南京招聘

职位描述：

A career at Merck is an ongoing journey of discovery: our 50,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

Job Description:

Provides statistical, clinical data management and programming for the medical department. Collaborates in the production of the study protocols, provides and/or facilitates sample size calculations. Reviews case report forms (CRFs) to ensure appropriate data collection, cleaning, statistical analysis and reporting of the study. Enhances understanding of statistical hypothesis testing and presentations

• Guide and lead local office/region in CQM principles, regulated requirements, audit preparation and resolution of follow up (CAPA management).


• Contribute to Global CQM initiatives & documentation and ensure global practices are followed appropriately in local environments.


• Revision and maintenance of Quality Documents for GCO. Provide functional process expertise for stakeholders within and outside of GCO


• Evaluate and drive continuous process improvements. Ensure quality and compliance in the organization to both internal and external Inspection standards


• Evaluate audit and inspection findings across studies. Coordinate CAPA development for GCO-process related topics and manage implementation and maintenance of a CAPA tracking and reporting tool for GCO.


• Implement Quality Management in outsourced studies. Contribute to development of Quality section(s) in CRO manual(s). Contribute to define risk-based vendor oversight


• Implement key quality management processes and quality by design principles into GCO


• Implement risk management, identify significant and systematic quality risks, develop mitigation strategies


• Oversight of local archiving activities, working with teams and also Global CQM Archiving leads on local and global needs.


• Proactively identify and propose training needs for GCO in regards to new or revised Quality Documents


• Contribute to updates to GCO Senior Management on GCO-related quality matters

Job Requirements:

• Advanced degree in Life Sciences (e.g. biology, chemistry, pharmaceuticals) or equivalent


• Minimum 6 years of experience in clinical development in pharmaceutical industry or CRO or equivalent, at least three years direct involvement in sponsor – CRO interaction for global trials


• Quality Management or QA experience


• Experience in different functions in the clinical development area


• Experience as leader of cross-functional teams


• HR 85527

What we offer: At Merck, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at come2merck.com

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