Amgen China Compliance Lead in Shanghai, China
China Compliance Lead – China
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Job Summary :
We are currently seeking a Compliance Lead for China, who directly reports to China Head of Law and Compliance . The successful candidate will be responsible to manage a team of two Compliance professionals and will be a strong compliance adviser to all key initiatives. Additionally, this role will also promote and support adherence to all Healthcare Compliance and Privacy requirements (internal and external) for HQ activities.
In this capacity, the Compliance Sr. Manager will:
Develop the Compliance teams via best practice sharing, leadership development initiatives and coaching, career planning, projects, etc.
Support China Functional Leads on interpretation and implementation of International and Country Codes and constantly changing Chinese legislation and Amgen healthcare compliance policies and procedures.
Maintain awareness of applicable laws and regulations in China and keep current with changes that may affect Amgen’s compliance program.
Support the implementation of Corporate & Compliance Programs in China
Participate in Healthcare Compliance expert review of controlled documents, templates and training and if necessary, act as subject matter expert. Support/conduct roll out of controlled documents, templates & trainings (as required).
Deliver compliance training as required.
Support local Healthcare Compliance monitoring activities and follow up on improvement actions (if applicable).
Participate in and support the Compliance audit preparation: set up meetings with each department, prepare documentation requests and follow up on audit outcomes (if applicable).
Support for Investigations and create remediation actions in case of gaps / issues are detected
Be responsible for building up a compliance system to meet requirements from China Personal Information Protection law and other applicable laws and regulations. Be advising on Privacy and Data protection issues, including drafting privacy notices, templates and consents and ensuring consistency in practices and forms to be aligned with region.
Be collaborating with Audit, DTI and WC&BE functions regarding Privacy and Data Protection requirements to ensure compliance and programmatic improvement.
Basic Qualifications :
At least 15 years of working experiences including 5 years of compliance management role working experiences (preferably in a Pharmaceutical, Life Sciences, Medical Device).
Experience in managing people.
Strong working knowledge and experience with privacy and data protection laws (e.g. PIPL, China Cybersecurity Law and China Information Security Law).
Excellence written/verbal communication skills, and presentation skills in Mandarin and English.
Demonstrated ability to build and maintain solid relationships/connections across the organization.
Ability to work independently as well as collaboratively with enthusiasm and accountability
Keen business sense, ability to think strategically, results oriented and desire to establish a trusted business relationship with internal and external parties.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.