1.Collect, analyze, and organize medical information related to clinical projects.
2.Draft clinical trial protocols and supporting documents, including investigator manuals, summary reports, and study application materials, and responsible for updating the research plan and related documentation.
3.Coordinate with data management and statistical units, responsible for approving data management and statistical documents and reports, such as DMP, DVP, DMR, SAP, and SAR, and design the (e)CRF.
4.Responsible for medical coding review and medical review work.
5.Responsible for the medical evaluation and quality review of company clinical study AE/SAE and report according to national laws and regulations requirements.
6.Support project managers in handling medical issues during clinical trials.
7.Collaborate with the project operations team to ensure the progress of clinical research.
8.Responsible for registering clinical trials on relevant websites in China and abroad and writing and publishing articles in relevant professional journals.
9.Establish a good relationship with clinical experts and investigators.

1.Master degree or above in clinical medicine, preventive medicine, or related fields.
2.At least 3 years of relevant work experience, preferably with clinical oncology treatment experience, fresh graduates are also welcome.
3.Familiar with relevant regulations and technical guidance principles such as ICH-GCP and Chinese GCP.
4.Good English and medical information search skills, as well as a good command of English reading and medical writing abilities.
5.Good analytical and judgment skills.
6.Meticulous and responsible, and be able to adapt to fast-paced and work under pressure.

1.Responsible for the management of individual case safety reports, ensuring that all processes and operations strictly comply with the company’s SOPs, ICH guidelines, and drug safety regulations of NMPA, EMA and FDA.
2.Responsible for or participate in the management of drug safety signals and risks, and for or participate in the writing of drug safety documents.
3.Responsible for or participate in the construction and maintenance of drug safety systems, establish and maintain company SOPs, WI and other documents, and improve and optimize drug safety workflow.
4.Responsible for the collection, processing, evaluation, reporting, and filing of individual case safety reports.
5.Responsible for or participate in the writing of drug safety documents, including but not limited to: RCP, RMP, DSUR, PSUR, study protocols, investigator brochures, annual reports, etc.
6.Responsible for or participate in the management of drug safety signals and risks.
7.Maintain good communication with relevant personnel of outsourcing companies, and do relevant management work to ensure timely and accurate completion of drug safety outsourcing work, and conduct quality control of outsourcing work.
8.Responsible for other drug safety work assigned by superiors.

1.Bachelor degree or above, preferably in medicine, clinical medicine or related fields;
2.Bachelor degree or above, with at least 6 years of working experience in drug safety surveillance or related pharmaceutical fields;
3.Proficient in using Office software: Word/Excel/PPT;
4.Proficient in reading English materials, fluent in English, and able to write reports in English;
5.Responsible, analytical and problem-solving skills, communication skills, and team collaboration skills.

1.Prepare the various work requirements for clinical trials in accordance with ICH-GCP and SOPs, and complete the required reports in a timely manner.
2.Independently complete the selection and qualification evaluation of the research center and investigators.
3.Independently and correctly assist the investigator in submitting applications to the management authority and ethics committee based on the core documents developed by the project team.
4.Negotiate, execute and track payment and voucher returns with the research center and investigators for clinical trial protocols based on project team agreements.
5.Conduct effective start-up and monitoring of research centers to ensure that investigators comply with the protocol, laws and regulations, and GCP, and complete monitoring reports and investigator follow-up letters in a timely manner.
6.Verify original documents, including informed consent forms, check the correct handover, dispensing, use and recovery of the trial drug, and fully report serious adverse events within the time limit.
7.Manage the clinical trial-related documents and complete data cleaning in a timely manner.
8.Participate in and organize important meetings for clinical trials, including protocol discussion meetings and investigator meetings.
9.Assist the supervisor in completing some project management work for clinical trials.

1.Bachelor degree or above in clinical medicine, pharmacy or related field;
2.At least 2 years of experience in clinical trial monitoring, experience in oncology clinical monitoring is preferred;
3.Familiar with ICH-GCP and Chinese GCP regulations;
4.Good communication and time management;
5.Outgoing, sincere, conscientious, and responsible;
6.Able to adapt to frequent business trips and a fast-paced, high-intensity work environment.

