1 INTRODUCTION
粵港澳大灣區國際臨床試驗中心（以下簡稱“中心”）是由深圳醫學科學院計劃建設的面向粵港澳大灣區、具有全球影響力的臨床試驗公共服務平臺。
The Greater Bay Area International Clinical Trials Center (hereinafter referred to as “the Center”) is a public clinical trial service platform with global impact, established by the Shenzhen Medical Academy of Research and Translation (SMART).
粵港澳大灣區國際臨床試驗中心是貫徹落實《國務院關于印發〈河套深港科技創新合作區深圳園區發展規劃〉的通知》（國發〔2023〕12號）的重要舉措，是支持深圳建設國際科技創新中心和推進粵港澳大灣區生物醫藥產業高質量發展的有力支撐。中心將落戶河套深港合作區，通過充分發揮河套獨特的區位優勢和不斷疊加的政策優勢，鏈接粵港澳大灣區臨床創新資源，深化深港科技合作，搭建一站式臨床試驗平臺，為國際國內藥械研發機構提供一流臨床試驗技術支撐與運營管理服務。同時，中心還將發揮臨床試驗政策規則體系改革的“頭雁”作用，推進臨床試驗規則和標準與國際對接，助力構建粵港澳大灣區醫學科技創新聯合體，提升區域生物醫藥產業發展競爭力。
The Center’s establishment is a key
initiative aimed at implementing the "Development Plan for the
Shenzhen-Hong Kong Science and Technology Innovation Cooperation Zone",
issued by the State Council (State Document No. [2023] 12). It represents a
crucial step in supporting Shenzhen’s efforts to become an international hub
for scientific and technological innovation. It is integral to promoting the
high-quality growth of the biopharmaceutical industry in the Greater Bay Area.
The Center will be strategically located in the Hetao Shenzhen-Hong Kong
Cooperation Zone, leveraging the area’s unique geographical and policy
advantages. By connecting clinical innovation resources from across the Greater
Bay Area and fostering deeper collaboration between Shenzhen and
中心建設初期，設置機構服務及行政辦公室、方案開發與方法學部、項目運營與質量管理部、數據技術部、政策法規辦公室五個主要部門，承擔臨床研究服務、統籌臨床研究資源、提升區域臨床研究能力、創新臨床研究機制、開展國際交流與合作等職能。現根據中心組建和運行工作需要，深圳醫學科學院面向社會誠招臨床方案開發、臨床項目運營、數據技術管理等各類人才若干名。具體崗位和招聘條件如下：
In initial phase, the Center will establish five core departments: the Institutional Services and Administrative Office, the Program Development and Methodology Department, the Project Operations and Quality Management Department, the Data and Technology Department, and the Regulatory Affairs Office. These departments will be responsible for providing clinical research services, coordinating research resources, enhancing regional research capabilities, fostering innovation in clinical research, and promoting international cooperation and communication. According to the needs of the Center's construction and operations, SMART is now sincerely recruiting professionals for a variety of employment, including clinical program development, project operations, and data technology. The specific job openings and qualifications are as follows. Specific positions and recruitment conditions are as follows:
2 JOB DESCRIPTION
高管
Executive
Deputy Director (Operations)
1 position available
Location: The Greater Bay Area International Clinical Trials Centre, Shenzhen, PRC
Job Description:
We are hiring a experienced Deputy Director (Operations) to lead the strategic direction and day-to-day operations of our world-class clinical trials center.
The Operations Director will optimize resources, manage finances, and drive international branding and partnerships
This role will play a pivotal role in shaping the future of the center by fostering collaboration and integrating clinical research resources in the Greater Bay Area.
Key Responsibilities:
1. Develop and execute the center's operational strategy to achieve its short, medium, and long-term goals.
2. Manage daily operations, improve efficiency, and optimize resource allocation.
3. Oversee financial management, including budgeting, risk control, and transparency.
4. Lead marketing and branding initiatives to enhance the center’s international reputation.
5. Foster international partnerships with government, academic, medical, and industry organizations.
Requirements:
1. 15+ years of management experience in the bio-pharmaceutical or CRO industry with a deep understanding of clinical trials and pharmaceutical R&D processes.15+ years of management experience in the bio-pharmaceutical or CRO industry with a deep understanding of clinical trials and pharmaceutical R&D processes.
