IND-enabling Program Management 上海

月薪： 1-2万/月

该公司所有职位
  • 2年经验
  • 招若干人
  • 英语熟练
  • 11-09 发布

职位描述

职位描述： Title: IND-enabling Program ManagementDepartment: WuXi Biologics TAD Innovative drug pre-clinical development groupScope of responsibility: Project management and TOX expert responsibility:1.Manage, direct and lead preclinical projects in a team environment; Work with clients to proactively identify the right strategy based on their unique program and help clients to select right studies, smartly coordinate the studies to move forward efficiently2.Monitor closely the progress of the project, coordinate with sponsors and internal expertise to design appropriate studies to meet regulatory requirements, ultimately to meet the project needs. Stay on the top of project with continues scientific and technical support. Proactively identify potential issuers and input the constructive suggestions3.Interact with clients, other key functions/business units within WuXi AppTec to facilitate the project development; Communicate directly (visiting host, holding TC and auditing, etc.) with national and international sponsors4.Service as an expert for all TOX-related discipline within TAD; Prepare documents package for IND filing; Search and prepare scientific references for project needs.5.Initiate issue-oriented agendas to facilitate effective team meeting discussion and able to summarize and provide guidance on follow-up strategies to ensure timely resolution of outstanding items.Qualifications and Skills:1.PhD or equivalence in biomedical/ pharmaceutical science with at least 5 years experience in pharmaceutical/biotech industry in preclinical development with strong toxicology expertise.2.Demonstrated successful leadership, planning and organizational skills with strong knowledge in pharmaceutical R&D from discovery to clinical development and regulatory registration;3.Familiar with relevant FDA, ICH, EMA/OECD and CFDA guidelines/regulation with hands-on experience on planning and execution of IND/CTA programs4.Team oriented work ethic and ability to work in cross-functional teams5.Excellent written and oral communication skills6.Regulatory writing experience and PMP certification will be a plus 职能类别： 生物工程/生物制药

联系方式

上海市外高桥保税区富特中路288号

公司信息

药明生物（WuXi Biologics）是香港上市公司（代码：2269），我们是全球领先的开放式、一体化生物制药能力和技术平台，旗下包括无锡药明康德生物技术股份有限公司、上海药明生物技术有限公司、苏州药明康德检测检验有限责任公司，并在美国和英国设有子公司。公司为全球生物制药公司和生物技术公司提供全方位的端到端研发服务，帮助任何人、任何公司发现、开发及生产生物药，实现从概念到商业化生产的全过程，加速全球生物药研发进程，降低研发成本，造福病患。目前，公司规模达到2300多人，有200多位拥有海外高等学位和工作经验的海归科学家，拥有丰富的欧美市场抗体开发、生产、质量控制、临床前研究和注册的经验，打造了世界一流的生物药研究、开发及生产团队。 更多信息，请登录公司官网：http://www.wuxibiologics.com.cn/

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企业入驻日期： 2017-11-09

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