Department 部门

Clinical Operations 临床运营部

Education 学历及专业要求

Pharmacy & Medical Related 药学，医学相关专业

Master 硕士研究生

Location 工作地点

Shanghai & Beijing 上海及北京

Number 人数

15

Responsibility主要职责

· Be responsible for the delivery of the studies at allocated sites and works in close collaboration with other CRAs and the local study team to ensure that quality commitments are achieved in a timely and efficient manner.

· Conduct site feasibility assessment.

· Contribute to the selection of potential investigators and leading investigator.

· Contribute to national Investigator meeting.

· Obtain and maintain essential documentation in compliance with international guidelines ICH-GCP, Company procedural documents and local regulations both in the office and at site.

· Actively participate in local Study Team meetings. Share information on patient recruitment and study site progress within local Study Team. Good knowledge in relevant Therapeutic area to train, support and advice Investigators and site staff in study related matters.

· Initiate monitor and close study sites in compliance with Company procedural Documents. Ensures compliance with protocols, regulatory requirements, and good clinical practices; writes follow-up visit reports.

· Drive performance at the sites.

· Update study related systems with data from sites per required timelines.

· Manage study supplies, drug supplies and drug accountability at study sites.

· Perform source data verification. Proactively identify study-related issues and escalates as appropriate.

· Complete monitoring visit reports within required timelines. Document the issues and follow up with sites until it is resolved.

· Ensure accurate and timely reporting of Serious Adverse Events.

· Work with data management to ensure quality of the study data. Ensure data query resolution.

· Prepare for activities associated with audit and regulatory inspection at responsible sites and/country in liaison with local study team lead and QA.

· Ensure compliance with company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).

· Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software

· Responsible for completeness and timeliness of the eTMF to maintain it “Inspection Ready”.

· Identify and report quality issues along with corrective and preventive actions to Local study leader/equivalent esp when its related to any data privacy, serious breaches and/impact to the reputation of company and safeguard patients’ rights and wellbeing.

Requirement任职要求

• Good medical knowledge and basic understanding of the drug development process.

• Fluent knowledge of spoken, read and written English.

· Team oriented and flexible. Ability to manage & prioritize multiple tasks with conflicting deadlinesAbility to work in an environment of remote collaborators

· Meticulous and detail-oriented

• Ability to travel nationally as required.

Department 部门

Clinical Operations 临床运营部

Education 学历及专业要求

Pharmacy & Medical Related 药学，医学相关专业

Bachelor and Above 本科及以上

Location 工作地点

Shanghai & Beijing 上海及北京

Responsibility主要职责

· Contribute to clinical study start-up, execution, close-out and reporting at country and/or site level.

· Assist local study team with preparation, handling, distribution, filing and archiving of clinical documentation and reports according to company policies and SOPs.

· Maintain Trial Master File (TMF) at country and/or site level per the scope of work. Assist with periodic review of study files for completeness. Preparation for relevant QC checks when applicable.

· Track site compliance and performance per study timelines via Clinical Systems (e.g. eTMF, CTMS, EDC, IRT system).

· Manage, coordinate, and track study materials, equipment and cost at country and/or site level. Track site budget related matters, including processing invoices, tracking payments, updating relevant trackers, coordinating the translation of required documents.

· Lead the practical arrangements and contribute to the preparation of internal and external meetings e.g. local study team meetings, monitor meetings, Investigator meetings. Liaise with internal and external participants and/or vendors at country and/or site level.

· Coordinate administrative tasks during the study process, audits and regulatory inspections, according to company policies and SOPs.

· Provide input into non-drug project work including training activities, meeting events and development of work instructions as needed.

· If needs arise, may support CRAs for on-site visits to assist with clinical monitoring duties upon completion of required trainings and with required approval. May perform assigned administrative tasks at study level.

· Ensure compliance with company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).

· Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software

· Identify and report quality issues along with corrective and preventive actions to Local study leader/equivalent esp when its related to any data privacy, serious breaches and/impact to the reputation of company and safeguard patients’ rights and wellbeing.