2. Strong leadership, project management, and communication skills.
3. Master’s degree in MBA or a related management field (preferably from a globally recognized institution).
4. Familiar with both domestic and international regulations governing pharmaceuticals and medical devices.
5. Proficient in English with strong cross-cultural communication skills.
6. The conditions of employment may be appropriately relaxed for those who are particularly outstanding.
副主任（技術） 1人
崗位職責
1. 技術平臺與管理體系建設：規劃和管理中心的臨床試驗技術和信息化支持平臺，建立高效的技術服務流程和質量管理體系；
2. 技術服務與支持：提供策略咨詢與預評估服務，支持合同研究服務，確保項目的技術可行性；
3. 創新與優化：開發創新的藥械臨床試驗工具，建設試驗參與者準備隊列，推動倫理審查優化和新型臨床試驗設計，提升研究效率和質量；
4. 人才培養與培訓：協助中心主任建設臨床研究培訓平臺，為區域內培養具有國際視野和高水平研究能力的領軍人才與科研隊伍；
5. 團隊領導與發展：協助中心主任領導多學科臨床試驗技術團隊，確保服務符合國際標準，推動臨床研究能力提升；
6. 完成中心主任交辦的其他事項。
任職要求
1. 專業經驗：擁有15年臨床試驗領域的技術從業經驗，且具備豐富的技術管理經驗；
2. 領導能力：優秀的團隊領導和項目管理能力，能有效帶領技術團隊完成跨區域復雜項目；
3. 教育背景：醫學或藥學博士學歷，有國外求學研究經歷者優先；
4. 政策法規：熟悉國際臨床試驗標準和法規，具有推動技術創新和轉化應用的成功案例者優先；
5. 行業視野：具備國際視野和經驗，熟悉藥械研發行業動態和技術趨勢；
6. 語言能力：出色的英語技能，具備優秀的跨文化交流能力；
7. 特別優秀者，可適當放寬任職條件。
Deputy Director (Technical)
1 position available
Location: The Greater Bay Area International Clinical Trials Centre, Shenzhen, PRC
Job Description:
We are hiring an experienced Deputy Director (Technical) to oversee the development of the center’s clinical trial technology and IT platforms.
The Technical Director will ensure the implementation of high-quality technical services and innovative tools for clinical trials.
This role will also play a crucial part in training future leaders and building a multidisciplinary technical team.
Key Responsibilities:
1. Plan and manage the technical platform and information systems for clinical trials.
2. Provide strategic consulting, technical support, and ensure the feasibility of research projects.
3. Lead the development of innovative tools for clinical trials and optimize research design.
4. Foster and lead a high-performing technical team, ensuring adherence to international standards.
Requirements:
1. 15+ years of technical experience in clinical trials and technical management, with the ability of leading cross-regional complex projects.
2. PhD in Medicine or Pharmacy, with international study or research experience is preferred.
3. Familiar with international clinical trial standards and regulations.
4. Proficient in English with strong leadership and cross-cultural communication skills.
5. The conditions of employment may be appropriately relaxed for those who are particularly outstanding.
機構服務及行政辦公室
Institutional Services and Administrative Office
行政服務辦公室總監 1人
崗位職責
1. 負責行政管理體系的建立、維護和優化，參與制定行政管理政策和流程，并監督執行；
2. 組織和協調中心行政相關會議和活動，確保順利進行；負責組織各類培訓活動和人才培養項目；
3. 建設和管理行政團隊，提升團隊的專業能力和工作效率；
4. 與外部機構建立和維護良好的關系，處理相關行政事務；
5. 完成上級交辦的其他工作。
任職要求
1. 專業經驗：具有10年大型企業或醫藥行業的行政管理經驗，有行政總監或相當職位的工作經驗者優先；
2. 領導能力：具備優秀的團隊管理、領導和組織協調能力，具備解決復雜問題的能力，能夠帶領行政團隊高效完成工作；
3. 教育背景；碩士以上學歷，行政管理、人力資源管理、工商管理或相關專業者優先；
4. 語言能力：具備在英文環境下勝任崗位職責的能力。
5. 特別優秀者，可適當放寬任職條件。
Director of Administrative Services
1 position available
Location: The Greater Bay Area International Clinical Trials Centre, Shenzhen, PRC
Job Description:
We are hiring a Director of Administrative Services to establish and optimize the center’s administrative systems.
