This Counsel will be responsible for counseling Amgen's Global Commercial Operations clients on a wide variety of legal and regulatory issues concerning promotion, sales, patient support programs, contracting, education and scientific exchange regarding biopharmaceutical products in the United States.
The primary responsibilities of this position will include:
Analyzing, reviewing and approving promotional, educational and support programs and materials
Analyzing, reviewing and approving scientific exchange and clinical support approaches
Providing guidance on proposed sales and marketing strategies
Reviewing and counseling on 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
Advising and counseling on complex commercial transactions with members of the healthcare community (hospitals, clinics, payors, specialty pharmacy, pharmacy benefit managers, patient and professional advocacy groups/associations) with particular emphasis on Federal and State Anti-Kickback and False Claims Statutes and applicable antitrust laws
J.D. degree or LL.M. degree from an accredited law school
Admission to practice law in a U.S. jurisdiction
Two (2) years of experience practicing law
4+ years of corporate and/or law firm experience counseling clients on healthcare/life sciences matters
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
Proven superior legal skills, including: excellent oral and written communication, legal analysis, drafting and negotiation skills
Ability to lead and influence others
Strong client service, business counseling and problem-solving 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.
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, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.
Amgen's outstanding compensation package features comprehensive benefits. To learn more about this opportunity and to apply, please visit us online at http://careers.amgen.com/ and search job #R-83018.
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.