公司：外资医药生物科技公司
工作地点：武汉
Job Responsibilities：
Contribute to and implement an overall drug development strategy to support nonclinical and clinical pharmacology development during all stages of drug development.
Manage JHL biologics nonclinical programs. Design, implement, report and interpret nonclinical study data of biologics.
Prepare study synopsis, protocols, study reports and regulatory documents to support nonclinical development of JHL’s drug candidates.
Interact/collaborate with JHL functions, CROs, business partners, as necessary to ensure appropriate/timely progression of JHL projects.
Effectively communicate nonclinical findings and their relevance to senior management, project teams, collaborators, and regulatory agencies (i.e. FDA, EMA, NMPA).
Participate in multi-disciplinary drug development teams and may lead sub-teams.
Excellent written and verbal communication skills. Ability to build/foster productive cross-functional collaborations both within and external to JHL.
Job Requirements:
Master degree or above in Pharmacology/Toxicology and 8 years’ experience in the pharmaceutical or biotechnology field.
Experience supporting the development of biologics and biosimilar, including determining non-clinical program strategy and design. Experience with the preparation of global regulatory submissions (IND/CTDs, NDA/BLA, etc.) and communicating/interacting with health authorities highly desirable.
Experience in the design, conduct, and interpretation of GLP and non-GLP nonclinical pharm/toxicology studies.
Strong understanding of drug development and regulatory process, as well as a strong understanding of global Good Laboratory Practices (GLPs).
Strong critical, scientific, and strategic thinking skills; Strong problem solving and decision making abilities.
Strong communication in Chinese and English (verbal and written) skills.
简历可发至：wanco@wanco.com.cn，并写上要应聘的职位名称。
上海万谷境外就业服务有限公司
Shanghai Wanco Overseas Employment ServiceCo., Ltd
电话：+86-21-62946951/62946952
网站：www.wanco.com.cn
邮箱：wanco@wanco.com.cn
QQ: 800066950(搜服务)
微信号：wancoshanghai
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