The Director of Administrative Services involves organizing key events and meetings, leading the administrative team, and maintaining relationships with external agencies.
This role will play a crucial role in ensuring operational efficiency and supporting talent development within the Center.
Key Responsibilities:
1. Establish, maintain, and optimize the administrative management system.
2. Organize and coordinate administrative meetings, events, and training programs.
3. Lead and develop the administrative team to enhance professional skills and efficiency.
4. Build and maintain strong relationships with external agencies and handle administrative tasks.
Requirements:
1. 10+ years of experience in administrative roles, preferably in large enterprises or the pharmaceutical industry.
2. Strong team leadership, problem-solving, and organizational skills.
3. Master’s degree in Administration, Human Resource Management, Business Administration or related fields.
4. Fluent in English with the ability to perform effectively in an English-speaking environment.
5. The conditions of employment may be appropriately relaxed for those who are particularly outstanding.
方案開發與方法學部
Program Development and Methodology Department
方案開發與方法學部總監 1人
崗位職責
1. 根據中心總體規劃目標，組建方案開發與方法學平臺，并組織開展業務工作；
2. 負責組織制定中心方案開發與生物統計業務工作制度、規章、操作標準等規范，并監督實施；
3. 組織對部門人員進行專業培訓、指導與考核，參與部門人員招聘；
4. 負責組織部門開展與臨床試驗項目方案開發、統計分析工作，并在計劃時間內高質量地完成；
5. 負責組織建立、維護與相關專業領域專家的良好關系，就方案開發與統計分析中遇到的專業問題與專家進行溝通咨詢；
6. 負責就部門業務與中心其他相關部門進行溝通和協調，組織部門對中心其他部門提供及時、高效的技術支持；
7. 完成上級交辦的其他工作。
任職要求
1. 專業經驗：具有在生物醫藥或CRO行業10年項目開發或方法學平臺工作經驗，3年部門管理的工作經驗，精通臨床試驗設計；
2. 領導能力：具有出色的領導和執行力，以及優秀的溝通、培訓和演講技能；
3. 教育背景：醫學或藥學博士學歷；
4. 政策法規：熟悉國內國際藥械監管的法律法規和產業政策；
5. 行業視野：熟悉國內外藥物研究發展和現狀；
6. 語言能力：具備在英語環境下勝任崗位職責的能力；
7. 特別優秀者，可適當放寬任職條件。
Director of Program Development & Methodology
1 position available
Location: The Greater Bay Area International Clinical Trials Centre, Shenzhen, PRC
Job Description:
We are hiring a Director of Program Development & Methodology to build and lead the program development and methodology platform for the Center.
This role will involve overseeing clinical trial design, statistical analysis, and ensuring timely and high-quality project execution.
Key Responsibilities:
1. Establish and manage the program development and methodology platform.
2. Develop and implement regulatory and operational standards for program development and bio-statistics.
3. Lead training, recruitment, and assessment of departmental personnel.
4. Oversee clinical trial protocol development and statistical analysis.
5. Maintain relationships with industry experts to address complex project issues.
Requirements:
1. 10+ years of experience in project development or methodology within the bio-pharmaceutical or CRO industry.
