北京招聘

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.

Zai Lab is an innovative biopharmaceutical company based in Zhang Jiang, Shanghai focused on bringing transformative medicines for cancer, autoimmune and infectious diseases to patients in China and around the world. Zai Lab focus on innovation to meets the unmet medical needs. Zai has built up a strong pipeline with multiple programs on clinical stages. Zai Lab successfully listed on Nasdaq in Sep. 2017.

再鼎医药是一家总部设立于上海张江，致力于研究、开发和销售创新药物的制药企业。再鼎医药针对目前尚无良好治疗手段的疾病领域开发新药，在肿瘤、抗感染、自身免疫等方面建立了全面的产品线，服务中国和全球病患。再鼎医药于2017年9月在美国纳斯达克成功上市。