Medical Research Head

面议

上海市

刷新时间：2022-08-01

职位描述

Primary Function 主要职能：

The Head of Medical Office provides safety and quality oversight throughout the lifecycle of the company products (investigational and marketed). Maintain an overview of the safety profile in relation to medicinal products and the oversees the pharmacovigilance system within Ensure the Quality Management System is implemented in R&D functions and the regulatory activities are conducted in a compliance manner.

医学办公室负责人负责整体监管公司产品从临床到上市后整个生命周期的安全和质量。维护药品的安全性档案，全面监管公司内部的药物警戒系统。确保公司研发活动符合质量管理系统和有关法规的规定。

Major Responsibilities and Duties 主要职责和任务

1. Acts as Chairman of the Medical Safety Council which is the highest medical safety governance body engaged in setting standard for protecting the Medical Safety of patients and users of products, and provides strategic direction in product vigilance and patient/use safety at the enterprise level.

担任医学委员会主席，该委员会是公司最高级别的医学安全管理机构，致力于制定标准来保护产品的患者和使用者的医疗安全，并在企业层面为产品警戒和患者/使用者安全提供战略性指导。

2. Effectively interface cross-functionally at all levels in the organization, Contract Research Organizations (CROs) as well as with external Regulatory Authorities.

须要与公司内各职能部门，CRO 和监管机构有效的接触与沟通。

3. Leads all major pre- and post-marketing safety deliverables including signal detection, benefit-risk evaluation and risk management activities.

领导所有主要的上市前及上市后安全工作包括安全信号检测，获益-风险评价及风险管理活动。

4. Provide oversight on the preparation and review of safety-related section(s) for clinical, regulatory, and scientific documents including protocols, informed consent/assent forms, case report forms (CRFs), statistical plans, clinical study reports/synopses, integrated summaries of safety, New Drug or Biologic License Applications (NDA/BLA), Marketing Authorization Applications (MAA), Common Technical briefing books, manuscripts/journal articles and other documents as needed, ensuring safety profile reflected for assigned products.

总体监督临床，注册及科学文件中安全相关章节的准备和审阅包括研究方案，知情同意书/评估表，病例报告表，统计计划，临床研究报告/概要，安全汇总，新药/生物制品上市申请，市场许可申请，CTD 递交，监管机构问询回复，IRB/EC 回复，综述资料，待发表文献等，以确保产品安全性得到正确的反应。

5. Interacts with cross functions regarding drug development programs, study design and protocol. Reviews and provides input for protocol development. Interacts with key thought leaders and/or sponsor representatives to develop inclusion/exclusion criteria and study endpoints. Interacts in team approach to develop statistical and data management sections of the protocol. Reviews the final protocol for clinical, safety and efficacy variables.

关于药物开发项目，试验与方案设计进行跨部门合作。审阅临床研究方案并提供意见。与关键意见领袖和/或申办方代表沟通，旨在确定入排标准及试验终点。与团队沟通来确定方案中统计及数据管理段落。审阅终版方案中的临床，安全性和有效性的变量。

6. Oversees the implementation of R&D Quality Management System to ensure the country specific health authority laws and regulations and international practices are complied with.

监督研发质量管理体系的实施，确保各国适用的卫生部门的法律法规和国际惯例都得到遵守。

7. Provide strategic direction for establishing and maintaining a quality-oriented organization that assures sustainable compliance with the laws and regulations governing drug discovery and development.

致力于对建立、维护质量导向的R&D 组织提供战略方向，确保符合药物发现及开发相关法规以及计算机系统符合相关监管标准。

Qualifications 资格要求:

1. Minimum 10 years of biopharmaceutical industry experience in drug development and Pharmacovigilance/Quality.

至少10 年生物药物行业药物开发及药物警戒/质量领域工作经验

2. Licensed M.D. ideal

执业医师。

3. Demonstrate good leadership, strategic thinking and long-term vision.

具有良好的领导力，战略思维和长远规划能力。

4. Ability to work in partnership with a multidisciplinary group of colleagues, including translating concepts into practical approaches and promoting consensus. Promote teamwork.

能够与各不同领域的同事合作，包括将概念落实于实践并且倡导达成一致。提倡团队合作。

5. Ability to organize and work efficiently on several projects, each with specific requirements and/or shifting priorities。

可以在多个不同要求及重点的项目中合理组织并高效工作。

6. Excellent oral and written communications skills as well as interpersonal skills are essential

卓越的口头和书面沟通能力于人际交往能力。

7. Ability to travel domestically and internationally as required.

可以接受国内外出差。

其他要求

招聘人数：10人
职能类别：医学总监

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业，总部位于杭州，下属有上海、南京、广州、武汉等多家分公司，同时自主开发国内领先的猎头办公系统及医药人才网站，全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台，在欧、美、日等国家建立了海归引进平台，同时积极开展医药高等院校公益系列讲座，搭建了以人力、企业为主体的立体化咨询服务网，为医药企业人才队伍建设发挥了积极重要作用，为很多医药企业解决了高端人力之困。