Associate Manager, IMP Delivery China
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
- Provide support for all China clinical trial supply activities with minimum support from supervisor, including addressing challenges in China clinical trial supply, reviewing IMP labels and maintaining the label review system, packaging and labeling activities. Support the global team in forecasting, allocation and management of the local packaging and labeling projects. Manage the trial of China alone trials. Coordinate the capacity and budget for local activities.
- Implement activities in post market study drug supply with minimum support from supervisor including but not limited to: Drug supply strategy implementation with IMP-Delivery, Post Marketing Study, TA, controller, supply chain, channel and other stakeholders. Development and organization of drug supply plans. Management of the drug supply life cycle.
- Support IMP-Delivery quality system qualification and implement the system in collaboration with stakeholders.
- Follow the local standard operating procedures (SOPs) for applicable activities.
- Engage in consistent communication about the clinical trial process, assess local requirements, and effectively relay China’s regulatory standards to global teams.
- Assist in site inspections conducted by local and international authorities regarding Investigational Medicinal Product (IMP) inquiries.
- Actively support and participate in the industrial activities, such as RDPAC Clinical Trial Supply Forum, group meetings, and site engagement activities to gather industrial intelligence and support ecosystem development.
- Support to develop, maintain, and strengthen connections with the IMP-Delivery team as well as other global and local stakeholders to effectively support China clinical trial supply-related activities.
- Support Development CMC China activities as need. Attend all the required meetings and input the actions as required.
Job Requirements
- Bachelor degree in science with more than 8 years of professional experience on drug development, quality or supply chain in pharmaceutical industry, or MS degree with 6+ years
- Excellent project management, interpersonal & communication skills
- Fluent in both Chinese and English
- Excellent knowledge of international regulatory guidelines and quality standards, especially GMP for human pharmaceuticals
- Entrepreneurial thinking and attitude
- Willingness to think outside the box
- Willing to undertake business travel on a reasonable basis
- Experience in clinical trial supply, especially in distribution will be a superior.