长沙招聘

 Develops or reviews regulatory strategy and action plan for internal or external projects. Provides advises consults in the area of expertise both internally and to clients. Prepares or reviews regulatory dossier and ensure timely submission in compliance with regulations guidelines and SOPs. Resolve any issue timely to ensure earliest possible registration. Keeps abreast of current data trends regulatory knowledge developments and advances in the China and global regulatory environment. Ensure any potential impact to projects or company business have been thoroughly well communicated. Manages and coordinates resources and reviews workload for all direct reports. Guide and support staff to improve knowledge and skill continuously. Reviews performance and provide counseling for direct reports Provides support to Business Development Interacts with internal andor external clients. Identifies and responds appropriately to issues providing adequate andor innovative solutions. Identifies project needs and scope of work creates project timelines and implements client requests seeking clarification and senior review as necessary. Works with minimal direction identifies project needs creates project timelines and tracks project budgets (where appropriate) for multiple projects and revises and manages scope of work changes when necessary. May serve as Project Manager or technical lead on a regulatory project. Build up and sustain a reliable and professional relationship with regulatory authorities (e.g. CFDA CDE NICPBP Provincial FDAs Drug Control Institutes). 任职要求： Undergraduate degree or above in medical science or related life sciences area. Over 6 years of regulatory experience in a global leading pharmaceutical company or CRO. Ability to exercise independent judgment in developing effective resolutions to problems in a regulated environment. Must demonstrate abilities in scientific knowledge and its appropriate application to regulatory issues. Extensive knowledge of regulations relevant to the area of expertise. Ability to work on several projects at once while balancing multiple timelines (i.e. overlapping timelines on one or more projects). Ability to communicate effectively in both oral and written modes. Ability to communicate at multiple levels in the organization and in difficult situations. Must have careful attention to detail and accuracy. Open attitude and willing to meet challenges. Must possess strong negotiating skills.

PPC佳生集团（PPC Group）是一家成立于1997年的临床CRO公司。总部设立于上海，并分别在台北，徐州，北京，南京，首尔及东京设立了分部及分公司。
     自成立以来我们始终致力于为国内外制药企业及生物技术公司提供专业的临床研究服务及生物样本分析服务。至今，PPC佳生已经完成了超过3000项早期临床试验项目及超过500项II期至IV期临床试验项目，其中涉及24个主要研究领域。
     另外，PPC佳生的I期临床中心及生物分析实验室也分别通过了美国FDA,中国NMPA,台湾TFDA,日本PMDA,欧盟EMA及马来西亚NPRA等的核查。
     2012年，PPC佳生在台北（MacKay Memorial Hospital）建立了***家专属I期临床研究中心；2017年初与徐州医科大学合作共同建立了徐州医科大学附属医院I期临床研究中心；2018年，PPC佳生又分别与徐州市中心医院，湖北省鄂东医疗集团黄石市中心医院以及上海市浦东新区人民医院共同建立并开设了三家专属的I期临床研究中心。截至目前，PPC佳生已有5家自主运营的I期临床中心。