2. Strong leadership and execution skills, with excellent communication and presentation abilities.
3. PhD in Medicine or Pharmacy.
4. Familiar with domestic and international regulations governing drug and device development.
5. Fluent in English with the ability to perform duties in an English-speaking environment.
6. The conditions of employment may be appropriately relaxed for those who are particularly outstanding.
統計師 若干人
崗位職責
1. 負責制定臨床研究統計計劃，完成臨床試驗方案中的統計部份設計，包括樣本量計算、隨機和編盲、統計分析計劃等；
2. 參與方案討論會，并提供統計支持；
3. 臨床數據統計分析與報告審核；
4. 臨床研究統計部分供應商管理，審核或獨立撰寫統計分析計劃，可獨立進行研究數據的資料處理和統計分析；
5. 能在工作中使用SAS等軟件進行統計分析程序編寫，進行一定的數據挖掘和分析；
6. 能參與學術交流及藥物審評討論。
任職要求
1. 教育背景：碩士及以上學歷，生物統計、醫學統計等相關專業；
2. 工作經驗：獨立完成過臨床數據收集、整理、挖掘分析工作；熟悉臨床試驗設計與統計分析流程，2年以上相關經驗；
3. 專業技能：熟悉國內外臨床試驗相關的生物統計學技術指導原則，熟練運用臨床試驗常規統計軟件；
4. 其他條件：有較強的邏輯性、強烈的團隊合作意識與責任感，有較強的英文閱讀原文和寫作的能力。
Bio-statistician
Multiple positions available
Location: The Greater Bay Area International Clinical Trials Centre, Shenzhen, PRC
Job Description:
We are hiring Bio-statisticians to design and manage statistical plans for clinical research projects.
This role will contribute to the development of clinical trial protocols, provide statistical analysis, and manage vendor relationships.
Key Responsibilities:
1. Develop and execute statistical plans for clinical trials, including sample size calculation, randomization, and blinding.
2. Provide statistical support during protocol discussions and meetings.
3. Conduct data analysis and review statistical reports.
4. Manage and oversee vendors handling statistical portions of clinical trials.
5. Utilize statistical software (e.g. SAS) for data mining, analysis, and reporting.
Requirements:
1. Education: Master’s degree or above in Bio-statistics, Medical Statistics or related fields.
2. Experience: 2+ years of experience in clinical trial design and statistical analysis.
3. Skills: Proficient in using statistical software and familiar with domestic and international biostatistical technical guidelines related to clinical trials. With strong logic and responsibility in work.
4. Language: Fluent in English
項目運營與質量管理部
Project Operations and Quality Management Department
項目運營與質量管理部總監 1人
崗位職責
1. 根據中心總體規劃目標，組建項目運營與質量管理部門，并組織開展業務工作；
2. 負責組織制定中心臨床運營、項目管理、臨床監察、質量保證和質量控制等臨床研究實施各環節的工作制度、規章、操作標準等規范，并監督實施；
3. 組織對部門人員進行專業培訓、指導與考核，參與部門人員招聘；
4. 協調與各臨床研究中心的合作關系，保持與各中心的主要研者進行良性的互動；與涉及的藥政法規監管部門，醫學領域專家、科研院所等相關部門，建立并保持交流和溝通的渠道；
5. 完成上級交辦的其他工作。
任職要求
1. 專業經驗：在制藥企業或臨床CRO公司至少10年臨床運營、臨床監察或相關工作經驗，3年部門管理的工作經驗，廣泛的醫院網絡資源，熟悉臨床試驗運營；
2. 教育背景：臨床醫學、臨床藥學、藥事管理等相關專業碩士或以上學歷；
3. 政策法規：熟悉國內國際藥械監管的法律法規，及臨床試驗流程；
4. 語言能力：具備在英語環境下勝任崗位職責的能力；
5. 特別優秀者，可適當放寬任職條件。
Director of Project Operations & Quality Management
1 position available
Location: The Greater Bay Area International Clinical Trials Centre, Shenzhen, PRC
Job Description:
We are hiring a Director of Project Operations & Quality Management to establish and lead the project operations and quality management department.
This role will oversee clinical trial operations, ensure compliance with quality standards, and foster relationships with clinical research centers and regulatory bodies.
Key Responsibilities:
1. Develop and lead the Project Operations & Quality Management Department.
2. Formulate and implement regulations, operation standards, and quality assurance processes for clinical research.
3. Provide training and guidance for the department’s personnel and lead recruitment efforts.
4. Build strong collaborative relationships with clinical research centers, regulatory bodies, and industry experts.
Requirements:
1. 10+ years of experience in clinical operations or monitoring within pharmaceutical companies or CROs.