1.Collect, analyze, and organize medical information related to clinical projects.
2.Draft clinical trial protocols and supporting documents, investigator manuals, summary reports, and research proposal materials, and manage updates to research protocols and related materials.
3.Liaise with data management and statistical units, responsible for approving data management and statistical-related documents and reports (such as DMP, DVP, DMR, SAP, SAR, etc.), and design (e)CRFs.
4.Responsible for medical coding and medical review.
5.Responsible for medical assessment and quality review of company clinical study AE/SAEs, and report and handle according to national laws and regulations.
6.Support project managers in dealing with medical issues related to clinical trials.
7.Collaborate with the project operations team to ensure the progress of clinical research.
8.Responsible for the registration of clinical trials on relevant domestic and international websites and writing and publishing articles in relevant professional journals.
9.Establish good relationships with clinical experts and investigators.

1.Master’s degree or above in clinical medicine, preventive medicine or related fields;
2.At least 3 years of relevant work experience; experience in clinical oncology treatment is preferred;
3.Familiar with relevant regulations and technical guidance principles such as ICH-GCP and China GCP;
4.Good ability in English and medical information retrieval, as well as good English reading and medical writing skills;
5.Good analytical and judgment skills;
6.Meticulous and responsible, and be able to adapt to fast-paced and work under pressure.

1.According to the company’s strategy, assist in project evaluation, conduct professional evaluations of the company’s strategic potential license-in projects, and coordinate with medical and R&D to give, analyze, and summarize professional opinions.

2.Follow up and collect cutting-edge information and cooperation opportunities in the pharmaceutical industry on time, carry out research on opportunities related to the company’s R&D direction, and provide direction for setting new programs

3.Coordinate with the relevant departments to conduct due diligence on the early development investment, production supply, market operation, and income of the partner’s products, and draft the report for the management to evaluate the risk and return.

4.Investigate the target company’s products and analysis of development costs, and operating costs, look up relevant information and literature, complete the establishment of product input income and valuation models, and evaluate the company and products

5.Project establishment research: analyze the feasibility of the target products from multiple dimensions such as market size, epidemiology, diagnosis, guidelines, treatment status, patents, domestic application competition, sales forecast, etc., and write project research reports

6.Carry out follow-up research and analysis of industry policies, innovation and development trends, and cutting-edge scientific trends in the pharmaceutical industry, provide a basis for the company’s R&D strategic decision-making, assist in making company decisions, and formulate regular reviews of R&D strategies

7.Other tasks delivered by the leader

1.Master’s degree or above in biology, pharmacology, medicinal chemistry, translational medicine, clinical medicine, and other related majors, more than three years of relevant drug project work experience in medium and large pharmaceutical enterprises, with multi-module experience in drug R&D, research and project development, investment project evaluation, market research, and promotion is preferred

2.Have proficient market analysis ability, skilled in querying drug R&D databases, such as Cortellis, Globaldata, IMS, and other databases or information resources, familiar with market research, various aspects of drug R&D registration and approval, and can analyze drug patents, laws, and regulations

3.Have strict scientific thinking and scientific insight, logical thinking, and can think independently to carry out project research

4.Fluent and proficient in English; proficient in reviewing and translating professional foreign language literature

5.Strong sense of responsibility and execution, good cross-departmental communication skills and teamwork spirit.

1.Requirements: pharmacy, biology, chemistry, and other related majors. Ph.D., PharmD, and MBA are preferred.

2.Experience:

a) 8+ years of experience in pharmaceutical, formulation, and new product development, multinational company experience.

b) Successfully led the screening and development of new products.

c) In-depth knowledge of Chinese new drug development pathways, processes, and related regulations.

d) Familiar with various dosage forms and their rational application in clinical settings, and a good understanding of the development direction of formulation technology.

e) Successfully led co-development and manufacturing projects.

f) Experience in leading or participating in the commercialization collaborations of new products is preferred.

g) Experience in formulation product manufacturing, pharmacovigilance, and clinical experience is preferred.

