北京招聘

Job Description:

I. PK/BE/CT strategy

？ Draft the PK/BE/CT strategy based on Clinical use and the requirements by CFDA regulatory.

？ Identify and confirm RLD and testing samples available, and procure RLD in China or import it by one-time IDL.

？ Collaborate with India team for CRO and Hospital Site auditing.

II. CRO and Site identification and protocol finalization

？ Identification of CRO’s for conducting the PK/BE/CT in china.

？ Coordinate with different CROs/Hospital /Bioanalytical sites to facilitate the protocol finalization process.

？ Collaborate with India team for shipment of Investigational products for conducting PK/BE/CT at CRO/Hospital Site.

？ Project management of biostudies: e.g. Support in providing documents like EC submissions, OHGRA approval, Import license, e.t.c.

III. PK/BE/CT following up

？ Onsite monitoring of PK/BE/CT at Hospital sites.

？ Follow up and get updates for the ongoing PK/BE/CT at CRO’s.

？ Collaborate and work closely with different stake holders in India and China RO office for seamless execution of Biostudies.

？ Facilitate Study closeout activities at CRO/Hospital sites.

IV. Finalization of PK/BE/CT report for filing

？ Facilitate finalization of pivotal PK/BE/CT -reports as per Chinese regulations and assist submission for regulatory filing.

V. Assist and company CFDA auditing to Hospital Site

？ Schedule, assist and company CFDA auditing Hospital Site based on CFDA timeline.

？ To provide support in addressing bio-deficiencies received from CFDA.

Dr. Reddy’s, founded in 1984 and headquartered in Hyderabad, India. The company owns 21,000+ employees and is the second largest Indian pharmaceutical company in the world and one of the ***0 global generics companies. Dr. Reddy’s business spans Pharmaceutical Services & Active Ingredients (PSAI), Global Generics, Proprietary Products and Biosimilars, in 80 countries across the world.
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！