1) Collaborate with medical directors to develop clinical study synopsis, study protocols, IB, DSUR and other clinical and regulatory documents that are required for clinical projects project teams and regulatory staff to develop key submission documents in the regulatory dossier including Clinical Overviews, Briefing documents for regulatory authorities and Advisory Committees, as well as other documents for clinical trials and regulatory submissions

2) In collaboration with medical directors and regulatory team to author clinical study protocols, clinical study reports (CSRs) and other regulatory documents for submissions including IB, IND, NDA/BLA, sNDA/sBLA, preIND meeting requests, preIND meeting preparation materials, and other relevant documents.

职位要求：

1) Teamwork experiences and strong interpersonal skills in promoting teamwork and to ensure effective team communication.

2) Strong background in life science.

3) Preferred at least 2 years or more working experiences in pharmaceutical industry.

4) Excellent oral and written communication skills and experiences in developing processes and standards to ensure the quality and compliance of clinical regulatory documents.

5) Experiences working with medical writing vendors/CROs is a plus.

6) Knowledge of drug development, ICH/GCP regulations, regulatory guidelines and reviewers’ expectations is a plus.

上班地址：上海浦东张江高科技园区金科路4560号金创大厦1号楼4楼