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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 comprehensive support for all China clinical trial supply activities, encompassing but not limited to: addressing challenges in China clinical trial supply, forecasting and managing local packaging and labeling projects, overseeing local distribution activities and managing local IMP task force, reviewing IMP labels and maintaining the label review system, managing capacity and budget for local activities.
• Responsible for post market study drug supply including but not limited to: drug supply strategy coordination with IMP-Delivery, PMS, TA, controller, supply chain, channel and other stakeholders, development and organization of drug supply plans, management of the drug supply life cycle.
• Coordinate IMP-Delivery quality system qualification and implement the system.
• Serve as the quality contact for Medicine, including setting goals, tracking progress, and managing quality-related issues.
• Develop and uphold 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. Assist with GMP audits, both internal and external, as needed.
• Actively organize 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.
• Engage with IMP-Delivery for global trial supply management, global distribution, and IRT topics to build experience supporting both international and local operations.
• 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. This includes proactively fostering collaboration for the introduction and enhancement of IMP supply processes, ensuring mutual understanding, and building lasting trust among all parties involved.
• Develop team members into subject matter experts in their fields.

Job Requirements

• Master degree or above in science with more than 15 years of professional experience on drug development, quality or supply chain in pharmaceutical industry
• 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.