻理解中国真实世界证据监管路径及应用场景，熟悉国家药监、国家医保、国家卫健等相关政策文件、技术指导原则及评价框架；

7.具有较强的项目管理能力、跨部门协调能力及对外合作能力，能够有效推动与医院、企业、科研机构及政府相关部门的沟通合作；

8.具备团队管理、人员带教或项目团队统筹经验者优先；

9.有参与卫生技术评估、医保支付、药品综合价值评估、监管沟通或政策研究经验者优先；

10.具有较强的责任心、执行力、组织协调能力和职业操守，认同中心发展目标，具备良好的创新意识与业务拓展意识。

Requirements:

1.PhD in Pharmacoepidemiology, Epidemiology, Health Economics/Pharmacoeconomics, Evidence-Based Medicine, Public Health, Clinical Pharmacy, Biostatistics, or related disciplines;

2.Substantial experience in real-world studies, with the ability to independently lead the design, implementation, and delivery of RWS projects; experience in RWS for innovative drugs or medical devices is strongly preferred;

3.Solid understanding of RWS methodologies, including retrospective cohort studies, prospective observational studies, registries, database studies, health economic evaluation, and HTA-related methods, with strong methodological judgment;

4.Proficiency in at least one analytical tool (R/Stata/SAS/Python), with the ability to organize or supervise the management and analysis of multi-source data, such as claims data, electronic medical records, follow-up data, and registry data;

5.Excellent Chinese and English writing and communication skills, with the ability to independently prepare or supervise study protocols, SAPs, study reports, and policy documents that meet the requirements of Chinese regulatory and reimbursement authorities as well as international journals;

6.In-depth understanding of China’s RWE regulatory pathways and use cases, with familiarity with policies, technical guidelines, and evaluation frameworks issued by the NMPA, NHSA, NHC, and related authorities;

7.Strong project management, cross-functional coordination, and external collaboration skills, with the ability to work effectively with hospitals, industry partners, research institutions, and government stakeholders;

8.Prior experience in team supervision, staff mentoring, or project team leadership is preferred;

9.Experience in HTA, reimbursement research, comprehensive value assessment, regulatory interaction, or health policy studies is preferred;

10.Strong sense of responsibility, execution ability, organizational skills, professional integrity, and alignment with the Center’s mission, with demonstrated innovation and business development awareness.

岗位职责:

1.负责中心真实世界研究业务的项目统筹与实施管理，围绕创新药品、医疗器械及相关卫生政策需求，组织开展真实世界研究，涵盖患者报告结局、安全性监测、有效性评价、药物/卫生经济学评价及综合价值评估等领域；

2.主导或统筹研究者发起及申办方发起的真实世界研究项目，负责研究方案设计、技术路线制定、实施推进、质量控制、成果产出及项目交付，确保研究符合科学、伦理及监管要求；

3.对接医疗机构、药械企业、政府部门及合作单位，推动真实世界研究项目立项、资源整合与落地实施，促进多方合作与外部拓展；

4.组织开展基于真实世界证据的医药产品综合价值评估工作，为医保目录调整、支付标准制定、卫生技术评估及相关政策研究提供技术支持；

5.负责高质量研究报告、技术文件、政策建议材料及学术成果的撰写、审核与把关，支持监管申报、医保准入、政策转化及学术传播；

6.跟踪国家及地方真实世界证据、药品器械审评审批、医保支付及卫生技术评估等相关政策动态，提出业务布局和研究方向建议；

7.参与团队建设与人才培养，指导团队成员开展方案设计、数据分析、报告撰写及项目管理工作；

8.完成领导交办的其他工作。

Key Responsibilities:

1.Lead the planning, coordination, and execution of real-world studies (RWS) at the Center, focusing on innovative pharmaceuticals, medical devices, and related health policy needs, including patient-reported outcomes (PROs), safety surveillance, effectiveness evaluation, health/pharmacoeconomic evaluation, and comprehensive value assessment;

2.Lead or oversee investigator-initiated and sponsor-initiated RWS projects, taking responsibility for study design, technical strategy, execution, quality control, deliverables, and final outputs, ensuring compliance with scientific, ethical, and regulatory requirements;

3.Engage with healthcare institutions, pharmaceutical/device companies, government agencies, and other partners to facilitate project initiation, resource integration, and implementation of RWS programs;

4.Organize and support comprehensive value assessment of medical products based on real-world evidence, contributing to reimbursement listing, payment standard setting, HTA, and related policy decision-making;

5.Prepare, review, and oversee high-quality study reports, technical documents, policy briefs, and academic outputs to support regulatory submissions, reimbursement access, policy translation, and scientific dissemination;

6.Monitor and interpret national and regional policy developments related to RWE, regulatory review and approval, reimbursement, and HTA, and provide recommendations on strategic business and research directions;

7.Contribute to team development and talent cultivation by mentoring junior staff in study design, data analysis, report writing, and project management;

8.Perform other duties assigned by leadership.

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