At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.
Sr. Manager, Medical Compliance
YOUR TASKS AND RESPONSIBILITIES
• Perform as LSRP (Local SOP Responsible Person) and support medical functions on local SOP identification, development, training implementation and management. Work closely with global team to apply global standard.
• Be an expert on 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.
• Be an Expert on medical compliance regulations and quality system e.g. QDoc, Baylearn cross functionally.
• Design the Medical Compliance training plan at beginning of the year. Implement Medical Compliance training per plan.
• Involve in event sponsorship contract review and approval process, to ensure event sponsorship compliant with Global and Local quality standard and identify the Process improvement opportunity.
• 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.
• Work closely with medical functions before and during audit. Complete audit response independently.
• Collaborates with Marketing, Legal, Medical Advisor, Controlling, Pharmacovigilance, Global medical affairs operation and coordination to ensure local business needs and timelines are met.
WHO YOU ARE
• Education: Bachelor's degree or above in Medical/ Pharmaceutics
• Experience: 7+ years' experiences in related health field including 2+ years' experiences in Quality check / assurance and training experience is preferred.
• Good written, verbal skills, and presentation skills in both Chinese and English.
• Expertise in drug development, GCP and local regulations.
• Good analytical and communication skills with a clear understanding of both the customer and the marketplace.
• Ability to instruct and lead even senior people in key situation to get agreement on quality topics.
• Ability to identify opportunities and work with internal customers.
• Ability to develop work relationships internally with different groups.
• Good leadership capability.
• Focus on objective analysis and judgment working style.
• Work independently and undertake responsibility.
• Principle orientation.
• Good communication skill.
• Continuous self-learning willingness and ability.
Are you looking for a new challenge where you can show your passion for innovation? Are you interested in working as part of a global team to improve people’s lives? Then send us your online application including cover letter, CV and references.
Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Reference Code: 488527
Functional Area: 医学事务&药物警戒