医学经理/总监

面议

上海市

刷新时间：2021-04-23

职位描述

1. Maintain scientific and clinical knowledge in the specific therapeutic and disease areas

2. Contribute to the clinical development strategy for the relevant therapeutic/disease areas
3. Conduct literature searches and analyze the data and information necessary to create the clinical development plan
4. Take medical responsibilities for clinical trials:
5. Develop clinical study design for internal reviews
6. Provide support to clinical operation and other groups to develop Informed Consent Form (ICF), Case Report Form (CRF), CRF instructions, etc
7. Review and/or write additional clinical science documentation and/or provide clinical science input into other documentation managed by other groups
8. Collaborate with data management and other groups to conduct medical review of study data, identify and evaluate the data outliers and query the sites
9. Collaborate clinical operation and other groups to identify and evaluate the protocol deviations
10. Review the study report and respond to authority’s inquiries
11. Prepare or review abstracts, posters, and content for scientific events etc.
12. Collaborate with regulatory and other team to complete and submit regulatory filings and other regulatory documentation.
13. Collaborate with PV to review safety data and provide medical support and judgement to ensure the high standards of clinical safety
14. Provide medical support to Commercial, Market Access, Regulatory, Pharmacovigilance, and Legal Counsel
15. Provide initial and ongoing medical trainings to MSLs and commercial team and in collaboration with MSL to provide training to external staff
16. Review training documents and other promotional or non-promotional materials to ensure medical accuracy and compliance with regulatory requirements



Qualifications:

1. Masters Degree at least in life sciences required. The experience in oncology, hematology or with a broad medical background is preferred

2. Minimal 3 years in clinical practice, pharmaceutical medical affairs or clinical development
3. Able to work within matrix organization and provide leadership
4. Design and implement clinical trials
5. Disease area knowledge, including key scientific publications
6. Well-versed in medical aspects of GCP, ICH, CFDA
7. Good scientific thinking, agility in learning and good communication skills
8. Good computer skills (Word, PowerPoint and Excel skills)

其他要求

招聘人数：1人
职能类别：医学经理/主管

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业，总部位于杭州，下属有上海、南京、广州、武汉等多家分公司，同时自主开发国内领先的猎头办公系统及医药人才网站，全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台，在欧、美、日等国家建立了海归引进平台，同时积极开展医药高等院校公益系列讲座，搭建了以人力、企业为主体的立体化咨询服务网，为医药企业人才队伍建设发挥了积极重要作用，为很多医药企业解决了高端人力之困。