临床/项目经理
捷斯瑞医药有限公司
- 公司规模:150-500人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2014-08-06
- 工作地点:北京
- 招聘人数:若干
- 工作经验:三年以上
- 学历要求:本科
- 语言要求:英语精通
- 职位类别:生物工程/生物制药
职位描述
Position Responsibilities:
1. Provide medical evaluation and support to BD staff on the new products.
2.Responsible for product complaints and safety issues, provide review, evaluation and assistance to customer service department.
3.Be responsible for medical review, including CTA/NDA files, PI/label, Publication/manuscript, etc, verifying the medical accuracy of all claims, and contribute to prepare documentation and submission on clinical trial summary.
4.Communicate with regulatory government / institutes and internal departments on product clinical trial issues.
5.Be a scientific leader in local registration clinical trials:
Prepare the medical section of documents for discussions/meetings with regulatory authorities
Effectively and clearly communicate with overseas partner for protocol writing. And be responsible for protocol discussion, amendments, review of the IB/PI/IC, CRF and statistical analysis plan
Supports investigator identification/site selection feasibility assessments, and initial medical discussions with investigators
Reviews statistical tables, identifies additional analyses, interprets clinical data, review final study CSR
6.Manage local Phase IV, post-marketing surveillance and review protocol of investigator initiated study
7.Make good relationship with experts and external KOLs management
Position Requirements:
1. Medical background with master/doctor degree
2. Well GCP trained
3. 3-5 years working experience in medical affairs/clinical operation/R&D field
4. Previous working experience in MNC pharmaceutical industry is preferred.
5. Medical-scientific writing skills
6. Fluency in English (oral and written) is essential
7. Good project management skill
8. Superior interpersonal and communication skill
9. Able to work under pressure in a busy environment
10. Responsible, professional, detail oriented and with patience
11. Flexible and works well in team
1. Provide medical evaluation and support to BD staff on the new products.
2.Responsible for product complaints and safety issues, provide review, evaluation and assistance to customer service department.
3.Be responsible for medical review, including CTA/NDA files, PI/label, Publication/manuscript, etc, verifying the medical accuracy of all claims, and contribute to prepare documentation and submission on clinical trial summary.
4.Communicate with regulatory government / institutes and internal departments on product clinical trial issues.
5.Be a scientific leader in local registration clinical trials:
Prepare the medical section of documents for discussions/meetings with regulatory authorities
Effectively and clearly communicate with overseas partner for protocol writing. And be responsible for protocol discussion, amendments, review of the IB/PI/IC, CRF and statistical analysis plan
Supports investigator identification/site selection feasibility assessments, and initial medical discussions with investigators
Reviews statistical tables, identifies additional analyses, interprets clinical data, review final study CSR
6.Manage local Phase IV, post-marketing surveillance and review protocol of investigator initiated study
7.Make good relationship with experts and external KOLs management
Position Requirements:
1. Medical background with master/doctor degree
2. Well GCP trained
3. 3-5 years working experience in medical affairs/clinical operation/R&D field
4. Previous working experience in MNC pharmaceutical industry is preferred.
5. Medical-scientific writing skills
6. Fluency in English (oral and written) is essential
7. Good project management skill
8. Superior interpersonal and communication skill
9. Able to work under pressure in a busy environment
10. Responsible, professional, detail oriented and with patience
11. Flexible and works well in team
公司介绍
捷斯瑞医药有限公司(www.gc-rise.com)是一家由欧洲知名的专注于健康产业的投资公司Inventages在华投资的外商独资企业。公司秉承“致力人类健康,创造美好生活”的使命,充分利用我们在美国、欧洲和日本战略合作伙伴的业务发展网络以及在中国丰富的临床开发、试验、注册的经验,雄厚的商业分销、医院销售和市场营销的实力,为中国广大的患者带来新型、安全、高效的医疗产品和治疗理念。
公司强调以人为本,重视人员的培养和发展。竭力为员工提供广阔的发展空间,实现公司与员工共同发展的最终目的。捷斯瑞将始终为各类人才打造一个施展才华的平台,并努力为求职者的职业生涯提供一个愉快、健康向上的工作环境。
满足公司价值观“以人为本,诚信正直,追求卓越,勇于负责,持之以恒,沟通团结,积极热情,变革创新,快速反应”的应聘者将是我们的首选对象。
应聘简历请发送至公司邮箱。
非常感谢您向我公司提交简历,对于合格的应聘者,我们会发送面试通知。更多详细情况请登陆:捷斯瑞医药有限公司网站http://www.gc-rise.com
公司强调以人为本,重视人员的培养和发展。竭力为员工提供广阔的发展空间,实现公司与员工共同发展的最终目的。捷斯瑞将始终为各类人才打造一个施展才华的平台,并努力为求职者的职业生涯提供一个愉快、健康向上的工作环境。
满足公司价值观“以人为本,诚信正直,追求卓越,勇于负责,持之以恒,沟通团结,积极热情,变革创新,快速反应”的应聘者将是我们的首选对象。
应聘简历请发送至公司邮箱。
非常感谢您向我公司提交简历,对于合格的应聘者,我们会发送面试通知。更多详细情况请登陆:捷斯瑞医药有限公司网站http://www.gc-rise.com
联系方式
- 公司网站:http://www.gc-rise.com
- 公司地址:北京朝阳区
- 邮政编码:100025
- 联系人:人力资源部