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Human Resources

人力资源

Kintor Pharmaceutical is looking forward to your participation!

If you have passion and interest in joining us, please mail your resume to kintor-HR@kintor.com.cn.

Registration Manager Discussed personally SuZhou 立即申请
Registration Manager

Job responsibilities:

1. Be responsible for communicating with entrusted research company, following up the study progress, and supervising the research company’s work and raising technical requirements according to the requirements of real-time registration regulations;

2. Be responsible for compiling a part of application data, reviewing the registration data compiled by the entrusted research company, and feeding back and supervising the modification of such data;

3. Be responsible for sorting and handing in the registration data, tracking the progress of registration, and timely feeding back and coordinating the solving of review and approval issues;

4. Organize communication with CDE as required, and compile and submit communication data to CDE;

5. Be responsible for international registration management of existing projects, comprehend and learn international registration requirements, communicate with registration agencies, and track and manage registration affairs;

6. Timely track, get familiar with and interpret the relevant laws and regulations related to drug research of NMPA and CDE, search the dynamic progress of industry regulations, and offer training and policy support to the drug study teams.

Job requirements:

1. Be familiar with the whole process of drug R&D and regulations related to drug registration;

2. Good communicating and coordinating ability, meticulous and patient working attitude, and active and initiative professional dedication;

3. Have more than 5 years’ work experience in drug registration application, and good connections for drug registration. Those with work experience for registration management in large pharmaceutical companies are preferred;

4. Good Chinese and English writing ability. Those with English reading ability are preferred;

5. Those who have the experience of submission of CTD data to ANDA or NDA and successfully acquired approvals are preferred.

 

Bulk Drug Project Manager Discussed personally SuZhou 立即申请
Bulk Drug Project Manager

Job responsibilities:

1. Be responsible for CMC project management work of bulk drugs and preparations;

2. Be responsible for selecting CRO and CMO companies, signing contracts, following up projects and summarizing project progress;

3. Be responsible for accepting project requests inside the company, organizing the relevant personnel to communicate project requirements, and making clear of project goals;

4. Be responsible for approving, tracking, updating and closing CMC projects;

5. Be responsible for organizing the relevant project leaders to formulate and update project timetable to ensure the realization of project goals;

6. Be responsible for summarizing project progress on a regular basis, organizing CMC internal regular project meetings and meetings with other departments, and completing meeting minutes;

Job requirements:

1. Work experience in R&D and production of bulk drugs and preparations of new drugs or generic drugs; those with experience in whole CMC process of bulk drugs of new drugs and generic drugs are preferred;

2. Professional knowledge in the R&D fields of new drugs or generic drugs especially professional foundation in terms of drug chemistry and preparation, strong learning ability, and work initiative and sense of responsibility;

3. Those with project management related experience are preferred.

 

Clinical QA Manager Discussed personally SuZhou 立即申请
Clinical QA Manager

Job responsibilities:

1. Develop, maintain and execute an effective clinical quality management system, review the SOP of each flow of the department as well as clinical study related documents, and ensure integrity, correctness and regulatory conformity;

2. Check the implementation of the quality policy system and ensure the conformity of implementation of the whole process of clinical trial to the trial protocol, SOP and GCP;

3. Be responsible for discovering and tracking quality problems in the clinical study and supervising and urging the solving of such problems;

4. Ensure the readiness of audit/inspection of clinical activities and assist a third party/drug supervision agency in auditing/inspecting the company or site; follow up the replies to audit reports and track the implementation of audited problems;

5. Participate in the evaluation, certification, screening, optimization and other relevant work of existing and new suppliers (CRO, SMO, central laboratory, etc.);

6. Be responsible for auditing all documented records of clinical trial and managing the archived clinical data;

7. Be responsible for studying and tracking domestic and foreign policies and regulations and managing the training of clinical study system.

