北京招聘

OSITION DETAILS

Medical Manager (level will be based on work experience)
Reports to: Associate Medical Director
Department: Clinical Pharmacology, Oncology
Location: Shanghai

KEY RESPONSIBILITIES

? Responsible for providing medical training and scientific support for assigned projects.
? Responsible for the organization and training of the medical team members.
? Responsible for the internal audit and quality control of the corresponding projects.

JOB REQUIREMENTS

1. To carry out the relevant medical support work for the project team, including the review and amendment of clinical research protocol, IB, Pharmacy Manual, ICF, CRF, SAE report, etc.
2. To maintain updated knowledge about clinical activities and studies conducted within the therapeutic area
3. To instruct the medical team members to complete the medical writing listed above and to be responsible to ensure the final quality of the work
4. To register studies to ClinicalTrials.gov, including updates and results
5. Responsible for the initiation of clinical trials for the corresponding project
6. Responsible for the internal audit and quality assurance of the clinical trials of the projects under its jurisdiction
7. To respond to scientific queries of investigators for the corresponding project
8. Have all the duties as medical manager, including dealing with urgent issues in a timely manner
9. Draft and maintain SOPs, as needed
10. Responsible for professional training and assessment of medical team members, evaluation and management of staff performance appraisal
11. Cooperate with other departments for clinical research and consultation



COMPETENCY REQUIREMENTS

? Ability to quality-manage clinical trials
? Has good leadership and execution skills
? Good command of English; fluent in writing, speaking and listening
? Ability to work independently, but at the same time has a good sense of teamwork
? Ability to problem-solve and risk-manage
? Ability to adapt under pressure
? Has strong interpersonal skills
? Good work ethics and dedication

SKILL REQUIREMENTS

? Solid knowledge of the overall drug development process and execution skills
? Familiar with ICH-GCP guidance, familiar with the whole process of drug research and development, and proficient in the clinical trial process
? Comprehensive knowledge of clinical trial management, and able to perform training and quality control
? Can independently access relevant literature
? Skills in conference presentations for both training and researcher
? Basic knowledge of computer skills and Office software applications

DESIRABLE BACKGROUND

? Education requirement: Master’s degree or above
? Professional requirements: Medicine, pharmacology, or pharmaceutical with clinical working experiences preferred
? Work experience: At least 5 years of work experience with at least 2 years in clinical trial management

江苏恒瑞医药股份有限公司始建于1970年，2000年在上海证券交易所上市，股票代码600276，是国内***的抗肿瘤药和 手术用药的研究和生产基地，国内最具创新能力的大型制药企业之一。 恒瑞医药在连云港、上海、成都、苏州、南京、美国、日本、澳大利亚等地均设有研发中心和分支机 构，目前各类研发人员1800多人，其中有1000多博士、硕士、及海归人士，有5人被列为国家“***”，7人被列入“江苏省高层次创新人才引进计划”，公司 雇员超过17000人。
上海盛迪医药有限公司是江苏恒瑞医药股份有限公司的全资子公司，公司位于上海浦东张江高科技园区，注册成本2.5亿元，占地面积14000平方米。上海盛迪作为恒瑞新药研发的重要组成部分，下设临床医学、中央医学事务、中央市场、临床前开发、新药协调、商务发展、转化医学、对外研发合作等核心职能。