Amgen Compliance Director - Bone and Cardiology Business Unit in Thousand Oaks, California

Amgen's Worldwide Compliance and Business Ethics department (WC&BE) consists of a highly qualified and motivated team of professionals who identify, review, evaluate, manage and advise on compliance considerations within the organization. In this position, the incumbent will be responsible for providing strategic advice and direction to the General Manager/VP of the Bone and Cardiology Business Unit. This position will oversee the Compliance Program at a functional level. Most importantly, this individual will serve as the 'face' of WC&BE to the business and will work objectively to provide strategic guidance on compliance issues or concerns within the function.

Key Responsibilities:

  • Advising business leadership in Global Commercial Operations and Corporate Affairs, in particular, for portions of the US Business

  • Working with other WC&BE teams, including:

  • Policy, Training, Communication & Anti-Corruption

  • Healthcare Compliance Operations

  • Audit & Monitoring

  • Investigations

  • Regional Compliance

  • Cross-functional partnering with:

  • Regulatory Promotions

  • Legal

  • Human Resources

  • Key activities of this individual will include:

  • Managing day-to-day compliance related questions and issues

  • Ensuring policies and standards are understood and followed

  • Ensuring alignment and proper communication and training around systems and guidance

  • Identifying potential areas of compliance vulnerability and risk

  • Providing strategic guidance on compliance issues and situations

  • Be the channel of communication for compliance related issues

  • Providing training and reports on a regular basis to senior management regarding the operation and progress of compliance efforts

  • Remaining abreast of external compliance activities

  • Implementing compliance engagement, or where appropriate, corrective action plans

  • Special projects and other duties as assigned

Domestic travel up to 25%

Basic Qualifications

  • Doctorate degree and 4 years of regulatory and/or legal and/or compliance experience

OR

  • Master's degree and 7 years of regulatory and/or legal and/or compliance experience

OR

  • Bachelor's degree and 9 years of regulatory and/or legal and/or compliance experience

Preferred Qualifications

  • Knowledge of related laws and regulations

  • Understanding of sales, marketing, product promotion, disease education, device regulatory, clinical research and healthcare compliance

  • Pharmaceutical/Biotech industry experience, particularly in Compliance, Legal, Regulatory Affairs, or cross-functional experience in Sales or Marketing, Medical

  • Direct responsibility for counseling and influencing internal clients and cross functional stakeholders

  • Ability to handle ambiguity and complex situations

  • Strong ability to synthesize vast amounts of complex data, and clearly and concisely articulate the relevant points at the right altitude

  • Ability to think strategically and to translate strategy into action plans

  • Ability to prioritize, be proactive, resolve conflicts, meet deadlines, and be a team player

  • Ability to work with all levels of management and build relationships across disciplines

  • Excellent communication and presentation skills

Amgen is committed to unlocking the potential for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

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.

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.