Career Category
ComplianceJob Description
Compliance Director
We are currently seeking a Director Compliance for China. The successful candidate will be responsible to manage a team of Compliance professionals (2) and will be a strategic 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.
Additional key activities include:
- Develop the Compliance teams via best practice sharing, leadership development initiatives and coaching, career planning, projects, etc.
- Sit on the Management Team and play a strategic role both from a compliance and business perspective
- Representing compliance on key business and cross-functional forums.
- Act as the interface for Compliance Leads in the region and Functional Leads.
- Provide leadership, advice, guidance, direction and support Compliance Leads and Functional Leads on interpretation and implementation of International and Country Codes and constantly changing Chinese legislation and Amgen healthcare compliance policies and procedures.
- Support Corporate Compliance Communication strategies and participate in the development of specific International communication strategies that will maximize awareness, trust and compliance with Amgen’s business practices, policies and procedures.
- Attend (as required) country business reviews to provide strategic input on related compliance matters
- Participate in the local country management teams as well WC&BE regional management and advisory teams as required.
- 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
- Validate affiliate/HQ site audit corrective actions in conjunction with Corporate Audit.
- Articulate a comprehensive risk management, implementing an effective remediation plan for existing and future risks
- Prevent key root issues for current and future activities
- Understand the intrinsic risk of data management in China with new Cyber security laws and regulations
- Be the Data Privacy officer for China, data management systems and articulate remediation plans in order to reduce gaps
Requirements:
- Bachelor/ Master’s degree in Law, Science or Business
- At least 8 years compliance-related experience (preferably in a Pharmaceutical, Life Sciences, Medical Device )
- Relevant experience in pharma/ biotech business is highly preferred - Understands the pharma/biotech business model, regulatory process & compliance guidelines.
- Expertise in providing sound, ethical advice to management on a broad range of business issues.
- Ability to act and strong understanding of relevant business processes within the industry, including but not limited to medical, market access, marketing and sales related aspects impacting the business processes.
- Ability to mediate and reconcile different views and to demonstrate leadership
- Empathic and passionate individual with the ability to build meaningful connections with stakeholders.
- Sensitivity to diverse groups of people both internal and external with the ability to manage many different opinions and perspectives.
- Ability to exercise good judgment in challenging or adverse situations, while remaining solutions oriented
- Ability to conduct detailed and accurate in-depth compliance analysis and provide related advice
- Ability to summarize, transform and communicate complex messages into pragmatic business language.
- Ability to collaborate in a matrix organization (from country to region to HQ teams)
- Outstanding verbal and written communications skills and an ability to adapt one’s approach to a challenge, as well as excellent interpersonal skills.
- Fluency in Chines and English, additional languages preferred
Amgen
We are one of the world’s leading biotechnology companies, with a particular focus on cardiovascular disease, oncology, bone health, neuroscience, nephrology and inflammation. And we put much of our success discovering and producing medicines and therapies down to our biology first approach.
In short, this is a place for innovation. Where ideas are not just welcome, but celebrated. Where you will have a peer group of 20,000 inspirational colleagues, not to mention the resources only a $20bn+ business can provide. This is your chance to make a positive impact on the world.
The benefits
Our holistic approach is one of the reasons why we are regularly recognized as a ‘Best Place To Work’ – you will find us focused on your wellbeing too.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Join Us
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.
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