Clinical Trial Project Manager (PM) - Job details
1.Responsible for the quality monitoring and management of clinical research projects, responsible for the inspection of centers to ensure that the trial projects are in accordance with the trial plan, the company's SOP, GCP regulations;
2. Communicate with the sponsor, center screening, determine the main investigators and participants, complete project budget in time, submit to superiors for approval and promote implementation;
3. Develop the project schedule, assist CRA of each center to complete the schedule of each center, complete the full start, implementation and termination of the pilot project as planned,communicate and coordinate with other personnel related to the project;
4. Assist CRA of the project team to sort out, submit the ethical data of each research center, obtain the center's ethical approval;
5. Responsible for the budget and purchase of test materials, including the printing, distribution and transportation of case report forms, informed consent forms and other materials;
6. Review the clinical research contracts of each center and guide CRA to complete the negotiation and signing of research contracts with each center;
7. Conduct pre-launch training for project team members, promote the launch of each center as planned; review report of project team members, communicate with project members, perform quality control and progress reports;
8. Responsible for CRA training and management of clinical monitors of the project team member, assist CRA in formulating a monitoring plan,selectively conduct collaborative monitoring to ensure the progress and quality of the trial ；
9. Maintain a good cooperative relationship with researchers;
10. Other work assigned by superiors.
1. Bachelor degree or above in clinical medicine or pharmacy, 5 years of clinical trial work experience, 2 years of project management experience;
2. Work independently, team spirit, adapt to business trips;
3. written and oral expression skills, active communication, communicate with various types of clients/researchers, good relationships; sense of service and the potential to be customer-centric;
4. Team organization, project management skills, such as organizing project team meetings, respond to problems and come up with solutions;
5. Team training and public speaking skills;
6. Experience in phase I clinical trials is preferred.
Medical manager - Job details
1. Receive the clinical trial project, prepare the first draft of the clinical trial project medical plan;
2. Modify the medical plan based on the opinions of PI, the project inspection department, the statistics department;
3. Prepare the first draft of the project plan, researcher's manual, informed consent, research medical record, CRF, PPT;
4. Participate in the coordination meeting, present the PPT according to the plan and materials recognized by the medical director, listen to and record the expert opinions of the coordination meeting, modify the plan accordingly;
5. Adjust the plan according to the opinions of the ethics committee;
6. During the project test, answer technical questions raised by researchers and project manager;
7. Receive the first draft of the statistical report of the statistics department, write draft of the summary report, communicate with the statistics department and the project manager, make corresponding adjustments to the summary report.
1. 3 years of work experience, clinical work experience, major in medicine or clinical medicine;
2. Strong medical editing skills, proficient in medical professional literature retrieval, strong text organization and abstract ability;
3. Clinical knowledge, good logical thinking and analytical judgment.
Marketing Specialist - Job details
1、Develop new customers, recommend new drug projects promoted by the company, send project emails and faxes regularly according to customer needs, and complete personal annual and quarterly indicators；
2、Promote the project and maintain the relationship with the customer according to the customer's project situation；
3、Increase the number of customers who can negotiate specific projects or customers who can negotiate project prices and cooperation methods every month.；
4、Maintain good communication with customers, grasp customer needs in real time; provide customers with active, enthusiastic, thoughtful service；
5、Master the market data and other basic information of new drug projects；
6、Master the new drug development process and new drug regulations。
1、Professional background in pharmacy, bachelor degree or above；
2、Have marketing and management experience, have market development capabilities, more than 1-2 years of relevant work experience；
3、Familiar with drug development, registration, technology transfer and other related policies；
4、Strong sense of responsibility, good professional ethics and teamwork spirit。
Office Director - Job details
1. Management of the office.
2. Affairs management of the test center
3. Training and assessment, file management.
4.Revision, distribution of documents.
