Medical Monitor
印度瑞迪博士实验室有限公司北京代表处
- 公司规模:50-150人
- 公司性质:外企代表处
- 公司行业:制药/生物工程
职位信息
- 发布日期:2022-06-28
- 工作地点:北京-朝阳区
- 工作经验:3-4年经验
- 学历要求:本科
- 职位月薪:5-7万
- 职位类别:临床研究员
职位描述
Role : Senior Scientist
Role Band : R2
Reporting To : Lead-Clinical Operations, GCM
Work Location: Beijing
Key Responsibilities:
- Medical monitoring and Sponsor oversight of assigned clinical trial/project(s) from both medical and scientific perspectives, to ensure protocol and regulatory guidelines are followed.
- Continuous Medical Monitoring of trials which includes eligibility assessment, general protocol queries, and safety and study investigational product related questions, review of lab reports, waiver requests, major protocol deviations/violations assessment and regular follow up of enrolled patients.
- Presentation on protocol and study conduct, wherever required
- Interaction with regulatory authorities in Chinese region
- Act as medical liaison between the investigators and the internal clinical operations team.
- Interact with investigators intermittently during study conduct to understand any recruitment and medical challenges in study protocols; and provide suggestions.
- Preparation and Review of study documents (Protocol, ICF, CRF and CSR) to ensure safety, regulatory and ethical compliance
- Resolution of medical and safety related queries from sites and project team
- Resolution of queries from the regulatory and/or the ethics committees.
- Oversee project team and CROs during SQVs and SIVs
- KOL interactions to validate concepts on new product introduction and unmet need in different therapy areas in Chinese region
- Project management of Patient based Clinical studies in Chinese region
Educational Qualification & Experience Required:
Registered Physician (Bachelor/Masters in Medicine) with 3 -6 years’ experience in Medical monitoring
职能类别:临床研究员
公司介绍
Dr. Reddy’s has been developing business in China for over 20 years and is known as the *** multinational imported generics pharmaceutical company in the country. In 2000, we set up Kunshan Rotam Reddy Pharmaceutical Co Ltd as a joint venture involved in manufacturing, sales and marketing. In 2010, we established Dr. Reddy’s Laboratories Ltd (Beijing) Representative Office in China to manage regulatory affairs and import drug filing. In 2020, we set up WOFE Dr. Reddy’s (Beijing) Pharmaceutical Co. Limited. and Dr. Reddy’s (Beijing) Pharmaceutical Co. Limited Shanghai Branch to enable commercial related activities in China, as part of our expansion plan.
In Dr. Reddy’s China, all Reddy’s people pull together, trust and respect each other and work hand in hand. As a global enterprise, we provides our employees with a professional working environment with high-standard and strict requirements which makes our work more professional and reliable. We keep growing, and creating more opportunities for the future development, we provides a plentiful external training opportunities, upgrading employees’ skills, let each employee grow together with us.
As a family care about global health, we are here to share our knowledge and product to bring good health to China and the world.
瑞迪博士(Dr. Reddy’s)成立于1984年,总部位于印度海德拉巴,拥有21,000多名员工,是全球第二大印度制药公司、全球仿制药公司***0之一。瑞迪博士的制药服务和原料药,全球仿制药,专利药和生物仿制药业务遍及全球80个国家。
瑞迪博士在中国已经发展20多年,是中国***大跨国进口仿制药制药公司。2000年,我们成立了集生产、销售和市场于一体的合资企业昆山龙灯瑞迪制药有限公司,2010年,我们在中国设立瑞迪博士实验室(北京)代表处,进行进口药品注册申报事务,2020年,我们成立外商独资企业瑞迪博士(北京)药业有限公司和瑞迪博士(北京)药业有限公司上海分公司,在中国开展产品商业相关活动,这是我们业务扩张计划的一部分。
在中国,瑞迪人依旧齐心协力,彼此信任,尊重彼此携手前行。作为一家全球化的企业,为员工提供高标准严要求的专业工作环境,让工作更为专业可靠。瑞迪公司通过不断壮大,给未来发展创造了更多机遇,我们也为员工提供丰富的外部培训机会,提升员工技能,让每位员工和我们一同成长。
加入瑞迪,我们一起聚梦瑞迪,共塑健康世界!
联系方式
- 公司地址:建国路91号金地中心A座