Amgen

Senior Counsel -- R&D Regulatory

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Aug 09, 2019
Ref
R-79105
Required Education
Bachelors Degree
Position Type
Full time
This Senior Counsel role will primarily be responsible for legal support of Amgen's Global Development organization, including Drug Delivery, Global Regulatory Affairs and Safety and other R&D functions. The successful attorney candidate will work directly with clients, providing strategic and practical legal counsel on a wide variety of drug and device development legal and regulatory issues. He/she will work independently and in teams as a strategic partner to identify and advise on business and regulatory issues with important legal implications. He/she will interact with internal clients and Law Department colleagues in different countries and across departments.

Basic Qualifications:

J.D. degree or LL.M. degree from an 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 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 Self-starter 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

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.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

At Amgen, contributions are recognized - and strong performance is rewarded. Regularly recognized as a "Best Place to Work," we enable staff to chart their own career paths based on their unique talents by offering challenging assignments, active career development, coaching and individual rewards.

Join Us

If 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.