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Duties & Responsibilities:
·Responsible for tracking, analyzing, and evaluating preclinical toxicology - related literature and cutting - edge technologies to provide a scientific basis for project decision - making.
·Lead the design of general toxicology study protocols, coordinate the research process, interpret data, and write reports, ensuring the entire research process complies with GLP (Good Laboratory Practice) standards and scientific requirements.
·Responsible for providing sound business support and conducting technical communications with foreign clients or experts.
·Responsible for organizing the writing and review of the preclinical toxicology section of IND application materials (both in Chinese and English) to support domestic and international registration and application work.
·Track updates to domestic and international (including FDA, NMPA, ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use)) toxicology - related regulations and guidelines, promptly organize internal sharing and training, and promote the continuous optimization of the technical system.
·Responsible for providing effective technical support to the client (contract giver) regarding preclinical R&D issues and other related matters.
Experience Requirements - Knowledge, Skills, & Abilities (KSAs):
·Master's degree or above in toxicology, pharmacology, or other related biomedicine fields.
·with more than 5 years of preclinical GLP toxicology work experience. Candidates should have rich experience in delivering projects for foreign clients and conducting technical communications with them, and those who have worked in overseas CRO (Contract Research Organization) companies will be given priority.
·Possess strong literature research and summary capabilities.
·Excellent written and oral communication skills in English as a must,and conduct technical communications in fluent English.
·Familiar with relevant toxicology research guidelines and GLP regulations of FDA, NMPA, ICH, etc.
·Have a systematic grasp of preclinical toxicology evaluation processes and study design methods.
·Possess strong learning and integration abilities, communication and coordination skills, team spirit, and a strong sense of responsibility.