Alliance Management Senior Specialist (CTS)
About Human Pharmaceutical Business
With global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of the patients we serve in the following key areas of interest: cardiovascular, respiratory, metabolic diseases, immunology, oncology and central nervous system. In the future, we will accelerate the launch of more than 10 innovative medicines to meet the demand of Chinese patients.
Job Responsibilities
-Support line manager on IMP-D (Investigational Medicinal Product Delivery) related activities including but not limited to packaging and labeling, IMP importation, label review, distribution support etc..
-Maintain regular contact with BI IMP-D and local teams to support China clinical trial supply activities. Focus on introducing or refining processes for IMP supply, while building mutual trust.
-Regularly communicate about the clinical trial process, understand local needs, and convey China's regulatory requirements to the global teams.
-Actively support quality system implementation and update, e.g. update and compliance of QAA, and quality activities, e.g. audit and inspection processes by local and international authorities. Support line manager with IMP-D quality system qualifications for both internal and external vendors, and share responsibility for strategic vendor management.
-Regular contact with BI IMP-D team and local teams to support China clinical trial supply related activities, for the introduction of new process or refine the process for IMP supply, building up mutual trust.
-Support other relevant activities within Development China.
Job Requirements
-Bachelor degree in science with more than 5 years of professional experience on clinical supply in pharmaceutical industry, or MS degree with 3+ years
-Excellent project management, interpersonal & communication skills
-Fluent in both Chinese and English
-Understand international regulatory guidelines and quality standards, especially GxP for human pharmaceuticals
-Entrepreneurial thinking and attitude
-Willingness to think outside the box
-Willing to undertake business travel on a reasonable basis
-Able to express complex scientific principles in both English and Chinese via presentation in internal and external meetings would be an advantage.