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, the company will launch new medicines or indications in therapeutic areas including CV & metabolism, respiratory, oncology, immunology, CNS and retinal health to meet the demand of Chinese patients.
Job Responsibilities -Work with local Medicine project teams and TAs in supporting China CTA and NDA submissions, including relevant document preparation, review, and proofreading, as well as HA interactions -Work with global DMPK function and project teams for necessary information in supporting China CTA and NDA submissions and in ensuring China requirements -Act as lead within DMPK Working Groups, coordinating the regular group meetings, projects progress update, DMPK related HGRAC submission process optimization etc. -Provide technology support on PK (e.g., LC-MS and Biologics assay testing, ADA and Nab) method evaluation, draft of HGRAC submission rationale, method transfer and troubleshooting, as well as relevant activities, as needed -Explore the connections to Chinese academia, CROs, and consortia on topics such as DMPK innovations, new technologies, potential collaborations -Participate in and support other relevant and increasing activities within Development and China Medicine.
Qualifications -MS degree in science with more than 6 years of professional experience on bioanalysis in pharmaceutical industry, or Ph.D. degree with 3+ years -Experiences with immunogenicity is preferred -Excellent knowledge of international regulatory guidelines, especially GLP and GCP for human pharmaceuticals -Fluent in both Chinese and English -Entrepreneurial thinking and can-do attitude -Strong interpersonal & communication skills; demonstrated ability to work effectively in a team environment -Excellent ability to communicate effectively both orally and in writing in an interdisciplinary environment. -Willingness to travel on as needed (Germany, US, China)
