天津相关职位： 云检医学-质谱实验员 医药代表 投标专员 业务专员（医疗设备，需有驾照） 销售经理/项目经理（天津） 药械科主任/维修 中药验收员 分析研究员 X射线荧光光谱化学分析师 董事长高级助理（战略发展）
周边城市招聘： 上海 浙江 安徽 广东 山东 河北 重庆 北京 江苏 湖南
企业入驻日期： 2017-11-09
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10年以上经验 -
博士 -
招若干人 -
11-09 发布
职位描述
职位描述： 岗位职责:Job Description:1.Responsible for the management and implantation of the clinical product development and regulatory strategy, including, either by direct generation or through professional service providers, but not limited to2.Oversee the clinical direction, medical planning, execution and medical interpretation of clinical trials3.Establish and approve scientific methods for design and implementation of clinical protocols, data collection systems and final reports4.Develop strategic clinical relationships with physicians, vendors, business contacts, external experts and/or relevant scientific organizations, either directly or through clinical operations5.May recruit clinical investigators and oversee or negotiate study budgets and contracts6.Coordinate and develop information and documents for regulatory authorities7.Coordinate and develop information and presentations for senior management, clinical collaborators and/or other groups8.Contribute to preparation of a variety of corporate and regulatory clinical documents9.Attend high-level national and international medical meetings10.Participate in communication (i.e. publication, abstracts)11.Ensure each project to be conducted according the state of the art quality systems (e.g. internal quality management system, GCP ICH, etc). The latter may include generation, maintenance and management of relevant standard operating procedures 任职资格:Job Requirements:1.Doctor of Medicine is required2.At least 10 years of experience in clinical development and regulatory affairs in the pharmaceutical/biotech industry3.Knowledgeable and experienced in interpretation of regulations and guidelines related to drug development 4.Capable of strategic thinking and proposing innovative solutions to regulatory problems5.Hands-on experience in clinical study design and conduct, Experience with original IND, BLA or NDA in eCTD formatted submissions6.Good working knowledge of Mircosoft Office. Experience in GCP ICH is required7.Fluent written and spoken English, Chinese and French language would be preferred8.Demonstrate excellent teamwork and communication skills with ability to impact and influence the decisions of a team9.Flexible, mature, self-motivated, independent and able to work under pressure. Organized, rapid and with special attention to details. Open-minded, working well in a team as well as with external contacts (i.e. external consultants and professional service providers, regulatory agency personnel). Have good communication and presentation skills, Willingness to travelLocation: Tianjin 职能类别： 生物工程/生物制药 医药技术研发管理人员
联系方式
北辰区普济河东道2号 天士力现代中药城
公司信息
天士力医药集团股份有限公司创建于1994年，公司成立以来，始终秉承“创造健康，人人共享”的企业愿景，推动中医药与现代医学融合发展，以提高人类生活和生命质量为使命，致力于打造中药现代化、国际化***，以成为全球现代中药创新的领导者、现代中药科学标准的制定者为目标，实现现代中药为核心，协同生物药和化学药为两翼的国际化产业格局。 公司业务涵盖医药领域的科研、种植、提取、制剂、营销全产业链，为国家认定的高新技术企业。公司产品以现代中药为核心，协同生物药和化学药为两翼的发展新模式，构建了现代生物医药产业集群。
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