北京 [切换城市] 北京招聘北京生物/制药/医疗器械招聘北京临床协调员招聘

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