1.Conduct research and development work for biology projects according to the project plan, design and establish biochemical and cell testing platform as well as in vivo activity evaluation platform to ensure the evaluation of compound activity in vitro and in vivo.
a) responsible for developing enzyme activity detection methods and drug screening work;
b) responsible for constructing cell lines and developing experimental detection methods related to cells and drug screening work;
c) familiar with, understand and participate in various enzyme kinetics, affinity experiments, covering TR-FRET, Alpha and other mainstream drug screening technologies, as well as some conventional cell experiments, such as ELISA, Western Blot, qPCR, flow cytometry, etc.;
d) participate in the establishment of PDx, CDx animal models, etc.
2.Actively participate in feasibility assessment and compound mechanism research of early-stage biological discovery projects.
3.Participate in part of the research on the transformation of clinical candidate compounds in translational medicine.
4.Record experimental results in a timely, accurate, complete, and scientific manner, analyze data, solve problems, and summarize experimental reports.
5.Search literature, track and develop new methods and technologies.
6.Communicate with CRO in a timely manner and provide assistance and guidance for problems that arise in the project.
7.Complete other laboratory rotation and instrument consumable management tasks assigned by the company.

1.Bachelor degree or above in immunology, cell and molecular biology, biochemistry, biology, pharmacy, or bioengineering, overseas Ph.D. is preferred;
2.1-3 years of work experience in a pharmaceutical R&D company preferred;
3.Proficient in using common instruments and software in biochemical and biological laboratories; proficient in various biochemical, cellular, and animal experiments;
4.Good English reading and writing ability, able to proficiently search and read foreign literature;
5.Strong innovation, initiative, and independent working ability; adept at analyzing, summarizing, and synthesizing internal experimental data and external literature to propose feasible strategies;
6.Good execution ability and team collaboration spirit.
7.Good work initiative, strong sense of responsibility, and good communication and coordination skills.

1.Weigh samples using analytical balance and keep records of all measurements. Report deviation immediately.
2.Maintain daily operation and documentation of the formulation laboratory environment.
3.Record, organize, and analyze data. Provide regular updates on research progress.
4.Complete any additional tasks assigned by superiors.

Basic knowledge in pharmaceutical formulation or chemistry-related field.

1.Search for literature independently and establish experimental methods;
2.Responsible for various aspects of biological experiments, such as cell culture, transfection, and characterization, and assist in completing research projects with challenegs;
3.Pay attention to details when executing laboratory tasks and solve some problems that arise during the experiment;
4.Clearly and completely record experimental data, submit experimental plans and reports on time, analyze experimental data, and ensure the smooth completion of the project.

1.Master degree in a field related to molecular biology and cell biology with 0-2 years of work experience. Strong experimental skills;
2.Proficient in cell culture and the construction of stable cell lines;
3.Experience in drug screening with cell-based assays preferred;
4.Good English reading and writing skills, proficient in reading literature;
5.Proactive, responsible, and good communication and coordination skills.

1.Independently search and analyze literature and design preliminary synthetic routes for compounds based on the literature.
2.Proficiently perform chemical reactions, comprehensively analyze the results, and assist in completing research projects with challenges.
3.Solve problems that come across during experiments.
4.Clearly and completely record experimental data and write experimental reports.

1.Master degree with at least 2 years of relevant work experience in the field of oncology; or Bachelor degree with at least 4 years of relevant work experience in the field of oncology with a major in organic chemistry or medicinal chemistry or related field. Experience in new drug development is preferred.
2.Proficient in relevant professional knowledge and experimental skills, able to provide scientific suggestions for the project;
3.Good English reading and writing skills, proficient in searching for literature;
4.Proactive, responsible, and good at communication and coordination.

1.Independently conduct literature research and establish experimental methods;
2.Responsible for various aspects of biological experiments, including cell culture, cell transfection, and characterization, and assist in completing research projects with challenegs;
3.Pay attention to details in the execution of laboratory tasks and solve problems come across during the experiment;
4.Complete experimental records clearly and comprehensively, submit experimental plans and reports on time, analyze experimental data to ensure the completion of projects.

1.Master degree in a relevant field such as molecular biology and cell biology, with strong hands-on laboratory skills;
2.Familiar with cell culture and related experiments for stable cell line construction;
3.Previous experience in drug screening using in vitro cell-based assays is preferred;
4.Proficient in reading and understanding English literature;
5.Possess a proactive work attitude, strong sense of responsibility, and good communication and coordination skills.

1.Follow relevant rules and regulations, as well as SOPs, to perform pre-treatment of biological samples.
2.Develop and validate LC-MS/MS experimental methods for bioanalysis and analyze various biological samples, including but not limited to tissue homogenates, serum, and urine.
3.Communicate project progress and resolve technical issues during experiments with the project leader in a timely manner.
4.Write and review bioanalytical data and research reports, including method development, validation, and sample analysis reports.
5.Record original experimental data in time, ensure the accuracy, clarity, and integrity of experimental records, and organize, review, and archive experimental data.
6.Perform daily operation and maintenance of basic analytical instruments and equipment.
7.Assist in training new employees.
8.Perform other tasks assigned by the supervisor.