Job requirements:

1. Bachelor’s degree and above, majoring in clinical medicine, or pharmacy;

2. More than 3 years’ clinical study work experience and QA experience;

3. Familiarity with each standard operating procedure (SOP) regarding clinical trial, GCP-ICH and other domestic and foreign regulations;

4. Familiarity with each process of drug clinical trial as well as process and method of clinical audit.

 

Clinical Research Associate/CRA Discussed personally SuZhou 立即申请
Clinical Research Associate/CRA

Job responsibilities:

1. Be responsible for monitoring the enrollment progress of the site, quality of clinical study and coordination of clinical trial work, and ensuring the implementation of the clinical trial in strict accordance with the requirements of the relevant regulations like GCP and the trial protocol;

2. Be responsible for verifying the filling of CRF, confirming that all AEs are recorded, reporting and recording SAEs within prescribed time limit, timely spotting the problems in the trial, communicating with and reporting to the clinical study manager, and submitting monitoring reports;

3. Participate in the screening and survey of clinical trial sites, and establish contact with the site and maintain it;

4. Participate in the completing of study related contract signing, payment, and sealing of clinical summary report;

5. Participate in the organizing of meetings in each stage of clinical trial;

6. Participate in the selection and management of suppliers (SMO, central laboratory, etc.);

7. Complete other work arranged by the superior.

Job requirements:

1. Bachelor’s degree and above, majoring in medicine, clinical medicine, or nursing; more than 1 year’s work experience, more than half a year’s CRA work experience or more than one year’s CRC work experience;

2. Working initiatively and earnestly with strong executive force and relatively strong coordinating and communicating capacity;

3. Familiarity with clinical trial related regulations.

 

Medical Monitor Discussed personally SuZhou 立即申请
Medical Monitor

Job responsibilities:

1. Participate in the protocol design and execution of clinical trial as well as audit and analysis of subjects’ clinical data;

2. Be responsible for communicating with investigators and study unit to pick suitable subjects and handling affairs related to clinical study regarding drug use and review and management of adverse event reporting;

3. Manage and conduct quality control over the clinical trial and ensure the conformity of clinical trial to the requirements of GCP/ICH and FDA related regulations;

4. Develop SOPs for the clinical trial and offer training to clinical operation team, CRC, CRA, etc.;

5. Participate in and discuss the latest progress of domestic and foreign clinical studies and therapies on a regular basis;

6. Actively complete other work tasks delivered, e.g. support for the medical part of registration materials, prepare the contents for participation in communication with CDE, and attend meetings.

Job requirements:

1. Bachelor’s degree, master’s degree or doctor’s degree in clinical medicine or related major; those with master’s degree or doctor’s degree are preferred;

2. Those with study experience as tumor clinician are preferred;

3. Those with clinical project management experience are preferred;

4. Working initiatively, carefully and responsibly with good interpersonal communicating and coordinating ability and teamwork spirit;

5. Rigorous scientific research thinking and logical analysis capacity.

 

QA Supervisor Discussed personally SuZhou 立即申请
QA Supervisor

Job responsibilities:

1. Be responsible for communicating with consulting company, establishing a quality system of the company, and forming and timely updating R&D, inspection and production SOP documents;

2. Be responsible for the suitability of SOP documents for the actual conditions of the company, and offer training for implementation of such documents;

3. Be responsible for supervising the execution of SOPs and ensuring that the various documents of the company are drafted according to stipulated templates and quality manual and SMF documents of the company are well executed;

4. Be responsible for reviewing various documents of the company and ensuring the conformity of post-approval issuing, execution, reexamination, recycling, destruction, preservation and archiving of originals and management of storage period to the provisions of the company;

5. Be responsible for ensuring that all deviations, changes, risk evaluations and CAPAs taking place to the company are effectively handled;

6. Be responsible for joining the department personnel to complete the QA work at the manufacturer’s manufacturing site;

7. Be responsible for ensuring that the directory of the company’s eligible suppliers is well executed and the suppliers are audited;

8. Be responsible for ensuring the conformity of all sites of the company used for production and detection activities to the stipulated quality management requirements, and eliminating risk factors that constitute hazards against product quality timely and ahead of time.

