Please send your resume to info-china@jibiotech.com

Clinical Research Associate (CRA)

Job Responsibilities:

  1. Responsible for the specific implementation and monitoring of clinical trials, to ensure that the project is carried out in accordance with national GCP requirements, test protocols and company standard operating procedures, to ensure quality control throughout the process;
  2. Knowledge of the rules and regulations related to clinical research is required;
  3. Responsible for collating and improving all test documents and materials, ensuring the proper storage and archiving of test documents, drug release and destruction;
  4. Inspect and report the progress and quality of the test, the completion of the informed consent form and the case report form, the use of the test drug, the adverse drug reaction, etc., identify problems, analyze problems, propose solutions and implement;
  5. Tracking adverse events and serious adverse events during the trial study to protect the rights and interests of the subjects;
  6. Conduct on-site audits on a regular basis, summarize and submit audit reports, fill in relevant reports and test records to ensure that the data is true, accurate and complete;
  7. Coordinate communications between research centers and data management personnel to cultivate and maintain good relationships;
  8. Complete other tasks assigned by the superior.

Job requirements:

  1. Master’s degree or above, graduated in medicine, pharmacy, nursing or related fields, with more than 1 year of clinical research experience;
  2. Good organization, communication, coordination, problem-solving skills, creativity and teamwork, able to work in a stressful environment;
  3. Good professional written and oral communication skills;
  4. Have good professional English skills.

Working location: Shanghai (full-time)

 

Medical Director

Job Responsibilities:

  1. The day-to-day administrative work of the medical affairs, including the management of the internal departments and coordination and cooperation with various functional departments of the company;
  2. Participate in the clinical development and coordinate the initiation and conduct of Phase III clinical trials;
  3. Responsible for screening clinical trial institutions, evaluating the testing institutions, costs, time, etc., liaising with the research base to organize the implementation of clinical programs;
  4. Guide CRA, responsible for managing various materials for clinical trials, including drug supply and CRF management; responsible for the establishment and management of clinical trial master documents, and regularly updating all trial databases to ensure accurate information;
  5. Responsible for registration, reporting, and establishment of a quality system for clinical research; when implementing and advancing the company’s product pipeline strategic plan, ensure that the development plan meets the quality and safety standards required by patients, health care providers, and regulatory agencies;
  6. Responsible for the recruitment, training and management of the employees; lead the research team to ensure that the trials are completed in accordance with time expectations and budgeted costs;
  7. Regularly conduct internal meetings of the team to inform the trial progress and existing problems, and report to the superiors;
  8. Establish and maintain relationships with key physician experts, academic leaders, and maintain alignment with the company’s business plans and development goals;
  9. Regularly collect research information on the latest new drugs domestic and abroad to assist the company in strategic investment in pharmaceutical projects.

Job requirements:

  1. With a background in clinical medical oncology, the background of blood system diseases is preferred;
  2. Strong global thinking, analysis, judgment, decision making and problem solving skills;
  3. A team leader, with good organization, communication, coordination, problem solving and leadership skills, creative and team spirit, able to work in a stressful environment;
  4. Good professional written and oral communication skills;
  5. Have good professional English skills.

Working location: Shanghai (full-time)

 

Regulatory Affairs Specialist

Job Responsibilities:

  1. Provide comments and suggestions for the drug development strategy plans and participate in the evaluation;
  2. Consult and collect expert opinions and feedback to the project teams;
  3. Proposals for data preparation, registration submission and approval time for new drug development plans; make plans and timetables for developing new clinical trials or listing applications;
  4. Organize and lead team members to complete the preparation, review, submission, tracking and approval of IND and NDA registration materials, and support and assist team members to solve problems in the registration process;
  5. Organize and promote the preparation, coordination, advancement, and completion of registration inspection, GCP inspection, and GMP inspection;
  6. Plan, prepare and organize CDE communication meetings and expert consultations;
  7. Conduct team assignments, job assessments, project management, goal setting and performance evaluation, and monitor vacation and compliance;
  8. Comply with the requirements of national drug regulatory regulations and guidelines;
  9. According to the project objectives of the registration department, formulate the annual budget of the project and implement reasonably;
  10. Establish good communication channels and relationships with relevant drug administration departments and within the industry, pay close attention to changes in drug administration policies that may affect and control the risks of development projects;

Job requirements:

  1. Bachelor degree or above, graduated in medicine, pharmacy or related major, received training course in new drug development system;
  2. More than five years of registration related experience, experience in (blood) tumor registration is preferred;
  3. Strong communication and presentation skills; pharmaceutical industry registration regulations, process experience; organizational coordination capabilities;
  4. Have good professional English skills.

Working location: Shanghai (full-time)