清远招聘

  

PRIMARY FUNCTION

  

• Quality and Compliance Management in clinical product development.

  MAJOR RESPONSIBILITIES, AND DUTIES

• Implement and deliver the agreed upon Quality Control plan which includes risk management.

• Assist Clinical Operations to deliver a better compliance with relevant ICH, GCP, country regulations and guidelines.

• Contribute to the development of and responsible for implementation and delivery of specific initiatives as defined and agreed upon.

• Provide advice and support to Clinical Operations, Medical Science including Project Managers and other key stakeholders with regard to quality control, risk assessment and management, and corrective actions.

• QC activities including selected MVR review, TMF review and co-monitoring activities.

• Support QA activities.

  Qualifications

• At least bachelor degree in a health care or other scientific discipline. Clinical Medicine or pharmacy is preferred.

• At least 3 years industry experience with proven proficiency in clinical research management for drug development.

• Monitoring experience or equivalent combination of education, training and experience.

• Sound knowledge of medical terminology, clinical monitoring procedures (SOPs), GCP, CFDA regulation and quality.

• Knowledge of CRO or Pharmaceutical industry operations.

• Good organizational, interpersonal and communication skills.

• Good judgement and decision-making skills.

• Strong influencing and negotiation skills and excellent problem solving skills

• Demonstrated ability to work in a matrix environment

• Proficiency in English (written and oral) and familiarity with standard IT office tools.

  Internal-External Relations

  Internal: staffs in C&R department

  External: Investigators and other relevant persons in hospitals or institutes, business partner, CRO and other vendors

                                                      

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。