Syneos FSP Top Global Pharma Location: Shanghai Jing'an district/Beijing Chaoyang district Basic purpose of the job The major purpose of this position is to provide support to observational studiesin T.C.M., including: -Support the design, implementation and reporting of observational studies. -Participate in PMO plan development in T.C.M. from a real world data perspective. -Act as the primary contact person for quality, compliance, legal, purchase, finance and other related functions in T.C.M. Epi. Description Support the design and operation of non-interventional (NIS) and investigator initiated studies (IIS). Participate in PMO plan development and implementation in T.C.M. from observational study perspective. Work with colleagues to improve the network with key external experts for NIS and IIS in China. Review, assess, and summarize medical literature (in English and Chinese) to support study development, regulatory responses, and internal decision making. Profile Training in medicine, epidemiology, public health, outcomes research, health services research, economics, or a related field, with suggested alternatives as follows: Master’s degree (MS/MPH) in epidemiology, outcomes research, health services research, economics or a related field from an accredited institution. Relevant experience in the healthcare industry (Pharma/Biotech preferred) or academia is preferred, OR MD with non- degree training in epidemiology, public health, outcomes research, or economics. Relevant experience in the healthcare industry (Pharma/Biotech preferred) or academia is preferred. Required Capabilities (Skills, Experience, Competencies) Knowledge of, or experience with, Chinese big data sources, including health insurance data or electronic medical record data Knowledge in medicine, epidemiology or statistics Proficient ability to speak, read and write in English and Chinese Proactive, responsible, and accountable Able to work independently as well as in cross-functional groups Recommends improvements and alternative solutions to resolve problems Basic pharmacovigilance knowledge