5. Customer visits management , Collection and registration of complaints and feedback, reception of outsiders
6. Organize equipment acceptance, maintenance, equipment file management
7. Purchase and acceptance of equipment, consumable materials in the testing center.
8. Customer entrustment and sample management.
9. Follow up inspection work
1. Bachelor degree or above, major in pharmacy, pharmaceutical analysis, medicinal chemistry;
2. Experience in management of the office
3. Experience in Analysis and CNAS is preferred
4. Good communication skills, problem-solving ability
Inspector - Job details
1. Apply ICP-MS/GC-MS/IC to research and detect impurities in materials and preparations;
2. Write experiment plan and report;
3. Lead the design, implementation, solve problems in the experiment process;
4. Participate in the training of the analysis and testing department;
5. Write test records, summarize and analyze test results.
1. Chemistry, pharmaceutical analysis majors, bachelor degree of 4 years work experience, master degree of 2 years work experience;
2. Familiar with use of ICP-MS instrument, detection, maintenance;
3. Able to design experimental plan;
4. Experience in packaging material compatibility research is preferred.
Formulation Process Director - Job details
1. Responsible for technical guidance and program control of the research and development of the process of the consistency evaluation center;
2. Responsible for technical guidance and problem solving for the amplification of the consistency evaluation center;
3. Responsible for the guidance, coordination and technical support of the consistency evaluation center technology transfer;
4. Coordinate the registration and application of preparations.
1. Pharmacy major, master's degree or above, 10 years work experience;
2. Experience in R&D and production of oral solid, injection preparations, able to guide the development of prescription processes, solve problems in development projects, guide the industrial transfer of processes;
3. Familiar with regulations and guiding principles of consistency evaluation and registration application, able to guide the registration and application of preparations;
4. 5 years experience in technical team management.
Liquid preparation process manager - Job details
1. Literature research, prescription process design and research, research and amplification of liquid preparations;
2. Responsible for the transformation from small-scale research to pilot-scale production;
3. Solve common problems encountered in small-scale research and pilot-scale production;
4. Circumvent the preparation technology, able to write invention patents;
5. Write registration application materials;
6. Maintenance and management of preparation research and development equipment to ensure use of the equipment.
1. Bachelor degree or above, 5 years work experience; Master degree with 4 years work experience, pharmaceutical engineering, pharmaceutical preparations, preparation major;
2. Liquid preparation research and development experience or pharmaceutical factory production experience, able to consult literature;
3. Familiar with chemical drug development and technical requirements, familiar with registration application materials;
4. Good communication and collaboration skills;
5. Familiar with the development process of pharmaceutical preparations and drug administration information;
6. Familiar with office software.
Injection project leader - Job details
1. Responsible for process development and production scale-up of injection products in accordance with requirements of injections, including small water injections, large infusions and freeze-dried powder injections, solve problems in production scale-up, complete the production Technology transfer, batch production, provide technical support for commercial batch production.
2. Document review and technical support of injection products, topic opening, research and development, process amplification.
3. Training of injection regulations, professional knowledge and skills, production line and production process.
1. Bachelor degree or above in pharmacy major;
2. 3 to 5 years experience of injection products research and development, production scale-up in large pharmaceutical companies , experience of overseas pharmaceutical company is preferred;
3. Familiar with the process and technology of GMP of injections, ability to solve quality problems of injection production process and products;
4. Familiar with international (including ICH, FDA and EMA) guidelines, domestic drug technical review requirements, drug registration regulations;
5. Active dedication, initiative, sense of responsibility; good communication, reading and writing skills in English.
Prescription and Biology Researcher - Job details
1.Familiar with preparation technology, large-scale production, corresponding regulations:
2.Able to identify biologically media.
3.Able to model dissolution data, model IVVIC/ IVIVR
4.Modeling experience, able to simulate clinical data, process pre-BE/BE data analysis.
5.Able to use Gastroplus, PK Sim, Simcyp and other software to process PBPK models.
1. Doctor or master in prescription, biological research, 2 years work experience;
2. Able to conduct prescription development and BE research, experience of modeling and simulation; able to develop PBPK modeling.