2. 3+ years of experience in departmental management with strong hospital network resources.
3. Master’s degree or above in Clinical Medicine, Clinical Pharmacy, or related fields.
4. Familiar with both domestic and international regulations governing clinical trials and drugs/ medical devices development.
5. Fluent in English with strong cross-cultural communication skills.
6. The conditions of employment may be appropriately relaxed for those who are particularly outstanding.
臨床監查員 若干人
崗位職責
1. 負責臨床試驗的具體實施和監查工作，確保項目按照國家GCP要求、試驗方案和中心標準操作程序進行，做好全過程的質量控制；
2. 負責整理和完善所有試驗文檔與資料，試驗用藥物和物品的正確保管、發放和使用；
3. 檢查并報告試驗進度和質量、病例報告表填寫、不良事件等各方面情況，對試驗研究過程中的不良事件和嚴重不良事件進行跟蹤，保障受試者權益和中心利益；
4. 定期歸納并提交監查報告，填寫相關報告及試驗記錄，確保數據真實準確、完整無誤；
5. 協調各研究中心、數據管理人員之間的溝通，培養并保持良好的關系；
6. 完成上級交辦的其它工作。
任職要求
1. 教育背景：藥學或醫學相關專業本科及以上學歷；
2. 工作經驗：至少1年CRO行業或藥企CRA工作經驗；
3. 專業技能：熟悉藥品注冊管理辦法、藥品臨床試驗及GCP等相關法規；
4. 語言能力：良好的英文讀寫能力；
5. 其他條件：有良好的人際關系和良好的溝通及語言表達能力。
Clinical Research Associate
Multiple positions available
Location: The Greater Bay Area International Clinical Trials Centre, Shenzhen, PRC
Job Description:
We are hiring detail-oriented Clinical Research Associates (CRA) to monitor and ensure the proper conduct of clinical trials.
This role will ensure compliance with GCP guidelines, manage trial documentation, and oversee the safety and efficacy of trial procedures.
Key Responsibilities:
1. Monitor clinical trials to ensure they are conducted in compliance with GCP guidelines, trial protocols, and SOPs.
2. Manage trial documents, including the distribution and storage of investigational drugs and trial supplies.
3. Track and report trial progress, adverse events, and ensure proper case report form completion.
4. Coordinate communication between research centers and data management personnel.
5. Submit detailed monitoring reports and maintain accurate trial records.
Requirements:
1. Education: Bachelor’s degree or above in Pharmacy, Medicine or related fields.
2. Experience: Minimum of 1 year of experience as a CRA within a CRO or pharmaceutical company.
3. Skills: In-depth knowledge of GCP guidelines and clinical trial regulations.
4. Language: Good in English Writing and Speaking.
5. Other: Good at maintain relationship and communication skills.
數據技術部
Data Technology Department
數據技術部總監 1人
崗位職責
1. 負責部門組建及團隊的規劃與建設，并組織開展業務工作；
2. 負責中心網站、信息化辦公系統、醫研企協作平臺、臨床試驗數據管理平臺的建設與維護，確保臨床研究數據庫安全；
3. 監督和管理臨床研究項目數據管理的相關活動，并對數據質量負責；
4. 負責團隊內的人員管理管理工作，對下級進行培養和考核；
5. 完成領導交辦的其他工作。
任職要求
1. 專業經驗：10年或以上相關工作經歷，有制藥企業或CRO公司團隊管理經驗者優先。
2. 教育背景：統計、信息/計算機等相關專業，碩士或以上學歷。
3. 政策法規：熟悉國內國際藥械監管的法律法規，及臨床試驗流程，熟悉臨床試驗數據管理相關國際標準；
4. 語言能力：具備在英語環境下勝任崗位職責的能力；
5. 特別優秀者，可適當放寬任職條件。
Director of Data Technology
1 position available
Location: The Greater Bay Area International Clinical Trials Centre, Shenzhen, PRC
Job Description:
We are hiring a Director of Data Technology to lead the development and management of the center’s data platforms, including clinical trial data management and IT infrastructure.
