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毒理专题负责人(SD)-新药
2-3万
人 · 硕士 · 9年及以上工作经验 · 性别不限2025/01/09发布
五险一金绩效奖金补充医疗保险餐饮补贴年终奖金弹性工作专业培训定期体检节日福利

郭巷街道吴淞路818号

公司信息
苏州方达新药开发有限公司

外资(非欧美)/50-150人

该公司所有职位
职位描述
工作职责:

1.按照GLP相关法规的要求负责专题研究工作的方案设计、撰写实验方案、组织实施、结果分析并撰写总结报告,以及实验文档、标本、样品归档保存等全过程;
Responsible for the whole process of study design, study protocol preparation, study organization and implementation, result analysis and summary report writing, and archiving of study documents, specimens, and samples in accordance with the requirements of GLP related regulations.

2.制定实验方案(毒理、安全药理等)及协作计划,确保参与试验的相关人员明确所承担的工作内容、日程及相应标准操作规程;
Develop study protocol (toxicology, safety pharmacology, etc.) and working calendar to ensure that the relevant personnel involved in the study are clear about the work content, schedule and corresponding SOPs;

3.如需要,及时提出修订或补充相应标准操作规程的建议;
Promptly propose to revise or supplement the corresponding SOPs, if needed;

4.掌控实验进程,确保各种实验记录及时、真实、清晰、完整,保证专题研究工作的质量;
Control the study process, ensure that various experimental records are timely, actually, clear and complete, and ensure the quality of the study;

5.详细记录实验中出现的意外情况和采取的措施;
Record in detail the unexpected situations and the measures taken in the study;

6.及时处理质量保证部门提出的问题,确保研究工作各环节符合法规要求;
Respond the questions raised by the QA department in a timely manner to ensure that all aspects of the study meet the requirements of laws and regulations;

7.负责与委托方沟通试验进展,讨论实验相关问题;
Responsible for communicating with the client about the progress of the study and discussing related questions about the study;

8.负责毒理部项目分配给合适的SD,确保新签订单能够及时运行
Responsible for the project assignment to the appropriate SDs in the toxicology department, ensure that the new orders can be run timely.

任职资格:
1.根据需要参与新员工的培训;
Participate in the training of new employees as needed;

2.协助人事进行校园招聘;
Assist HR in campus recruitment;

3.协助BD团队,与客户进行业务沟通;
Assist the BD team to communicate with customers;

4.参与公司的各项认证工作
Participate in various certification and accreditation works of the company.

REQUIREMENTS (WORK EXPERIENCE, EDUCATION AND OTHER)
岗位要求(工作经验、学历背景和其他)
1.具有硕士及硕士以上学历且具有10年以上安全性评价研究工作经验;
Have a master's degree or above and have more than ten years of work experience on safety evaluation research;

2.有药理学、毒理学、病理学、兽医学、临床医学或者相关专业背景;
Have pharmacology, toxicology, pathology, veterinary medicine, clinical medicine or related academic background;

3. 熟练掌握一般毒理试验的各项操作技能,接受过相关专业培训,具有较强的分析问题和解决问题能力;
Familiar with the various experimental skills of general toxicology tests, have received relevant professional training, and have strong problem analysis and problem solving skills;

4. 有较强的实践经验和组织能力,曾负责或者参加过多个一般毒理/遗传毒理的研究工作;
Have strong practical experience and organizational skills, have been responsible for or participated in a number of general toxicology/genetic toxicology research work;

5. 熟悉NMPA、FDA和OECD的GLP法规和指导原则,能够根据法规要求推进试验;
Familiar with the GLP regulations and guidelines of NMPA, FDA and OECD, and be able to implement the study according to the requirements of the regulations;

6.具有良好的敬业精神、规范意识及较强的组织协调和沟通能力;
Have good professionalism, awareness of regulations and strong organizing and communication skills;

7. 英语基础扎实,有较强的外语理解能力和表达能力;
A solid foundation in English, strong foreign language comprehension and expression skills;

8. 熟练掌握办公软件。
Familiar with office software 。

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