Requirement任职要求

· Level of education that supports Skills and Capabilities of the position and ensures successful conduct of accountabilities/responsibilities and appropriate interactions with internal/external customers

· Ability to develop advanced computer skills to increase efficiency in day-to-day tasks

· Good verbal and written communication and presentation skills

· work accurately, being proactive, independent and working in a team

· Ability to prioritise and manage multiple tasks with conflicting deadlines

· Good interpersonal skills and ability to work in a team environment

· Willingness to travel both domestically and internationally

· Proactively identify risks and possible solutions

· Ability to prepare presentation materials

· Demonstrate professionalism and mutual respect

· Willingness and ability to train others on study administration procedures

· Display excellent organization and time management skills,

· Computer proficiency

· Good knowledge of spoken and written English

Department 部门

Clinical Operations 临床运营部

Education 学历及专业要求

Pharmacy & Medical Related 药学，医学相关专业

Master 硕士研究生

Location 工作地点

Shanghai上海

Number 人数

2

Responsibility主要职责

· Be responsible to execute activities in Study set up, including but not limited to

· Review the key study documents, e.g. study protocol, Rave build specification, Edit check specification, Data Management plan, etc.

· Perform the User Acceptance Testing (UAT)

· Work with LDM in the process of Manual data review specification and External Data Transfer specification, etc.

· Be responsible to perform the data validation activities throughout the study life cycle, including but not limited to

· Query management

· Manual data review

· SAE reconciliation

· External data reconciliation

· Master the data management filing requirement and be responsible to upload the DM documents into eTMF system on timely manner with good quality.

· Support LDM on the activities to

· Collaborate with CRA to analyse the data issue trend at site and then support on the systematic data issue solution.

· Coordinate the medical data review process and manage the stakeholders of medical data review.

· Proactively identify the risk of data validation and work out the mitigation plan.

· Provide the study DM status report in the appropriate approach.

· Gain the knowledge of Dizal Clinical Data Standards and work on the relevant activities as necessary.

· Proactively identify the process gap and contribute on the process streamline task.

· Be capable to work on the activity which is authorized by LDM and proactively identify the risk of the delegation and provide the proposal as necessary.

Requirement任职要求

· Fluent English skill

· Proactive communication with others

· Can do attitude

· Open mind to learn new things

Department 部门

Clinical Development 临床开发部

Education 学历及专业要求

Medical Related 临床医学专业

Ph.D Degree 医学博士

Location 工作地点

Shanghai上海

Responsibility主要职责

· Work closely with physician for clinical development plan (including protocols) for Dizal projects

· Support physician to conduct successful clinical studies with all in-scope integrity (i.e., providing medical monitoring)

· Provide science review and analysis to support physician shaping clinical study design and product strategy

· Co-owners of clinical study delivery

· Work closely with physician for development documents (CIB, protocol and CSR, etc.)

· Work closely with physician to analyse and interpret clinical study results in partnership with other development functions

· Work closely with physician to form and run advisory board meeting; Be responsible for interacting and communicating with KOLs for development strategy and protocol design

· Support regulatory filing and registration

· Provide consultation to clinical operation colleagues on protocol design questions and answer protocol related questions from site investigators

Requirement任职要求

· General disease Knowledge

· General compound knowledge

· General Regulatory knowledge

· Investigator & site knowledge

· Medical monitoring

· Safety monitoring and evaluation of signals

· CSP/CSR content & data analysis

· Presentation & communication skill

· Clinical trial landscape and competitive intelligences

Department 部门

Clinical Development 临床开发部

Education 学历及专业要求

Clinical Pharmacology, Medical Related 临床药理及医学相关专业

Ph.D 博士研究生

Location 工作地点

Shanghai上海

Number 人数

2

Responsibility主要职责

· Execute scientifically robust and efficient clinical pharmacology strategies for NME and/or development candidates, working together with senior members.

· Contribute to overall compound development via application of quantitative methods to integrate knowledge of PK, PD, patient characteristics, disease states, and drug-drug interactions to optimize dose selection, dosage regimens and study designs throughout drug development.

