Senior Counsel - R&D Regulatory
HOW MIGHT YOU DEFY IMAGINATION?
If you feel likeyourepart 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 achievetogetherresearching,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.
Senior Counsel - R&D Regulatory
What you will do
Lets do this. Lets change the world. In this vital role you will be responsible forlegal support of Amgens Global Development organization, as well as Global Regulatory Affairs, Patient Safety, Medical Affairs, GCP Compliance, Drug Delivery, and other R&D functions.
Workingdirectly withclients, providestrategic and practical legal counsel on a wide variety of drug and device development legal and regulatory issues.
As a strategic partner, work to identify and advise on business and regulatory issues with important legal implications both independently and as part of a larger team.
Collaboratewith internal clients and Law Department colleagues in different countries and across departments.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. TheSr Counselprofessional we seek is has these qualifications:
J.D. degree or LL.M. degree from an ABA accredited law school, admission to practice law in a U.S. jurisdiction and four (4) years of experience practicing law
6+ years of experience as an attorney in a large law firm, biopharmaceutical company, or in a major government agency practicing law related to biotechnology, pharmaceutical, device and/or healthcare.
Experience working with the FDA and the laws and regulations relating to the discovery, development, approval, sales & marketing ofbiotechnology/pharmaceutical/deviceproducts (including the federal and state anti-kickback laws and healthcare/fraud and abuse issues).
Experience with clinical and consultant contracts, and/or products liability.
Excellent interpersonal skills.
Ability to handle, prioritize and follow through on diverse issues on a timely basis.
Resourceful and able to participate in highly collaborative, cross-functional team-oriented environment.
Ability to meet demanding deadlines.
Strong research and writing skills.
Manage multi-dimensional projects in fast paced environment.
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.
Equal 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.