苏州招聘

Department: Clinical Quality Assurance

SUMMARY OF RELEVANT JOB RESPONSIBILITIES

· Support for SOP lifecycle in Electronic Documents Management System (EDMS).

· Provide system training and technical support to C&R and Discovery functions.

· Prepare SOP/CD report and share to C&R and Discovery functions regularly.

· Maintain C&R and Discovery training matrix.

· Monitor and report training compliance.

MAJOR RESPONSIBILITIES AND DUTIES

SOP/CD life cycle management

· Takes process owner role for SOP on SOP, be responsible for regularly review of the SOP and ensure it is compliant with regulation requirements.

· Takes Document Controller role for EDMS system, co-ordinates C&R and Discovery SOP/CDs workflow in EDMS.

· Be expert of EDMS and ELMS (Electronic Learning Management System), deliver system training to end user and provide technical support to end users.

· Ensures the archiving of policies, SOPs and processes documents.

Training

· Maintains role based training curriculum for all function lines within C&R and Discovery.

· Ensures role-based trainings be timely and correctly assigned to the specific job roles through training system, inactive account for those who left the HM.

· Ensures training courses be created and distributed in the training system timely and properly.

· Tracks training compliance status regularly and report non-compliance to management team.

· Develops, deliveries and facilitates regulation, GCP/GVP, HMP SOP and system related trainings when necessary.

· Ensures paper training records are archived properly.

POSITION QUALIFICATIONS & REQUIREMENTS

· Minimum bachelor’s degree in clinical medicine or Life/Biological Sciences, advanced degree preferred.

· 3-5 years’ clinical research experience in pharmaceutical, or CRO company.

· Experience in SOP development, review and approval preferred.

· Experience in Documents Management System and Training System preferred.

· QA experience or relevant experience in clinical quality management preferred.

· Project management experience with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities a plus.

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。