1. responsible for writing, reviewing and revising medical documents related to clinical research projects (ICF, CRF).
2. provide medical support for clinical study related meetings, including but not limited to protocol seminars, ethics meetings, kick-off meetings, expert consultation meetings, data review meetings and project summary meetings.
3. Conduct regular medical verification and summarize common problems to form guidance documents, and be responsible for monitoring and evaluating the clinical implementation status to ensure that the clinical trials are conducted in accordance with the requirements of the protocol.
4. Provide medical support and quality control for clinical operations, including screening and enrollment and answering medical questions during the clinical study.
5. Communicate with internal and external medical affairs, including statistics, central laboratories, CROs, and internal and external communication and medical communication.
6. conduct medical procurement for clinical trial implementation and maintain and follow the rules and procedures.
7. conduct medical affairs such as meeting booking, personnel invitation;
8. perform quality control of medical documents and processes in the conduct of clinical trials.
9. collect and archive medical documents generated from clinical trials.
1. Master's Degree of Medicine in Clinical Medicine, Pharmacy related field.
2. 3-5 years of relevant work experience in medical support in the field of self-exemption in pharmaceutical companies.
3. good command of medical English, able to read and translate medical literature with high quality.
4. strong communication and coordination skills, ability to take the initiative to learn and teamwork spirit, work conscientiously, strong sense of responsibility.
1. responsible for leading medicinal chemistry R&D team to discover, design and optimize lead compounds;
2. Work with the team to develop screening criteria and plans to screen PCCs;
3.Responsible for the management of the R&D team, team building, team performance appraisal, establishment of relevant processes and SOPs;
4.Responsible for planning the progress of relevant drug discovery projects and rationally utilizing internal resources and outsourcing services;
5.Adjust the direction of R&D according to the progress of drug development projects and the results of in vivo and ex vivo experiments;
6.Responsible for tracking the progress of the global drug R&D frontiers, and providing evaluation opinions on the company's project establishment and advancement;
7.Other related work in medicinal chemistry research and development.
1.PhD degree in organic chemistry, medicinal chemistry and pharmaceutical engineering, with 5 years or more experience in small molecule new drug medicinal chemistry research and development and project management, overseas experience or multinational pharmaceutical companies is preferred;
2.Able to independently undertake the research and development of projects, including tracking, analysis and review of relevant literature and patents, drug design, synthetic route design, etc.; able to use computer software for assisted design is preferred;
3.Strong ability to analyze and solve the problems in the development of new drugs, including the rapid synthesis of compounds and optimization of problems in the process, make a more comprehensive analysis of the results, and good at summarizing;
4.Ability to skillfully interpret and analyze pharmacological, pharmacokinetic and toxicological data, and use them as a guide to optimize compounds;
5. Good organizational and coordination skills, project management and team leadership skills, able to lead and train team members to work productively as a team;
6. Good communication skills in English and Chinese, responsibility, initiative and teamwork spirit.
1.According to GCP, project requirements and the company's SOP, to assist in the clinical trial process;
2.Assist in the preparation and submission of clinical trial project documents; responsible for the daily management of project documents, maintenance and updating of folders, to ensure the accuracy, completeness and timeliness of the recovery of the documents;
3.Assist in the clinical trial project materials, drugs, supplier management, etc.;
4.Organization and support of the project Organize and support project meetings, investigator meetings, etc., and record meeting minutes, and assist in updating the project tracking form on a regular basis;
5. support the contract and expense management in the clinical trial project;
6.support the project team in handling project affairs and internal and external departmental communication;
7.complete the other work assigned by the supervisor.
1. unified enrollment college degree or above, medicine, nursing, medicine, biology and other related majors;
2.has a clinical research related post work experience is preferred;
3.familiar with IT software, such as Microsoft Word Excel;
4.good English listening, reading and writing skills;
5.strong work initiative, learning and adaptability; good team, cross-sectoral spirit of cooperation;
6.good with the Good communication with others, good sense of service, strong adaptability and the ability to analyze and solve problems.