天津招聘

Responsibilities

1.Identify and develop clinical research strategies in China for Ferring products in specialty area

2.Develop the content writing of clinical research related documents including clinical trial protocol, Investigator's Brochure, clinical study report etc. to support clinical trial research and meet local registration needs

3.Contribute to the preparation of the dossier and providing answers to the CDE (Center of Drug Evaluation) in a timely fashion during any stages of clinical trial proceeding

4.Support approval of clinical and strategic initiatives from IPCs and/or local regulatory authorities

5.Ensure ICH-GCP, local regulatory and global policy compliance

6.Ongoing review and develop SOPs as well as standard documentation tool kits applicable to clinical operations in China

Requirments:

1.Ph.D. degree in pharmaceutical/clinical sciences or related disciplines with the major in Gynecology or Maternity

2.Either at least 2 years of international pharmaceutical industry experience in clinical study planning, execution, reporting and publishing activities or at least 4 years of clinical experience in Gynaecology/obstetrics or Gastroenterology

3.Good understanding of the overall drug development process, clinical trial methodology, China regulatory environment, ICH/GCP Guidelines and International regulations

4.Fluent in both English and Chinese.

5.Good communication and interpersonal skills - works well with others, motivates and encourages

6.Proficiency in Basic Microsoft Word, Outlook, PowerPoint and Excel