· Provide the clinical pharmacokinetics and pharmacodynamics expertise and support required for Investigator Brochures, Clinical Trials Applications, Marketing Applications, regulatory meetings, and responses to regulatory questions.

· Work effectively in matrix environment, managing ClinPharm deliverables in accordance with timelines and overall project goals.

Requirement任职要求

· Willingness to Acknowledge Areas for Growth: Understands need for growth and is receptive to constructive feedback.

· Detail-Oriented: Follows precise procedures and demonstrates thoroughness in performing job tasks and assignments.

· Communication Skills: The ability to convey both written and verbal information effectively and efficiently.

· Fluent in spoken English and good in written

Department 部门

Clinical Development 临床开发部

Education 学历及专业要求

Mathematics, Statistics Epidemiology 数学，统计相关专业

Ph.D 博士研究生

Location 工作地点

Beijing 北京

Number 人数

1

Responsibility主要职责

· Provides statistical expertise to support the study design, implement and interpretation of

· study result, regulatory submissions, publication and commercialization with supervisor

· Assists analysing internal and external information to inform design decisions and the

· development of decision criteria

· Identifies opportunities to improve the methodology and provide practical solutions for

· problems

· Identifies and applies statistical methodology to improve the process and delivery activities

· Contributes to the development of best practice to improve quality, efficiency and

· effectiveness

Requirement任职要求

· Excellent working knowledge of SAS software

· Good Communication skills

· Collaboration required

· Ability to apply statistical expertise to problems, problem solving and quality focus.

· Excellent interpersonal skills with high level of proficiency in English

Department 部门

Chemistry, Manufactory and Control 化学，生产与质量控制部

Education 学历及专业要求

Analytical Chemistry 分析化学相关专业

Bachelor and Above 本科及以上

Location 工作地点

Wuxi 江苏无锡

Number 人数

2

Responsibility主要职责

• Act as an analytical project representative in a CMC product development team.

• Plan all analytical activities and perform phase appropriate method development/validation/transfer and testing for raw materials, API, in-process, and finished products.

• Manage analytical activities in CRO and CDMO

• Lead GMP method transfer activities between AR&D and QC.

• Draft and revise Standard Operating Procedures.

• Perform analytical investigations of deviations and OOS related to GMP manufacturing and QC testing.

• Contribute to the authorship and organization of documents that support submissions to Health Authorities.

• Design and Manage GMP stability studies to support clinical studies.

Requirement任职要求

• BS, MS, or PhD in analytical chemistry or related discipline and 0-10 years of experience in analytical development or quality control

• Experience working with or familiarity with GMP CROs and CDMOs.

• Understanding of GMP principles

• Prior experience with several of the following techniques: HPLC, LC-MS, GC, GC-MS, TGA, KF, DSC, and XRPD.

• Intermediate statistical knowledge for analytical data analysis

• Excellent communication skills with the proven ability to build open and collaborative relationships and work effectively as a member of a multidisciplinary team

• Is willing to work in Shanghai before 2022 but in Wuxi, Jiangsu beyond 2022

Department 部门

Quality Assurance 质量保证部

Education 学历及专业要求

Chemistry, Pharmacy 化学,药学相关专业

Master 硕士研究生

Location 工作地点

Shanghai 上海

Number 人数

1

Responsibility主要职责

· Work to support the creation and revision of procedures in support of process improvements to Dizal’s Quality System.

· Responsible for document management activities, including but not limited to document lifecycle management and archives management.

· Responsible for training activities, including but not limited to maintain training matrix, coordinate to complete training task, maintain training material and training record, track and analyze training implementation

· Support change control and supplier quality management work.

· Coordination with all functions regarding compliance and quality issues

· Participate in the establishing and maintaining of the quality system & compliance program to ensure regulatory compliance.

Requirement任职要求

• Minimal Bachelor’s degree in relevant Pharmaceutical, Chemistry or Biology preferred.