This role will ensure the security and quality of clinical research data and lead a team in maintaining cutting-edge data management practices.
Key Responsibilities:
1. Develop and maintain the center's website, information technology systems, and clinical trial data management platform.
2. Supervise data management activities for clinical research projects and ensure data quality.
3. Lead and manage the data technology team to meet international standards.
4. Ensure the security and proper handling of clinical trial databases.
Requirements:
1. 10+ years of experience in data management, preferably in pharmaceutical or CRO companies.
2. Strong team leadership and project management skills.
3. Master’s degree in Statistics, Information Technology, Computer Science or related fields.
4. Familiar with international standards for clinical trial data management.
5. Fluent in English with strong communication skills.
6. The conditions of employment may be appropriately relaxed for those who are particularly outstanding.
數據工程師 若干人
崗位職責
1. 負責中心數據管理系統的日常維護和優化，確保數據的準確性和安全性。
2. 參與數據采集、處理和分析流程的設計和實施，提高數據處理效率。
3. 與項目團隊協作，為臨床研究提供數據技術支持，確保數據的合規性和一致性。
4. 監控數據管理系統的性能，及時發現并解決技術問題。
5. 參與制定和更新數據管理的標準操作流程 (SOPs)，協助進行數據管理系統的升級和新技術的集成。
6. 為內部員工提供數據管理相關的培訓和技術支持。
任職要求
1. 教育背景：計算機科學、信息技術或相關領域的本科及以上學歷；
2. 工作經驗：至少2年的信息技術或數據技術工作經驗；
3. 專業技能：熟悉數據庫管理，了解臨床研究數據管理的法規和指南；
4. 其他條件：具備良好的分析問題和解決問題的能力，能夠獨立工作；優秀的溝通技巧，能夠與非技術人員有效溝通技術問題。
Data Engineer
Multiple positions available
Location: The Greater Bay Area International Clinical Trials Centre, Shenzhen, PRC
Job Description:
We are hiring skilled Data Engineers to maintain and optimize the center’s data management system.
This role will collaborate with project teams to provide data support for clinical research and ensure data accuracy and security.
Key Responsibilities:
1. Responsible for the daily maintenance and optimization of the Center’s data management system, ensuring data accuracy and security.
2. Participate in the design and implementation of data collection and management processes to improve data processing efficiency.
3. Collaborate with project teams to provide technical support for clinical research, ensuring data compliance and consistency.
4. Monitor the performance of the data management system, identifying and resolving technical issues promptly.
5. Assist in the development and updating of standard operating procedures (SOPs) for data management, and support system upgrades and the integration of new technologies.
6. Provide training and technical support on data management to internal staff.
Requirements:
1. Education: Bachelor’s degree or above in Computer Science, Information Technology or related fields.
2. Experience: Minimum of 2 years of experience in information technology or data management.
3. Skills: Familiarity with database management and knowledge of regulations and guidelines related to clinical research data management.
4. Other: Strong analytical and problem-solving skills, with the ability to work independently; excellent communication skills, able to explain technical issues to non-technical staff effectively.
政策法規辦公室
Regulatory Affairs Office
政策法規辦公室總監 1人
崗位職責
1. 緊密跟蹤國內外（中國、美國、歐洲等）藥事注冊相關法規和技術規范，及法規要求的最新動態；及時捕捉、解讀并反饋注冊相關政策的更新對于中心業務運營及戰略實施的影響，為中心決策提供建議，以確保中心的產品開發活動及相關研究的監管合規性；
2. 為其他部門提供注冊法規指導及支持，指導中心項目研發合規開展；
3. 建立和優化注冊法規事務相關內部規章制度和工作流程，在項目研發、申報、審批過程中，與內部各部門、外部檢測機構、臨床機構等各合作單位保持良好的溝通和管理工作，確保內外部各部門各單位的工作符合注冊相關監管法規的要求；
4. 建立與國內外監管和審評審批部門的良好關系，推動相關政策創新與落地；
5. 完成上級交辦的其它工作。
任職要求
1. 專業經驗：10年以上藥品注冊申報工作經歷，熟悉藥品研究開發全過程和藥品注冊相關法規，熟悉國際申報的流程與政策要求，有國際制藥公司注冊管理工作經驗優先；
2. 教育背景：臨床醫學、臨床藥學、藥事管理等相關專業碩士或以上學歷；
3. 語言能力：具備在英語環境下勝任崗位職責的能力；
4. 特別優秀者，可適當放寬任職條件。
Director of Regulatory Affairs
1 position available
Location: The Greater Bay Area International Clinical Trials Centre, Shenzhen, PRC
Job Description:
We are hiring a Director of Regulatory Affairs to oversee regulatory compliance for the center's drug development and registration processes.
