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Senior Counsel - R&D Regulatory

Employer
Amgen
Location
Washington D.C., District of Columbia
Start date
May 18, 2024

View more

Discipline
Regulatory, Legal/Compliance, Regulatory Affairs
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Best Places to Work

Job Details

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.

Senior Counsel - R&D Regulatory

Live

What you will do

Lets do this. Lets change the world. In this vital role the Senior Counsel -R&D Regulatory will be responsible for legal support of Amgens 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.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Senior Counsel we seek possesses these qualifications.

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.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

  • Stock-based long-term incentives

  • Award-winning time-off plans and bi-annual company-wide shutdowns

  • Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

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 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 accommodation.

#obesity

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
US

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