• Good written and oral English

• Good Communication skills

Department 部门

Manufactory 生产基地

Education 学历及专业要求

Pharmacy, Mechatronic药学、机械等相关专业

Bachelor 本科

Location 工作地点

Wuxi 江苏无锡

Number 人数

3

Responsibility主要职责

· 参与新厂房的建设，如文件准备、现场监工等；

· 参与新设备确认，特别是PQ；

· 协助技术工程师，将产品转移至临床或商业生产；

· 协助所有PPQ相关活动、RA、协议、培训、执行、报告；

· 协助技术工程师进行清洁验证的相关工作；

· 参与解决生产过程中的工艺问题；

· 确保满足所有适用的安全、健康和环境要求，以符合集团公司政策和当地法律要求。

· Participate in the construction of new plant, such as document preparation, on-site supervision, etc.

· Participate in the new equipment qualification, especially for the PQ.

· Assisting the Technical Engineer to transfer the product to clinical or commercial production.

· Participate in all PPQ related activities, RA, protocol, training, execution, report.

· Assisting the Technical Engineer to prepare the RA and protocol for cleaning validation.

· Participate in solving the process issue during the production.

· Ensure that all applicable Safety, Health & Environment requirements are fulfilled to comply with corporate group policy and local legal requirements.

Requirement任职要求

• 药学、机械类大学本科及以上学历；

• 英语四级及以上；

• 具有良好的沟通和写作能力；

• 具有较强的工作责任心和执行力。

• Bachelor degree or above in pharmacy and machinery。

• CET-4 or above。

• Good communication and writing skills。

• Strong sense of responsibility and execution。

Department 部门

Board Office 董事会办公室

Education 学历及专业要求

Legal 法学专业

Bachelor 本科

Location 工作地点

Shanghai 上海

Number 人数

2

Responsibility主要职责

· 根据法律、法规、监管要求等信息披露相关规定，及时、准确编制报送信息披露文件。

· 负责信息披露的协调工作，协调公司各部门之间、投资者、中介机构协作与关系。

· 起草、整理给监管部门报送的相关文件，完成监管部门要求的各项调查。

· 组织筹备公司三会召开，包括年度股东大会、临时股东大会、董事会会议及其专门委员会会议、监事会会议，准备会议材料。

· 做好证券监管政策法规的梳理、整理、传达工作。

· 协助组织业绩说明会、投资者及券商调研等工作。

· 跟踪公司舆情工作。

Requirement任职要求

• 本科及以上学历，法律英语、法学（英语）专业、法律语言学、法律翻译等相关专业；

• 具有较强的中英文写作能力、良好的沟通协调能力；

• 有投行、律所资本市场部、公司证券部实习经历者优先；

• 学习能力和抗压能力强，具有良好的职业操守和团队合作精神。

Department 部门

Board Office 董事会办公室

Education 学历及专业要求

Journalism & Communication新闻传播相关专业

Bachelor本科

Location 工作地点

Shanghai 上海

Number 人数

1

Responsibility主要职责

· 建立并维护与法批媒体、财经媒体的合作关系，处理与媒体记者的接洽，执行安排公司董事、高级管理人员和其他重要人员的采访报道。

· 协助制定媒体关系管理策略和舆情监测引导策略，重大敏感信息收集与分析、危机公关实施媒体监控，在重大事项发生后配合公司相关部门提出并实施有效处理方案，积极维护公司的公共形象。

· 负责公司宣传，包括宣传品（画册/PPT/宣传片/展厅/展板），网站、企业微信内容输出及平台运营，新闻发布会，推介宣传活动，企业社会责任等。

Requirement任职要求

• 新闻传播学等相关专业；

• 具有较强的中英文编辑、出色的沟通协调能力；

• 有财经媒体、行业媒体等工作和实习经历者优先；

• 学习能力和抗压能力强，具有良好的职业操守和团队合作精神。

Department 部门

Finance 财务部

Education 学历及专业要求

Finance 财务相关专业

Bachelor 本科

Location 工作地点

Shanghai 上海

Responsibility主要职责

· RMB and foreign currency payment arrangement and process and be the main contact with banks.

