上海招聘

  

 Major Responsibilities

  

• Assists COM/ACOM/SSU Lead to develop and coordinate to manage the study budget, accruals and actual cost, coordinate with CTA & CRA ensures study payments are paid on time

  

• Assists COM/ACOM/SSU Lead to develop study documents and other materials
• Coordinates vendor selection (CRO, translation, printing, travel agency, etc.) and management
• Supports TMF related work both paper and electronic Trial Master Files (eTMF) and study SharePoint, conducts eTMF QC if needed
• Supports PFDA document filing, CDE posting, CHGRAO submission, and ensures required documents are submitted to relevant functions/websites
• Assists COM/ACOM/SSU Lead to organize study team meetings, including meeting room booking and setup, meeting minutes taken is required; Provides enough logistic support for investigator meetings

  

• Coordinates with Clinical Supply Chain regarding drug forecasting and supply

  

• Coordinates with various system account apply and management
• Prepares and maintains various study tracker/metrics

  

Qualification

  

• Bachelor’s level degree or above in life sciences, English and management

• Fluent in English (listening, writing)

• Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines

• 3 years (PMA), 5 years or above (Sr. PMA) of CTA/PMA or clinical trial experience in the Pharmaceutical or CRO industry

• Excellent communication and interpersonal skills

百济神州是一家植根中国的全球性商业化生物医药公司，致力于成为分子靶向药物和免疫肿瘤药物研发，及商业创新领域的全球领导者。
2017年，百济神州与新基公司达成战略合作伙伴关系，向新基转让了tislelizumab在美国、欧洲、日本和亚洲以外的其他地区的实体瘤开发和商业化的独家权益，保留了在亚洲（除日本外）开发和商业化tislelizumab用于治疗实体瘤的权益，以及用于治疗恶性血液肿瘤和进行内部组合疗法的全球范围权益。

此外，百济神州获得了新基公司在华获批药物——注射用白蛋白紫杉醇（ABRAXANE？）, 瑞复美（REVLIMID？）和 维达莎（VIDAZA？）的独家授权，并接管其在华商业运营团队。

2018年1月，百济与Mirati公司sitravatinib在亚太地区的独家授权协议，进一步拓宽了公司的产品组合。

截至目前，百济神州在全球各地拥有超过1100名员工，其中包括在中国、美国、澳大利亚和瑞士的超过650名科学家及临床医学专家。

公司在中国的北京、上海、美国的马萨诸塞州Cambridge，新泽西州Fort Lee和加利福尼亚州旧金山Emeryville和San Mateo，瑞士的巴塞尔均设有办事机构。除此之外，百济神州在中国大陆还拥有位于北京的研发中心，苏州、广州两大生产基地，以及在上海的商业运营中心。