Healthcare Compliance Director
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.
Healthcare Compliance DirectorLive
What you will do
Lets do this. Lets change the world. In this vital role you will will have a leadership role within Amgens Worldwide Compliance and Business Ethics department (WC&BE). WC&BE is a highly strategic function at Amgen and consists of specially qualified and highly-motivated professionals who work closely with Amgens various U.S. business units to identify and advise on compliance risks and strategies. In this position, the Compliance Director will be responsible for providing strategic advice and direction to the General Manager/VP of one or more of the following business units in the U.S.: Bone Health, Cardiology, Inflammation, Nephrology, Neurology, Oncology or Value & Access. This position may also provide compliance support for other functions such as U.S. Medical and Global Government Affairs. This individual may also serve as the compliance lead for business development activities. Most importantly, this individual will serve as the face of WC&BE to assigned areas of the business and will work objectively to provide strategic guidance on compliance issues or concerns within those areas.Key Responsibilities:
Advising business leadership in U.S. Commercial Operations, Medical, and Government Affairs functions
Working with other teams, including: Policy, Training, Communications, Healthcare Compliance Operations, Corporate Audit, Monitoring, Investigations, Global Risk Assessment, Global Privacy Office, Trade Compliance, Outside the U.S. (OUS) Regional Compliance
Cross-functional partnering with: Legal, Regulatory Promotions, Human Resources, FinanceKey activities of this individual will include:
- Providing strategic guidance on compliance issues and situations
- Handling day-to-day compliance related questions and issues
- Ensuring policies and standards are understood and followed
- Providing training and reports on a regular basis to senior management regarding the operation and progress of compliance efforts
- Ensuring alignment and proper communication and training around systems and guidance
- Supporting audit, investigations and monitoring activities
- Chairing and facilitating functional compliance forums with business leaders to review compliance matters, risks, and trends and to identify mitigation actions
- Identifying potential areas of compliance vulnerability and risk
- Serving as the channel of communication for compliance related issues
- 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 20% (post pandemic)
- May serve as the compliance lead for business development activities
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Healthcare Compliance Director we seek thrives in a high-performing and collaborative environment, and has these qualifications.Basic Qualifications:
Doctorate degree and 4 years of Compliance, Legal, Audit, Monitoring, or Regulatory experienceOr
Masters degree and 7 years of Compliance, Legal, Audit, Monitoring, or Regulatory experienceOr
Bachelors degree and 9 years of Compliance, Legal, Audit, Monitoring, or Regulatory experiencePreferred Qualifications:
- 5 years of Pharmaceutical/Biotech industry experience, particularly in Compliance, Legal, Audit, Monitoring, Regulatory Affairs, or cross-functional experience in Sales, Marketing, or Medical
- Knowledge and understanding of Office of Inspector General (OIG) Compliance Program Guidance for Pharmaceutical Manufacturers, Pharmaceutical Research and Manufacturers of America (PhRMA) Code, U.S. Federal Anti-Kickback Statute, current Corporate Integrity Agreements (CIAs), Accreditation Council for Continuing Medical Education (ACCME) guidelines, Prescription Drug Marketing Act, FDA commercial guidelines, U.S. data privacy laws and regulations, U.S. Federal and State transparency reporting requirements, and other relevant laws and regulations
- Understanding of sales, marketing, product promotion, disease education, device regulatory, clinical research, and healthcare compliance
- Direct experience counseling and influencing internal clients and cross functional partners
- Ability to handle ambiguity and sophisticated situations
- Strong ability to synthesize and analyze vast amounts of complex data, and clearly and concisely articulate relevant points and conclusions at the right altitude depending on the purpose and the audience
- Demonstrated ability to think creatively and strategically, translate strategy into action plans, and effectively drive issues to closure
- Ability to handle, prioritize and follow through on a high volume of work
- Demonstrated ability to be a self-starter, and to participate in a highly collaborative, team-oriented environment
- Ability to work with all levels of management and staff and build relationships across subject areas
- Excellent communication and presentation skills
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
careers.amgen.comEqual Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Join UsIf 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.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.