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
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