上海招聘

Responsible for ensuring the completeness, accuracy, timeliness, quality and integrity of the Clinical
Trial Medical Coding tasks. Ensure data quality and consistency per applicable regulatory
requirements, SOP(s), Processes and data standards. Works with the project team to meet the study
objectives.

MAJOR RESPONSIBILITIES AND DUTIES

？ Ensure all data management activities to be compliance with GCP, relevant regulatory requirements
and SOP/WI (work instructions) of Hutch-Med.
？ Ensure following and applying CDISC or applicable standard through Clinical Trail.
？ Follow and keep compliance with Hutch-Med SOPs, work instructions to be knowledgeable in
applicable sections as bellows, but limited to:
？ A. Create and Maintain Dictionary Coding Conventions;
？ B. Setup and perform dictionary coding in clinical trials;
？ C. Perform independent QC of coding process;
？ D. Managing Medical Dictionaries at function level;
？ Ensure acknowledge, follow and to be consistent with Hutch-Med Policies and procedures.
？ Update technical skills and knowledge for continuous enhancement of work.

QUALIFICATIONS:

Specialized Knowledge
？ Working experience of clinical development process, understanding CFDA/FDA requirements of
clinical trials.
？ Knowledge of clinical trial database and its applications.
？ Knowledge of Medical coding dictionary such as MedDRA and WhoDrug or other coding dictionary.
？ Knowledge of GCP and regulatory requirements of clinical trials.
Minimum Requirements:
？ Educated to at least Bachelor level in Medicine, Pharmacy, Biological Sciences, or health care
related disciplines.
？ For coder, at least 3 years’ experience working in medical coding
？ For Sr Coder, at least 5+ years’ experience working on clinical trial medical coding and its
application.
Preferred Requirements:
？ Previous experience within a data management role will be preferred.
？ Work with project teams to identify and articulate complex problems.
？ Effective interpersonal skills and collaborative team player.
？ Communicate effectively and appropriately with internal & external team.
？ Effective plan and organize work for delivery within timeline, and able to prioritize to manage multitasks.

和黄中国医药科技有限公司（简称“ 和黄医药 ”或“ Chi-Med ”）（纳斯达克 / 伦交所：HCM）是一家创新型生物医药公司，在过去20年间致力于发现和全球开发治疗癌症和自身免疫性疾病的靶向药物和免疫疗法。目前，和黄医药共有8个抗癌类候选药物正在全球开发中，并在中国本土市场拥有广泛的商业网络。

和黄医药成立于2002年，为在纽约和伦敦两地上市的和黄中国医药科技有限公司（纳斯达克/伦交所： HCM）旗下专注于新药研发业务的子公司, 研发中心坐落在上海浦东张江高科技园区，海外临床开发及注册中心位于美国新泽西，具有完备的研发平台和GMP生产基地。管理团队成员均有在知名跨国医药和生物医药企业工作的经历，参与了多个全球新药研发；公司目前有500余位来自海内外，拥有丰富新药研发经验的科研人员，8大临床在研药物、 30多项临床试验在全球开展。

和黄医药是一家致力于创新药物研发的生物医药公司，专注于发现和开发治疗癌症和自身免疫性疾病的靶向药物和免疫疗法。 自主研发的抗肿瘤新药呋喹替尼已于2018年9月获国家药品监督管理局批准上市，并于2019年11月获纳入国家医保药品目录。公司的其他候选药物，如索凡替尼、沃利替尼等，也已进入后期开发，有望在2020及2021年上市。