This drug and combination product Counsel will provide strategic and practical advice to the global operations, global quality, global regulatory affairs and safety client groups on a variety of business and regulatory issues with important legal and product development implications. The successful candidate will independently, and on teams, interact with these clients and Law Department colleagues in different countries and across departments.
- Working with the FDA and the laws and regulations relating to the discovery, development, and approval of delivery devices and combination products that are comprised of a medical device and drug or biologic
- Addressing GMP/QSR aspects of FDA and international health authorities laws and regulations.
- Providing real-time counseling and legal advice to clients for Good Manufacturing Practice related matters, including non-conformances (NCs), Biologic Product Deviations (BPDs), and Corrective and Preventive Action Plans (CAPAs) across multiple manufacturing operations.
- Partnering with Global Operations, Quality and Manufacturing organizations to identify areas for continuing improvement and to develop compliance strategies.
- Providing legal review of documents to be submitted to global health regulatory authorities, as appropriate.
- Helping ensure consistency of legal advice through close collaboration with other Law Department colleagues
- Developing and delivering legal training materials.
- Advising business functions regarding FDA regulations, policies and procedures relating to all phases of medical device development and commercialization, in particular those related to drug delivery devices
- Advising business functions regarding quality system regulations, medical device reporting (MDRs), complaint handling and device and combination drug product advertising and promotion
J.D. degree or LL.M. degree from an accredited law school, admission to practice law in a U.S. jurisdiction and two (2) years of experience practicing law
- 4+ years at a law firm, biopharmaceutical company law department, device company law department, major government agency or a combination of these
- Experience working with the laws, regulations, policies and procedures of the FDA, and of international health authorities, relating to manufacturing operations and post-market surveillance (e.g. complaints) of medical device, drug, biologic or combination products
- A thorough understanding of quality system regulation and regulatory reporting requirements (BPDRs, FARs, MDRs)
- Experience with the development and commercialization of in vitro diagnostics (IVDs)
- Excellent interpersonal skills
- Ability to handle, prioritize and follow through on diverse issues on a timely basis
- Excellent writing and verbal skills
- Resourceful and able to participate in highly collaborative, cross-functional team-oriented environment
- Experience managing multi-dimensional projects in fast paced environment and the ability to meet demanding deadlines; self-starter
- Able to understand complex matters, to identify meaningful regulatory/legal issues, and to effectively provide advice
- Excellent interpersonal communication skills to interact with clients and Law Department colleagues in different countries and across departments.
- Able to understand complex matters and critically analyze them to provide advice to clients.
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 uses its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds 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!
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 meaningful assignments, active career development, mentoring and individual rewards.
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.