北京 [切换城市] 北京招聘北京生物/制药/医疗器械招聘北京医药技术研发管理人员招聘

Non-Clinical Toxicology Study Coordinator/Manager

再鼎医药(上海)有限公司

  • 公司规模:500-1000人
  • 公司性质:外资(非欧美)
  • 公司行业:制药/生物工程

职位信息

  • 发布日期:2017-03-30
  • 工作地点:上海-浦东新区
  • 招聘人数:1人
  • 工作经验:5-7年经验
  • 学历要求:本科
  • 职位月薪:5000-30000/月
  • 职位类别:医药技术研发人员  医药技术研发管理人员

职位描述

职位描述:
Job Purpose

This newly created position will contribute to all phases of monitoring and oversight of Contract Research Organization (CRO) conducted toxicology studies (GLP and Non-GLP). In addition, it will also be responsible for operations for non-clinical development including ownership of process related deliverables, review of non-clinical sections of worldwide regulatory submissions, and project management of non-clinical development projects.

Key Responsibilities

? Contracting activities including price and contract negotiations, purchase requisitions and processing of invoices and CRO scheduling and timeline updates.
? Coordinating test article supply and tracking stability testing to support each toxicology study
? Scientific oversight of non-clinical toxicology studies including protocol review/preparation and study monitoring
? Data and slide preparation for internal discussions and/or presentations as well as compiling and QC of non-clinical data tables for regulatory submission
? Writing and reviewing non-clinical sections of regulatory submissions
? Project management to ensure the delivery of timelines and milestones

Requirements

? Strong independent analytical and problem-solving capabilities, displaying creativity and innovation
? Familiar and experienced with the oversight of GLP compliant non-clinical development to support pharmaceutical and biologic drug development and have knowledge of non-clinical regulatory requirements
? Excellent oral and written communication skills as well as strong organizational skills and have the ability to work efficiently

Education:

? BS, MS or PhD degree in a biological science or related field.

Experience:

? A minimum of 3 or 5 years of experience conducting and/or monitoring GLP compliant toxicology studies in a biotech/pharma environment

职能类别: 医药技术研发人员 医药技术研发管理人员

关键字: 毒理学

举报 分享

公司介绍

Zai Lab is an innovative biopharmaceutical company based in Zhang Jiang, Shanghai focused on bringing transformative medicines for cancer, autoimmune and infectious diseases to patients in China and around the world. Zai Lab focus on innovation to meets the unmet medical needs. Zai has built up a strong pipeline with multiple programs on clinical stages. Zai Lab successfully listed on Nasdaq in Sep. 2017.

再鼎医药是一家总部设立于上海张江,致力于研究、开发和销售创新药物的制药企业。再鼎医药针对目前尚无良好治疗手段的疾病领域开发新药,在肿瘤、抗感染、自身免疫等方面建立了全面的产品线,服务中国和全球病患。再鼎医药于2017年9月在美国纳斯达克成功上市。

联系方式

  • 公司地址:地址:span上海浦东张江高科技园区金科路4560号金创大厦3号楼8楼