长沙招聘

The Clinical Inspection Readiness Leader (CIRL) is an “expert” leader responsible to lead Clinical Inspection Readiness (IR) and Pre-Approval Inspection (PAI) activities and to identify strategic solutions for continued improvement across clinical, where needed.
The CIRL is expected to consistently lead in the process for gathering, analyzing and sharing of best practices and lessons learned. The CIRL may also participate in the design, implementation and maintenance of the Quality Risk Management processes and system within the Clinical perimeter, ensuring alignment with the evolution of the regulations and business needs. He/She can also be a Clinical Quality Risk/Alert Leader for assigned risks.
Overall, the CIRL leads large transversal projects that support inspection readiness for which significant changes/improvements to business processes are expected across R&D and beyond. He/she leads via a project management approach, through optimized processes, new technologies and innovation.

职位要求：
Experience required: Minimum of at least 12 years’ experience in the pharmaceutical industry, with at least 8-10 years’ experience in GCP clinical and/or GCP quality operations-related roles (e.g., GCP auditing, clinical trial monitoring, trial management or Pharmacovigilance) AND demonstrated ability to lead complex projects/assignments.
An extensive knowledge of Research & Development with past experience in clinical operations, preferably global clinical trial management and/or GCP quality assessment/assurance.
The following skills are also of particular importance:
Experience with CFDI, FDA, EMA or other regulatory inspections of sponsor, investigator sites, or CROs Quality focused with a high degree of personal accountability and commitment Demonstrated skills in self-motivation, taking initiative and working independently.
Strong project management skills (global clinical projects
clinical process improvement projects) including:
-Results driven with attention to detail and quality while overseeing and connecting with contributing stakeholders
-Excellent team leadership, presentation, interpersonal and communication skills (written and verbal)
-Rigor, diplomacy and good analytical abilities
-Strong facilitation skills: ability to lead effective cross-location and cross-functional meetings, through discussions on complex and potentially controversial topics.
-Demonstrated ability to bring consensus among diverse cross functional teams and to drive results within established timeline
-Demonstrated ability to anticipate problems/ changes impacts, consequences, and delays
work proactively and take the initiative for corrective measures.
-Ability to multi-task, handling a wide range of small, medium and long-term assignments in parallel and dealing with urgent issues as they arise with ability to prioritize assignments in accordance with assigned project deadlines.
Strong knowledge of international good clinical practices (ICH) and understanding of current regulatory requirements (FDA, EMEA) related/ applicable to the conduct of clinical trials, understanding of FDA Compliance Manual & EMA Compliance Manual.
Knowledge about requirements of New Drug Application (NDA)/ Market Authorization Application (MAA) submissions and e-submissions Strategy focused with ability to extrapolate detail without losing sight of big picture.
Ability to analyze trends and determine strategic improvement needs
ability to execute and monitor the implementation and progress of such improvement processes.
Competent in English (both written and verbal) to interact effectively in an international environment.

赛诺菲集团
赛诺菲集团是一家全球领先的多元化医药健康企业，专注于患者需求，传播健康。
 全球100,000余名员工，业务遍及100个国家
 新兴市场实力均衡，表现强劲，位列***
 多元领域，覆盖处方药、健康药业产品、疫苗和动物保健品
 疫苗领域的领导者
 领先动物保健市场
 2011年集团净销售额达334亿欧元

赛诺菲在中国
赛诺菲是首批在中国开设办事处的跨国制药集团，也是国内增长最快的医药健康企业之一。目前，赛诺菲在中国200多个城市拥有6000余名员工。
   
传承悠久历史、持续开拓进取
赛诺菲一直以来秉承对中国的承诺。1982年，赛诺菲成为首批在中国开设办事处的跨国制药企业之一。今天，赛诺菲已跻身中国医药健康市场的领军企业。赛诺菲的中国总部位于上海，并在北京、天津、沈阳、济南、上海、杭州、南京、武汉、成都、广州和乌鲁木齐共设11家区域办公室。

独特的医药健康产品系列、满足中国公共卫生需求
从预防到治疗，赛诺菲全方位满足中国的公共健康需求。集团的疫苗事业部赛诺菲巴斯德是中国领先的疫苗企业。赛诺菲在心血管/血栓、糖尿病、肿瘤、内科和中枢神经系统等关键的治疗领域拥有领先产品。2010年，杭州赛诺菲民生健康药业有限公司的成立标志着赛诺菲进入中国的非处方药市场。2011年2月，赛诺菲完成了对BMP太阳石的收购。

大幅投资工业建设、满足中国市场需求
赛诺菲目前在中国拥有六家生产基地，包括北京制药工厂、杭州制药工厂、杭州赛诺菲民生健康药业工厂、南昌梅里亚动物保健工厂、深圳赛诺菲巴斯德疫苗工厂、以及唐山健康药业工厂。

完善的研发架构、双赢的研发合作模式
在中国，赛诺菲具有从药物靶点发现到后期临床研究的整体研发实力。集团在上海设有中国研发中心和亚太研发中心，并在北京和成都分别设有研发机构。自2008年以来，赛诺菲与中国权威科研机构开展了10多项战略合作，在癌症、干细胞、糖尿病和老年疾病等前沿研究领域探索创新药物

依托于强劲的研发能力和多领域领先水平的广泛的医药产品资源，公司在中国的市场份额不断攀升，公司规模不断扩大，飞速发展的业务给了我们与更多优秀人才合作的机会。

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