Senior Counsel - R&D Regulatory

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

BASIC 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

PREFERRED QUALIFICATIONS:

• 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 of biotechnology/pharmaceutical/device products (including federal and state anti-kickback and healthcare/fraud and abuse laws).
• 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 WILL DO

Let’s do this. Let’s change the world. In this vital role the Senior Counsel -R&D Regulatory will be responsible for legal support of Amgen’s Global Development organization, as well as Global Regulatory Affairs, Patient Safety, Medical Affairs, R&D Quality and Compliance, Precision Medicine, Drug Delivery, and other R&D functions.

RESPONSIBILITIES:

• Working directly with clients, provide strategic 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.
• Collaborate with internal clients and Law Department colleagues in different countries and across departments.