1.Master degree in pharmacy, chemistry, biology, or related field.
2.Previous experience with GMP and GLP, with experience in biological sample analysis preferred.
3.Able to proficiently search and read literature, with the ability to summarize information and problem-solving skills.
4.Proactive, responsible, detail-oriented, with strong teamwork and communication skills.

1.Follow relevant regulations, laws, and SOPs to perform pre-processing of biological samples.
2.Use LC-MS/MS to analyze various types of biological samples including but not limited to tissue homogenates,serum,and urine.
3.Write and review biological analysis data and research reports, including method development, validation, and sample analysis reports.
4.Record original experimental data in a timely manner, ensuring the accuracy, clarity, and integrity of experimental data, and organize, review, and archive experimental data.
5.Perform basic daily operations and maintenance of analytical instruments and equipment.
6.Perform other tasks assigned by the supervisor.

1.Bachelor degree in Pharmacy, Chemistry or Biology, or a related field.
2.Experience with GMP and GLP, with a preference for experience in biological sample analysis.
3.Ability to proficiently review and read literature, with a certain ability to summarize information and problem-solving skills.
4.Proactive, responsible, careful, and detail-oriented, with excellent teamwork and communication skills.

1.Conduct experimental operations related to biological sample analysis in accordance with relevant regulations and the company’s standard operating procedures;
2.Assist project leaders in developing, validating, and analyzing clinical samples of chemical drugs and biological samples;
3.Assist project leaders in preparing and organizing project-related documents and experimental consumables/reagents;
4.Assist project leaders in the entire process from experimental design to implementation;
5.Assist project leaders in regulatory department and customer audits and respond appropriately to audit reports;
6.Train new employees in the group and establish the project team;
7.Propose improvement measures for work processes and management methods to senior management and assist in their implementation.

1.Biological or pharmaceutical related field, with 3-4 years of experience in GLP bioanalysis;
2.Familiar with the basic process of bioanalysis, and familiar with FDA, OECD, and NMPA regulations related to bioanalysis;
3.Familiar with biological sample preparation methods, excellent laboratory skills, and proficient in operating LC-MS/MS and corresponding software;
4.Ability to develop method and search for literature, and be able to develop and optimize bioanalytical methods under the guidance of the project leader;
5.Have relevant method validation and sample analysis experience, and be able to conduct method validation and bioanalytical sample analysis relatively independently under the guidance of the project leader;
6.Able to independently write method validation and sample analysis plans, methods, and reports;
7.Strong logical thinking and good English reading and writing abilities;
8.Good communication skills, strong sense of responsibility, and good team player.

1.Systematic training in biological sample preparation for analysis, including but not limited to tissue homogenization, serum, and urine;
2.Systematic training in LC-MS/MS quantitative analysis;
3.Systematic training in WatsonLIMS;
4.Systematic training in GLP;
5.Retention plan.

1.Bachelor or Master degree in pharmacy, chemistry, biology, analytical chemistry, or related fields;
2.Fresh grads or current students;
3.Proficient in reading and understanding literatures, with the ability to summarize information and problem-solving skills;
4.Proactive, strong sense of responsibility, meticulous, with good team collaboration and communication skills.

1.Responsible for developing, implementing, and continuously improving the quality management system for R&D;
2.Responsible for reviewing R&D instrument and equipment validation documents, Logbooks, and other related documentation;
3.Responsible for reviewing and managing R&D department’s original records, including conducting regular checks on the compliance, integrity, and authenticity of R&D experiment records, and preparing reports. Also responsible for conducting periodic checks on the timeliness, authenticity, and integrity of R&D responsible records;
4.Assisting the Manager in conducting various audits and official inspections of the R&D quality system;
5.Coordinate with company supervision and preparing on-site documentations.

1.Bachelor degree or above in chemistry or pharmaceutical related majors;
2.At least 1 year of relevant work experience, outstanding fresh graduates can also be considered;
3.CET-4 or above, proficient in using office software such as Word and Excel;
4.Strong sense of responsibility and ownership, ability to learn, and hard-working;
5.Good communication skills and a team player.