GED China Outsourcing Manager
默克雪兰诺有限公司
- 公司规模：5000-10000人
- 公司性质：外资(欧美)
- 公司行业：制药/生物工程
职位信息
- 发布日期：2017-04-10
- 工作地点：北京
- 招聘人数：1人
- 学历要求：硕士
- 语言要求：英语 熟练
- 职位月薪：2-2.5万/月
- 职位类别：生物工程/生物制药 医药技术研发管理人员
职位描述
职位描述：
KEY ACCOUNTABILITIES
？ Lead clinical pharmacology outsourcing to support China projects
o Maintains a robust and effective relationship with preferred partner CROs in given projects and manages any issues to an effective resolution.
o Ensure development and delivery of clinical bioanalytical strategy.
o Be responsible for quality aspects by supporting in- and external audit/inspection.
？ Contribute scientific excellence to China projects
o Represent GED/Clinical Pharmacology in China Program/Project Teams.
o Contribute to clinical protocol design, operation planning/sampling logistics.
o Participate in clinical report and regulatory dossier preparation/review.
？ Involve in China and pan-Asian R&D strategic discussion
o Seek opportunity for innovative early development pathways.
o Bring integrated thinking and planning cross disciplines with other China R&D line functions.
o Engage in joint China-Japan strategic planning.
EDUCATION
？ PhD or Master’s degree in pharmaceutical, biological or related field with 3-5+ years of post-graduate
？ experience in the life sciences industry.
？ Excellent verbal and written communication skills in English.
WORK EXPERIENCE
？ Experience working with a CRO or external partner.
？ Good understanding of drug discovery and development process, preferably with working experience in GLP and/or GCP.
？ Prior project management, project coordination, and/or contract and budget management experience.
？ General understanding of pharmacokinetics, pharmacodynamics, and biomarkers.
？ Familiar with regulations and guidelines from regional health authorities (e.g. CFDA).
？ Experience working in global setting with multi-cultural awareness.
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KEY ACCOUNTABILITIES
？ Lead clinical pharmacology outsourcing to support China projects
o Maintains a robust and effective relationship with preferred partner CROs in given projects and manages any issues to an effective resolution.
o Ensure development and delivery of clinical bioanalytical strategy.
o Be responsible for quality aspects by supporting in- and external audit/inspection.
？ Contribute scientific excellence to China projects
o Represent GED/Clinical Pharmacology in China Program/Project Teams.
o Contribute to clinical protocol design, operation planning/sampling logistics.
o Participate in clinical report and regulatory dossier preparation/review.
？ Involve in China and pan-Asian R&D strategic discussion
o Seek opportunity for innovative early development pathways.
o Bring integrated thinking and planning cross disciplines with other China R&D line functions.
o Engage in joint China-Japan strategic planning.
EDUCATION
？ PhD or Master’s degree in pharmaceutical, biological or related field with 3-5+ years of post-graduate
？ experience in the life sciences industry.
？ Excellent verbal and written communication skills in English.
WORK EXPERIENCE
？ Experience working with a CRO or external partner.
？ Good understanding of drug discovery and development process, preferably with working experience in GLP and/or GCP.
？ Prior project management, project coordination, and/or contract and budget management experience.
？ General understanding of pharmacokinetics, pharmacodynamics, and biomarkers.
？ Familiar with regulations and guidelines from regional health authorities (e.g. CFDA).
？ Experience working in global setting with multi-cultural awareness.
职能类别： 生物工程/生物制药 医药技术研发管理人员
关键字： clinical pharmacology biomarker CRO CFDA vendor GLP GCP project
公司介绍
默克雪兰诺有限公司
默克雪兰诺是总部位于德国达姆施塔特的全球医药和化工集团默克公司旗下生物制药业务分支。默克雪兰诺总部设在瑞士日内瓦，致力于发现、开发、生产和销售针对特定适应症的化学和生物的处方药。北美业务在美国和加拿大以EMD 雪兰诺的名称运营。
默克雪兰诺中国总部位于北京，拥有员工约1200人，业务遍及全国。目前，默克雪兰诺在中国经营9个领域18种药品，在未来几年里，还将上市多种新药。
默克雪兰诺是总部位于德国达姆施塔特的全球医药和化工集团默克公司旗下生物制药业务分支。默克雪兰诺总部设在瑞士日内瓦，致力于发现、开发、生产和销售针对特定适应症的化学和生物的处方药。北美业务在美国和加拿大以EMD 雪兰诺的名称运营。
默克雪兰诺中国总部位于北京，拥有员工约1200人，业务遍及全国。目前，默克雪兰诺在中国经营9个领域18种药品，在未来几年里，还将上市多种新药。
联系方式
- 公司地址：北京市朝阳区