研发负责人

通过Ben

研发负责人

  • 北京

一家知名的,专业的医疗器械公司

岗位职责:

Job responsibilities:

 

1、负责公司新药研发项目的项目协调及项目进度管理,包括实验室内部和委托CRO/CDMO进行的各项临床前研究的沟通和协调工作;

Be responsible for the project new product management for the new products, including the communication and coordination of various preclinical studies within the laboratory and entrusted cro / cdmo;

 

2、预测及制定每个关键阶段的里程碑,并分阶段跟踪项目进展情况,把控项目实施的质量和速度;

Predict and formulate the milestones of each key stage for the project, track the progress of the project by stages, and control the quality and speed of project implementation;

 

3、协调公司内部资源,协调解决项目实施过程中出现的瓶颈问题,确保项目按照计划顺利推进;

Coordinate the internal resources of the company, and solve the bottleneck problems in the process of project implementation, and ensure the smooth progress of the project according to the plan;

 

4、组织跨部门沟通协调,确保项目管理的有效执行;

Organize cross departmental communication and coordination to ensure the effective implementation of projects;

 

5、负责新药研发项目对外委托事宜,包括合同洽谈、项目开展和监督跟进,确保项目进度和质量。

Be responsible for the external entrustment of new drug R & D projects, including contract negotiation, project development, supervision and follow-up, so as to ensure the progress and quality of the project.

 

6、协调研发、注册、市场等多部门进行沟通协作;

Coordinate R & D, registration, marketing and other departments to communicate and cooperate;

 

7、负责建立与完善部门内部各项目管理相关管理制度、流程及标准;

Be responsible for establishing and improving management systems, processes and standards related to project management within the Departments;

 

8、为项目成员提供技术和管理能力的指导及培训;

Provide guidance and training on technical and management ability for project members;

 

9、定期向上级领导(研发副总裁)汇报所有项目的进度、费用、成本、质量等信息,识别各项目风险点并监督改进措施的落实情况;

Regularly report the progress, cost, quality and other information of all projects to the superior leaders (vice president of R & D), identify the risk points of each project and supervise the implementation of improvement measures;

 

10、项目档案的管理:协助收集和整理凭证类文件、项目阶段总结报告等技术文件,按要求完成各类文件的归档、登记、借阅等项目档案的管理工作.

Management of project archives: assist in the collection and sorting of certificate documents, project stage summary reports and other technical documents, and complete the management of project archives such as archiving, registration and borrowing of various documents as required

 

任职要求:

Job requirements:

 

1、药理、药学、毒理、生物医药、药学或管理等相关专业,本科及以上学历;

Bachelor degree or above in pharmacology, pharmacy, toxicology, biomedicine, pharmacy or management;

 

2、熟悉新药开发和注册全过程,熟悉中国以及EMA/FDA相关法规;

Be familiar with the whole process of new drug development and registration, and be familiar with relevant regulations of China and EMA / FDA;

 

3、具有3年以上药物研发或者新药项目管理经验,有相关项目管理资质认定证书优先;

At least 3 years of experience in drug R & D or new drug project management, and relevant qualification or certificate is preferred;

 

4、具有良好的执行力、沟通协调能力、学习能力、适应能力及计划组织能力。

Good executive ability, communication and coordination ability, learning ability, adaptability and planning and organization ability.

 

5、优良的英语阅读和口语表达能力;

Good at English both on reading and oral

 

要申请此工作 请将您的详细情况发送到以下邮箱 welcome@crseek.com

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Ben