Medical Compliance Manager
Your tasks and responsibilities
1. Promote Bayer global quality system to all relevant functions, especially through all staffs in Medical Department of China. Meanwhile, promote Bayer quality management concept to external customers including investigators performing Bayer clinical trials through in collaboration with other functions.
2. Lead local procedure of medical compliance on identification, development, announcement, training implementation and management. Be the owner of the local procedure development process which applicable for entire Medical Department or cross functions. Work closely with global team to apply global standard.
3. Be a consultant on medical compliance regulations and quality system e.g. QDoc, Baylearn crossfunctionally.
4. Design the Medical Compliance training plan at beginning of the year. Implement Medical Compliance training per plan.
5. Involve in event sponsorship contract review and approval process, to ensure event sponsorship compliant with Global and Local quality standard.
6. Design and perform regular quality check according to the QC plan for all functions within Medical Department or cross function as needs. Together with functions heads to determine the action plan for findings resolving and ensure follow up action have been implemented.
7. Work closely with medical functions before and during audit. Complete audit response independently.
Who you are
1. Education: Bachelor's degree or above in Medical/ Pharmaceutics
2. Experience: 7+ years' experiences in related health field including 5+ years' experiences in medical department of pharmaceutical company. Quality check / assurance and training experience is preferred.
3. Good written, verbal skills, and presentation skills in both Chinese and English.
4. Expertise in drug development, GCP and local regulations.
5. Good analytical and communication skills with a clear understanding of both the customer and the marketplace.
6. Ability to instruct and lead even senior people in key situation to get agreement on quality topics.
7. Ability to identify opportunities and work with internal customers.
8. Ability to develop work relationships internally with different groups.
Expertise and skill requirement:
1. Good leadership capability.
2. Focus on objective analysis and judgment working style.
3. Work independently and undertake responsibility.
4. Principle orientation.
5. Good communication skill.
6. Continuous self-learning willingness and ability.