· Bank journal posting in time.

· Monthly bank account balance reconciliation.

· Cash management.

· Prepare Cash Flow budget and Cash Flow report.

· Voucher scan, collation, and filing.

· Other ad hoc projects and tasks as assigned.

Requirement任职要求

· Solid basic accounting knowledge. Accounting related certificate is a plus.

· Good communication skills, initiative and sense of responsibilities, ability to work under pressure.

• Be good at Microsoft software, especially excel.

• Good English in both oral and written.

Department 部门

Operation公司运营部

Education 学历及专业要求

Legal, Management and English法律，管理，英语等相关专业

Bachelor 本科

Location 工作地点

Shanghai 上海

Responsibility主要职责

· Work as office consumable source centre to provide daily office consumable align with business needs, including inventory management, cost control and office consumable optimization.

· Take responsibility of front desk role to host all level company visitors by needs, including coordinate the entry permission and registration, support meeting/building tour and etc. Work as communication front door to handle calls and transformation to internal staff to ensure the message delivery smoothly and information safety.

· Support company level activities planning, organizing and implementation.

· Be responsible for payment process of operation department in timely and compliance manner to ensure the daily operation continuity.

· Support office decoration timely by needs to reflect company culture.

· Mare sure conference room supplier sufficient to meet the meeting needs.

· Ensure reception area is tidy and presentable, with all necessary stationery and material

· Maintain office security by following safety procedures and controlling access via the reception desk

· Perform other clerical receptionist duties such as filing, photocopying, transcribing and faxing

Requirement任职要求

· Quick learner with the ability to handle a variety of tasks;

· Excellent command of both written and spoken English;

· Independent, creative and with a strong sense of responsibility;

· Accountable, open minded and sense of innovation;

· Able to work in the pressure and result-driven;

Department 部门

Operation公司运营部

Education 学历及专业要求

Legal, Management and English法律，管理，英语等相关专业

Bachelor 本科

Location 工作地点

Shanghai 上海

Responsibility主要职责

· Support the staffing activities and projects, including but not limit to announcements, on-board, exit, contract renew, probation, promotion, internal transfer and etc;

· Conduct recruitment and selection activities including but not limited to advertising, interviewing, testing, and selecting candidates, checking references and offering, etc;

· Develop creative recruitment channels to ensure the efficiency of resource need, and select appropriate recruitment channel according to different levels vacancy in order to attract talent and save recruitment cost;

· Provide recruiting analysis report to let management team well know the status of recruitment progress, and rational proposal prospectively if required.

· Plan, monitor and manage all new employees’ new hire orientation and probation evaluation under related HR policies and procedures;

· Support on HR policies regular review and refresh.

· P-file management: manage all p-files, ensure all p-files updated in time;

· Performs other duties or projects as assigned;

Requirement任职要求

· Quick learner with the ability to handle a variety of tasks;

· Excellent command of both written and spoken English;

· Independent, creative and with a strong sense of responsibility;

· Accountable, open minded and sense of innovation;

· Able to work in the pressure and result-driven;

Department 部门

Operation公司运营部

Education 学历及专业要求

Computational Science 计算机相关专业

Bachelor 本科

Location 工作地点

Shanghai 上海

Responsibility主要职责

· Provide IT software and hardware support for drug development, production and commercialization

· Develop Ad-hoc R&D support tools based on Java, VBA, Python, Shell.

· Establish data analysis method and database platform based on AI and Cloud technology

· Work as business partner to participate in the implementation of IT digital systems

· Participate in IT documents development and update.

· Maintenance and support the existing information system.

Requirement任职要求

• Bachelor’s degree or above in computer science, electronic information, bioinformatics and other related majors

• Have an in-depth understanding of computer hardware and network knowledge, owning Linux experience is plus.

• Master at least one of Java, Python, C#, JavaScript languages, etc.

• Enthusiastic, good communication and coordination, willing to do supportive works.

• English CET-6, with certain oral and written skills.