Medical Compliance Manager/医学合规经理

中国, 北京, Beijing

en de fr es ru tr it pt ja

You will be responsible for:

  • Reviewing corresponding event applications to make sure compliance with Dia Symphony and related SOP’s, Good Clinical Practice (GCP) and HCP guidelines; Review HCP PPTs and Roche promotion materials to ensure no off-label promotion.
  • Conducting clinical quality control activities, according to the relevant NMPA and global regulations, guidance, standards and RDSL SOPs.
  • Assisting clinical operation function, provide direction and optimization of local process according to the requests of Divisional Standard, GCP and QC observation.
  • Leading training needs analysis, plan development, supervise the implementation of training of local clinical operation function. Provide training of clinical trial quality related topics as needed.
  • Developing and adopting the IT systems and tools to facilitate and standardize the local clinical operation process, together with the supports of local IT and global counterparts.
  • Developing and maintaining a good working relationship with BAs and other dept. to support the cross-functional projects.
  • Developing career and development plan for subordinates.
  • Conducting Other projects or tasks assigned by line manager.
  • Conducting business in full compliance including but not limited to Roche Secure, Roche Behavior in Business, Roche Competition Law Interactive Dialogues, Roche Safety, Security Health and Environmental Protection.
  • Understand and fulfill the responsibility of line manager's SHE tasks and duties (as defined in SHE handbook).

You should have:

  • Bachelor Degree in Appropriate discipline
  • At least Bachelor degree in medical science degree, preferably in clinical medicine, medical laboratory, pharmacy administration, pharmacology, and biology
  • Proficiency in both spoken and written English
  • Good command of MS office software application
  • Understand pharmaceutical and/or medical device regulation
  • At least 8 years of working experience in clinical medicine, pharmaceutical, Medical Device, or in-vitro Diagnostics industry, and 3 years of working experience in medical compliance, clinical trial quality management
  • At least 5 years of project management or people leader experience are preferred
  • Highly effective oral and written communication skills; the ability to get ideas across one-on-in, in group settings as well as in presentation