Associate Scientist
上海康德保瑞医学临床研究有限公司
- 公司规模：150-500人
- 公司性质：合资(欧美)
- 公司行业：医疗/护理/卫生
职位信息
- 发布日期：2015-05-23
- 工作地点：上海
- 招聘人数：1
- 语言要求：英语熟练
- 职位月薪：面议
- 职位类别：医药技术研发管理人员
职位描述
Basic Major Activities (Describe main activities)
1. Prepare high quality CMC documents to support business needs in development.
2. Prepare high quality CMC documents to support TechOps and other division for global marketed products.
3. Support preparation of necessary submission documents in collaboration with RegCMC and DRA.
4. Meet quality, quantity and timelines in all assigned projects.
Education ：Degree in Science (e.g. Analytical Chemistry, Bioanalysis) or equivalent
Languages:Fluent English and Mandarin required (oral and written).
Experience/Professional requirement:
1. Working knowledge/experience in pharmaceutical devel-opment and regulatory submission document preparation.
2. Ability to work on multiple projects under pressure of time and workload.
3. Excellent written/spoken communication
4. Computer literacy.
1. Prepare high quality CMC documents to support business needs in development.
2. Prepare high quality CMC documents to support TechOps and other division for global marketed products.
3. Support preparation of necessary submission documents in collaboration with RegCMC and DRA.
4. Meet quality, quantity and timelines in all assigned projects.
Education ：Degree in Science (e.g. Analytical Chemistry, Bioanalysis) or equivalent
Languages:Fluent English and Mandarin required (oral and written).
Experience/Professional requirement:
1. Working knowledge/experience in pharmaceutical devel-opment and regulatory submission document preparation.
2. Ability to work on multiple projects under pressure of time and workload.
3. Excellent written/spoken communication
4. Computer literacy.
公司介绍
WuXi PRA Clinical Research (Shanghai) Co., Ltd. offers comprehensive Phase I-IV clinical trial services in Mainland China, Hong Kong and the Asia region. With 5 offices and staff based in 17 cities across China, WuXiPRA’s locally based project teams operate with the support of PRA’s global resources, clinical research expertise, global technologies and SOPs. This centralized operational approach promotes higher quality and outstanding client service. WuXiPRA has invested significantly in staff focused on CFDA regulatory expertise, project management and clinical informatics resources, as well as other support services, including RPS embedded strategic outsourcing.
上海康德保瑞医学临床研究有限公司在中国内地、香港及亚洲地区提供全方位的I-IV期临床试验服务。 康德保瑞在中国有5个办公室，员工分布在17个城市，其团队拥有保瑞医药丰富的全球资源和临床研究专业知识以及全球化的技术和标准操作规程支持。这些有助于全球性、区域性以及本土的临床试验运作达到更高的质量。康德保瑞在人员方面投入巨大，主要集中在CFDA注册专业知识、项目管理、临床信息资源以及包括战略外包服务的其它支持服务方面。
上海康德保瑞医学临床研究有限公司在中国内地、香港及亚洲地区提供全方位的I-IV期临床试验服务。 康德保瑞在中国有5个办公室，员工分布在17个城市，其团队拥有保瑞医药丰富的全球资源和临床研究专业知识以及全球化的技术和标准操作规程支持。这些有助于全球性、区域性以及本土的临床试验运作达到更高的质量。康德保瑞在人员方面投入巨大，主要集中在CFDA注册专业知识、项目管理、临床信息资源以及包括战略外包服务的其它支持服务方面。