This role will involve close tracking of international regulatory updates, providing guidance to internal teams, and maintaining relationships with domestic and international regulatory authorities.
Key Responsibilities:
1. Monitor and interpret regulatory
updates from
2. Provide regulatory guidance to other departments to ensure compliance in drug development and registration.
3. Establish and optimize internal regulatory processes and workflows.
4. Maintain strong relationships with domestic and international regulatory bodies to support policy innovation and approval processes.
Requirements:
1. 10+ years of experience in drug registration and regulatory affairs, with a deep understanding of drug development and international regulatory requirements.
2. Experience working in international pharmaceutical companies is preferred.
3. Master’s degree in Clinical Medicine, Pharmacy or related fields.
4. Fluent in English with the ability to perform regulatory duties in an English-speaking environment.
5. The conditions of employment may be appropriately relaxed for those who are particularly outstanding.
政策法規專員 若干人
崗位職責
1. 參與注冊項目的計劃、準備及執行，確保項目成功注冊；
2. 編制注冊申請資料并準備其他法規文件，確保經內部審閱和批準之后的資料及時遞交；
3. 維護注冊文件的存檔；
4. 關注法規的變化，確保所提交的資料是符合法規要求的并且適用于不斷變化的法規。
任職要求
1. 教育背景：藥學或醫學相關專業碩士及以上學歷；
2. 工作經驗：1-3年CRO或制藥公司工作經驗，第三方實驗機構或注冊工作經驗優先；
3. 專業技能：擅長文案工作，對相關注冊法規有一定的了解；
4. 語言能力：具有較好的中英文口語/書面溝通能力；
5.其他條件：熟練掌握計算機操作，熟練掌握Office辦公軟件。
Regulatory Affairs Specialist
Multiple positions available
Location: The Greater Bay Area International Clinical Trials Centre, Shenzhen, PRC
Job Description:
We are hiring meticulous Regulatory Affairs Specialists to manage regulatory submissions and ensure compliance with global regulations.
This job will assist in preparing and submitting regulatory documents and maintain up-to-date knowledge of regulatory changes.
Key Responsibilities:
1. Plan, prepare, and execute regulatory submissions for clinical trials and drug registrations.
2. Compile and submit regulatory documents, ensuring compliance with the latest requirements.
3. Archive and maintain regulatory documents and files.
4. Stay up-to-date with regulatory changes and ensure submission materials are compliant with evolving regulations.
Requirements:
