上海招聘Medical Manager/Director医学经理/总监

Medical Manager/Director医学经理/总监

复星凯特生物科技有限公司

公司规模：150-500人
公司性质：合资
公司行业：制药/生物工程

职位信息

发布日期：2021-06-03
工作地点：上海-浦东新区
招聘人数：1人
工作经验：5-7年经验
学历要求：硕士
职位月薪：2-4万/月
职位类别：生物工程/生物制药

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)

职能类别：生物工程/生物制药

公司介绍

关于复星凯特生物科技有限公司
复星凯特生物科技有限公司为上海复星医药集团与美国 Kite Pharma（吉利德旗下公司）的合营企业， 2017年 4月于中国上海注册成立。立足于自主研发和技术转移相结合，复星凯特致力于肿瘤免疫细胞治疗技的产业化和规范化，造福中国患者。

About Fosun Kite Biotechnology Co., Ltd.
As a joint venture of Shanghai Fosun Pharmaceutical (Group) Co., Ltd and U.S. Kite Pharma, Fosun Kite Biotechnology Co., Ltd. (hereinafter referred as "Fosun Kite") was established in April 2017 in Shanghai China. Taking a combined approach of internal R&D and external partnering/technology transfer, Fosun Kite is dedicated to the advancement of innovative cell therapy and its industrialization in China to benefit patients.

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