Job requirements:

1. Bachelor’s degree and above, graduated from the major of pharmacy or other related major;

2. More than 3 years’ drug production or quality management experience; those with experience in quality management of biological and chemical pharmaceuticals and participation in GMP certification are preferred;

3. Familiarity with national drug administration related laws and regulations, as well as drug certification regulations of CFDA, FDA and the EU;

4. Calm and meticulous personality, strong sense of responsibility and strong working principles;

5. Relatively strong organizing and managing ability and good communicating skills and team spirit;

6. Those with relatively strong Chinese and English writing ability are preferred.

 

CSV Verification Supervisor Discussed personally SuZhou 立即申请
CSV Verification Supervisor

Job responsibilities:

1. Be responsible for the construction of quality system related to the verification of the company’s computerized system;

2. Formulate computerized system verification files, e.g. verification master plan (VMP)/risk assessment (RA)/verification scheme (IQ/OQ/PQ)/requirements traceability matrix (RTM)/verification summary report (VSR), etc.;

3. Participate in computerized system verification of the company’s QC laboratory (including various inspection instrument workstations, online edition of CDS system,etc.);

4. Participate in computerized system verification of the company’s workshop automatic control system (public system, SCADA system, etc.);

5. Propose suggestions on the regulatory conformity of the company’s computerized system and compile URS for the computerized system;

6. Complete the daily management work of computerized system (data backup and recovery, authority configuration, etc.).

Job requirements:

1. Junior college and above, majoring in pharmacy, computer, electric automation, etc., intention to engage in computerized system verification work;

2. More than 3 years’ work experience in quality, engineering or IT department of pharmaceutical enterprises;

3. Familiarity with the requirements of domestic and foreign regulations concerning computerized system;

4. Ability to formulate reasonable verification strategies and verification plan according to GAMP5;

5. Master basic risk assessment methods;

6. Have certain computer related knowledge, including network, application software and server.

 

Biologics Research-Doctor Discussed personally SuZhou 立即申请
Biologics Research-Doctor

Job responsibilities:

1、 Lead and champion drug discovery projects from discovery to early clinical development.

2、Develop and execute efficient strategies for target identification, prioritization and validation; review, propose, initiate, and implement new pre-clinical therapeutic antibody drug discovery and development programs in the fields of Immuno-oncology, Immuno-Inflammation etc.

3、Build, coach and manage a team of in house scientists. Collaborate with CRO and academic partners; employ cutting-edge in vitro and in vivo animal and human models to advance drug discovery and development programs up to and including IND filing.

4、Collaborate with clinical and business units to support clinical studies. Lead project team meetings, and present updates to senior management.

5、 Facilitate and/or coach team member for the writing of patents and regulatory documents.

Basic qualifications:

1. Doctor’s degree or post-doctoral in immunology or related discipline; 0-10 years’ work experience

2. Master’s degree in immunology or related discipline; more than 5-20 years’ work experience

Priorities

1. Independent critical thinking and scientific achievements in scientific researches with publications on mainstream periodicals as example;

2. Experience of leading drug discovery projects in biological pharmaceutical companies;

3. Abundant experience in immunology, oncology and molecular and cell biology;

4. Experience in disease models involving in vivo immunity, inflammation and tumor;

5. Good understanding of basic knowledge and practice concerning discovery, engineering and development of antibodies;

6. Great passion for laboratory experiments;

7. Excellent communicating ability, personnel organizing ability and team spirit, good conduct and strong sense of responsibility and entrepreneur spirit;

8. Relatively strong English communicating ability;

9. Relatively strong English writing ability and foreign literature reading ability

 

Drug Preparation Researcher Discussed personally SuZhou 立即申请
Drug Preparation Researcher

Job responsibilities:

1. Engage in preparation study work in R&D of new drug preparations;

2. Conduct experiments to evaluate medicinal properties, e.g. solubility, pKa, LogP/LogD, stability, crystal form, grain size, degree of crystallinity, etc.;

3. Assist the development of pre-clinical and clinical formulas to support pre-clinical and clinical studies;

4. Complete other work arranged by leaders.

Job requirements:

1. Master’s degree and above, majoring in drug preparation and other field;

2. Engagement in study work of new dosage forms and new technologies of drugs, possession of operation experience in new processes of preparations and new equipment, and relatively strong project operation ability;

3. Implement preparation study work according to the company’s requirements, including prescription design, process study, stability study, process enlargement, etc.;

4. Compile and sort application data and original records according to new drug registration requirements;

5. Strong English reading and writing ability and proficiency in using common office software;

6. Good communicating ability and team spirit

 

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