1. Education: Master’s degree in Pharmacy, Medicine or related fields.
2. Experience: 1-3 years of experience in regulatory affairs, preferably within a CRO or pharmaceutical company.
3. Skills: Strong writing and document preparation skills; good understanding of regulatory guidelines.
4. Language: Fluent in both Chinese and English Speaking and Writing.
5. Other: Good at office suites.
臨床項目經理 2人
資格條件
1.在制藥企業或臨床CRO公司至少6年以上臨床運營、臨床監察或相關工作經驗，2年項目管理的工作經驗；
2.醫學或藥學相關專業本科以上學歷；
3. 熟悉GCP與臨床研究的分期與要求；
4.有領導團隊的能力與親和力，有部門管理的執行力，有跨部門協調與合作的能力。
5. 熟練使用計算機辦公軟件, 良好的英文讀寫能力。
崗位職責
1.負責單位各期臨床試驗的項目管理工作，對所負責的臨床研究項目進行全面的質量控制 和進度管理，確保所有試驗嚴格按照GCP、SOP、試驗方案和中國法律、法規進行；
2.根據合同約定及臨床試驗方案要求，制定項目管理計劃，確定臨床試驗的職責范圍、團隊成員、進度計劃、財務預算等內容，并在項目進行中不斷對項目管理計劃進行審核和 修改；
3.根據合同約定，定期匯報試驗進度，完成項目進展報告；
4.根據合同約定和項目計劃審核、批準項目組成員在實施項目過程中發生的實際工時和費 用，確保臨床試驗按照合同約定或與客戶商定的時限和預算內完成各項工作；
5.對所負責的臨床試驗項目，督導項目組成員按時完成臨床試驗的全面啟動、執行及結束工作；
6.在項目過程中識別、監測并及時應對各種風險，正確評估相應風險對項目的整體影響并采取合理的改進措施。負責臨床試驗項目文檔的完整性、準確性、及時性；
7.作為臨床試驗項目的主要聯絡人，代表公司及項目團隊同申辦方、主要研究者及分包商 保持及時有效的溝通，確保項目相關重要信息被準確完整的傳遞，培養并保持與中心及 客戶的良好關系；
8.及時處理項目中的應急突發事件，為項目組成員提供培訓；
9.及時與其他部門人員就所負責的研究項目進行溝通和協調，如商務發展、財務、行政、醫寫作、數據與統計質量保證人員等等。
10.協助商務部門尋求新項目合作及業務客戶拓展，提供臨床試驗相關信息，審核報價及相關合同文件，參加競標會；
11.根據合同約定及必要時對所負責的臨床試驗進行研究中心的協同訪視，并完成協同訪視報告；
12.支持并完成單位指派的其他臨床相關工作。
臨床注冊經理 1人
資格條件
1. 本科及以上學歷，有二類、三類產品國內、海外注冊5年以上經驗。
2. 專業背景：臨床醫學、藥學、生物醫學工程等；
3. 有過一些基礎的品質和體系經驗，有超過5年以上的國內、國際法規注冊經驗；
4. 熟悉并掌握海外醫療器械管理及注冊等相關法規及技術指導原則；
5. 熟悉注冊申報中的各個環節，具有良好的申報資料英文撰寫能力和對申報資料審核的能力；
6. 條理清晰、邏輯思維縝密、性格溫和，具有良好的溝通協調能力，團隊協作能力。
崗位職責
1. 按照新藥、器械注冊法規和申報要求，負責申報材料撰寫、申報、復核、修改等報批工作，及時跟進審批進度，做好溝通和協調；
2.負責產品GMP中試生產工藝的建立及優化，協助開展臨床試驗；
3.負責產品注冊過程中與內外有關部門協調和溝通，協助建立和維護相關的事務關系；
4.隨時跟進和更新最新的法規、產業政策和行業指導意見等，挖掘申報信息，整理反饋給部門負責人；
5.帶領團隊統籌產品海外市場準入工作（美國FDA、歐盟CE-MDR、東南亞等）的策劃、組織和實施，制定產品注冊策略，協同研發編制產品技術要求等相關檢測/注冊技術文件；
6.負責與海外監管部門對接，統籌處理各類事宜，積極完成相關監管任務；
7.負責跟蹤海外國家法規和標準變化趨勢；
8.負責單位內部法規意識的建立，并根據需要舉行法規知識培訓；
9.協助建立體系和相關審核認證工作，協助各部門處理法規問題。
3 JOB APPLICATION
如果您對以上發布的職位感興趣，請發送個人中文或英文簡歷(PDF)至recruitment@smart.org.cn, 郵件主題為“崗位名稱-姓名-專業-高校人才網” 【快捷投遞：點擊下方“立即投遞/投遞簡歷”，即刻進行職位報名】；或登陸https://smart.org.cn/recruit/administrative-support/index.html搜索崗位直接投遞。
If you’re interested in any role posted, please send your Chinese or English resume (PDF) to recruitment@smart.org.cn, with email subject template as “Job title - Name - Academic Specialty”. Or you can apply directly through https://smart.org.cn/recruit/administrative-support/index.html.
