Regulatory Submissions Coordinator
北京MEDPACE医药科技有限公司
- 公司行业:制药/生物工程
职位信息
- 发布日期:2020-09-29
- 工作地点:北京
- 招聘人数:1人
- 工作经验:3-4年经验
- 学历要求:本科
- 职位月薪:1.4-1.8万/月
- 职位类别:政府事务管理 临床协调员
职位描述
Responsibilities
- Perform required activities within the country that lead to activation of investigative sites in all phases of clinical trials;
- Prepare, review, and submit to Ethics Committees and Regulatory Agencies;
- Provide expertise and guidance to global study teams in ethics and regulatory submissions;
- Review and finalize essential documents required for site activation;
- Act as a main contact for Ethical and Regulatory submission-related activities;
- Direct contact with investigative sites during the study start up and activation process; and
- Track submissions and ensure timely filing of documents.
Qualifications
- Bachelor's degree;
- At least two years of relevant working experience at a CRO, Pharmaceutical Company, or an investigative site;
- Knowledge of Microsoft® Office;
- Knowledge of ICH - GCP guidelines and regulatory guidelines; and
- Fluency in English.
Kindly submit an English version of your resume.
Please note that actual job title will be in line with candidate experience.
公司介绍
北京MEDOACE医药科技有限公司是一家美资独资在全球排名前十的CRO 公司,主要为欧美及亚太地区的新药上市提供临床监察,注册,数据统计及实验室服务。公司总部设立在美国俄亥俄州的辛辛那提,全球有超过4500名员工分布在28个国家。
联系方式
- Email:y.wang@medpace.com