Amgen manufactures and markets biopharmaceutical products that are subject to oversight and regulation by several entities of the U.S. Federal government. The attorney in this position will be responsible for counseling Amgen's commercial operations on a wide variety of legal and regulatory issues concerning contracting, sales and promotion of biopharmaceutical products in the United States.
The primary responsibilities of this position will include:
Advising and counseling on complex commercial transactions with members of the healthcare community (managed care organizations, hospitals, Group Purchasing Organizations (GPO) and distributors), with particular emphasis on the Anti-Kickback Statute and applicable antitrust laws
Reviewing of government enforcement actions relating to the promotion of biopharmaceutical products
Providing on-going training to commercial operations staff regarding legal and regulatory requirements for commercial activity in the biopharmaceutical industry
The responsibilities of this position may also include:
Analyzing, reviewing and approving promotional materials
Providing guidance on proposed sales and marketing strategies.
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 corporate and/or law firm experience providing counsel on, and structuring, complex corporate or commercial contracts
Experience counseling clients on complex legal and regulatory considerations including:
Healthcare fraud and abuse matters
FDA promotional regulations
OIG compliance guidance and advisory opinions
DOJ settlements with pharmaceutical industry
Medicare/Medicaid reimbursement and contracting
Congressional hearings and inquiries
Proven superior legal skills, including: excellent oral and written communication, legal analysis and negotiation skills
Ability to lead and influence others
Strong client service focus
Ability to manage multi-dimensional projects in a fast-paced environment
Superior academic achievement
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.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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.
A little about us:
Amgen values the leadership, skills and passion for serving that veterans exemplify and our constant commitment to hiring the best starts here.