Director, Compliance China

4 weeks ago

Shanghai, Shanghai, China Amgen Full time

Director, Compliance for Amgen 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 Head of Compliance Director for Amgen China, reporting directly to the regional compliance lead. The successful candidate will be a strategic and proactive compliance adviser to the business on all key initiatives. Reporting to this role will be two Compliance Managers, whom together will be responsible for the operationalization of an effective healthcare compliance and privacy program in alignment with Amgen global standards and practices and the seven elements of an effective compliance program.

Key Responsibilities:

  • In this capacity, the Compliance Director will:
  • 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.
  • Represent compliance on key business and cross-functional forums; provide leadership, advice, guidance, direction, and support to China Functional Leads on implementation of compliance-related guardrails relating to Chinese legislation, International and Country Codes, as well as Amgen healthcare compliance policies and procedures.
  • Serve as the Data Privacy officer for China, including the building up of a compliance system to meet requirements of China's Personal Information Protection Law (PIPL) and other applicable laws and regulations. Advise on Privacy and Data protection issues, including drafting privacy notices, templates and consents and ensuring consistency in practices and forms to be aligned with global/regional better practices.
  • Maintain awareness of applicable laws and regulations in China and keep current with changes that may affect Amgen China's compliance program.
  • Participate in Healthcare Compliance & Privacy expert review of controlled documents, templates, and training; act as lead compliance subject matter expert.
  • Lead the development and delivery efforts of compliance and Privacy-related trainings, as required.
  • Support local Healthcare Compliance audit and monitoring activities and advise on appropriate remediation action steps.
  • Support Corporate Compliance Communication strategies and participate in the development of specific local communication strategies that will maximize awareness, trust, and compliance with Amgen's business practices, policies, and procedures.
  • Support investigations (led by global investigations) and provide local guidance in support of disciplinary or corrective actions (including root cause analysis), as appropriate.
  • Articulate a comprehensive risk management strategy, implementing an effective remediation plan for current and future risks.
  • Effectively partner with Amgen global compliance teams in developing and introducing global programmatic enhancements.
  • Attend (as required) country business reviews to provide strategic input on related compliance matters.

Basic Qualifications:

  • At least 15 years of working experiences including 7 years of compliance management role working experiences (preferably in a Pharmaceutical, Life Sciences, Medical Device).
  • Ability to effectively operate, communicate, and lead local compliance efforts in a matrix organization (from country to region to global teams)
  • Expertise in providing sound, ethical advice to management on a broad range of business issues.
  • Ability to conduct detailed and accurate in-depth compliance analysis and provide related advice.
  • Ability to mediate and reconcile different views and to demonstrate leadership, all whist maintaining compliance independence.
  • Empathic and passionate individual with the ability to build meaningful connections with stakeholders and team members across the organization.
  • Ability to exercise good judgment in challenging or adverse situations, while remaining solutions oriented.
  • Ability to summarize, transform and communicate complex messages into pragmatic business language.
  • 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 independently act with strong understanding of relevant business processes within the industry, including but not limited to medical, market access, marketing and sales related aspects impacting business processes
  • Keen business sense, ability to think strategically, and desire to establish a trusted business relationship with internal and external parties.

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.


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