According to the company's quality management requirements, establish the company's quality system and carry out supervision.

Responsible for the establishment, implementation and maintenance of the company's quality system to ensure the effective operation.

Establish quality management policies, corresponding quality objectives, and monitor the implementation.

Compile quality system documents, supervise the implementation and daily management of those documents.

Responsible for monitor the quality of company's products in the research and development process, and participate in the handling of quality risks and accidents of the company (including CDMO).

Responsible for organizing quality trainings to employees.

Evaluate the supplier’s quality system with the relevant departments and select the suitable supplier.

Establish quality improvement plans and supervise the implementation.

Bachelor’s degree or above in biology, medicine, pharmaceutical engineering, pharmacy, biological engineering and other related majors.

At least 5 years of relevant work experience. Familiar with biopharmaceutical quality management system and GMP.

Experience in working in QA departments of biopharmaceutical or CDMO company.

Familiar with the corresponding policies, laws and regulations of biologics quality system in China and abroad, familiar with GMP, IND and NDA submission.

Extensive experience of using quality management tools.

Candidates with GCP QA would be preferred.

Strong independent thinking and analytical skills.

Teamwork spirit and good communication skills.

Good English listening, speaking, reading and writing skills.

Good work ethics and risk awareness.

Familiar with the GCP, ICH-GCP, etc.

Responsible for the writing of all IND and NDA submission materials, for example, Protocol, IB, CSR, etc.

Responsible for the writing of research-related publications.

Responsible for the literature search and medical writing support in the process of the clinical trial operation, participate in the discussion on the clinical study design.

According to the the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and other guidelines, complete the medical writing of the milestones achieved.

Ensure appropriate quality control (QC) check on CSR, other regulatory documents, and other medical writing deliverables as needed, collaborating with biostatistics and clinical colleagues to interpret research findings.

Master's degree or above in medicine, pharmacy or life sciences.

At least 2 years of relevant experience.

Knowledge/experience in pharmaceutical companies in writing compliant research reports or medical management documents in line with ICH E3 as a medical author, a good understanding of ICH guiding principles and regulatory requirements, and able to interpret and apply these guidelines in report writing.

Familiar with the full lifecycle of clinical research and fully understand each stage of clinical research.

Strong communication skills, sense of teamwork.

Proficient in the use of Office software, familiar with tools and search engines to find scientific information.

Strong written and oral communication skills in both Chinese and English.

Familiar with the GCP, ICH-GCP, etc.

Responsible for the medical monitoring and medical data review of clinical research projects, and responsible for the resolution of medical-related issues in the whole process of the project to ensure the smooth progress of clinical trials and in compliance with the relevant laws and regulations of the country and the interests of the company.

Responsible for developing the medical monitoring plan reviewing medical data, monitoring safety-related information,and handling protocol deviations. Provide support on the medical review of screening , enrollment and drop out of subjects in clinical trials.

Participate in the writing of clinical research materials for CDE communications and medical writing for IND submission, Organize and co-ordinate the writing and review of medical documents for NDA submission.

Participate in the design of clinical protocols; Contribute to the medical/scientific input given for the development of trial-related documents such as IB, ICF,CRF etc.

Attend investigator conferences, project kick-off meetings and provide medical support as needed.

Conduct medical training and provide medical support to other departments as needed.

Master's degree or above in Clinical Medicine or related.

At least 2 years of experience as a clinician or medical manager of a pharmaceutical company or a CRO company.

Familiar with the full lifecycle of clinical research and fully understand each stage of clinical research.

Familiar with the GCP, ICH-GCP, etc.

Good communication, co-ordination and project management skills.

Strong written and oral communication skills in both Chinese and English.

Proficient in the use of Office software, familiar with tools and search engines to find scientific information.

Understand and keep track of the development dynamics of Antibody-drug Conjugate (ADC) drugs in China and abroad. Design novel small-molecule compounds, especially the organic synthesis reaction between linkers and payloads.

Proficient in designing and completing chemical reactions and conduct scientific and comprehensive analysis of experimental results.

Responsible for laboratory-scale separation and purification to obtain target compounds of the required purity.

Responsible for laboratory, personnel and equipment management.

Complete the writing and management of experimental records and project reports as required.

Other duties as assigned.

Master’s degree or above in Organic Chemistry, Medicinal Chemistry and other related chemistry with good basic theoretical knowledge.

2 years of scientific research or work experience in the fields related to organic synthesis and drug synthesis; Preferably experience in the design and synthesis of ADC linkers.

A good command of English

Proactive with a positive attitude and a strong sense of responsibility.

Good communications skills.

Hardworking and able to work under high pressure.

Good team-work spirit and coordination skills.