Locations: USA - Pennsylvania - Upper Providence, USA - Maryland - Rockville, USA - Massachusetts - Waltham, USA - North Carolina - Research Triangle Park, USA - Pennsylvania - Philadelphia.
This Senior Counsel, US Legal Ops – Oncology & Specialty opportunity is critical to support the growing US Oncology and Specialty Business Units by providing expert legal counsel on a range of activities covering the promotion, distribution, support, and sale of specialty medicines. Strategic-level thinking is essential, as is exceptional judgment. Must be energized by working in a dynamic environment.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Serving as a key legal advisor on commercial activities involving specialty medicines in the US market, with a strong focus on advising on the promotion, sale, and distribution of specialty medicines
Providing significant product support as a brand lawyer with expertise advising on both promotional and non-promotional initiatives across a highly matrixed organization. The role requires substantial depth in the fundamentals of FDA advertising and promotional rules, regulations, and guidance expectations. The ability to issue spot and collaborate with legal subject matter experts and other legal colleagues is critical
Advising on a wide-range of US commercial programs supporting specialty medicines, with a strong working knowledge of relevant fraud and abuse laws and regulations
Counseling on the external legal environment relating to operating a specialty business, with a clear understanding of industry practices
Engaging with cross-functional teams and matrix partners (e.g., Medical Affairs, Communications, Commercial Operations, Regulatory) to drive agendas and effectively communicate complex information in clear and concise terms
Partnering with the Compliance function to ensure policies and standard operating procedures are fit-for purpose, with clear organizational understanding and pull through
Managing outside counsel in limited circumstances
Key deliverable: effective counseling of the US Specialty and Oncology Business Units to support successful performance by driving strategic initiatives, while also ensuring activities and programs are compliant with the US legal framework
We are looking for professionals with these required skills to achieve our goals:
U.S. Juris Doctor (J.D.)
Current member of a state bar
Minimum of 5 years relevant experience
Experience in US FDA promotional laws/regulations
Working knowledge about specialty medicines, including legal framework related to specialty commercial programs
If you have the following characteristics, it would be a plus:
Excellent interpersonal skills demonstrated through interactions with team, clients third-parties
Strong leadership/management skills
Ability to engage proactively across a broad range of client groups
We are a science-led global healthcare company. We research and develop a broad range of innovative products in three primary areas of Pharmaceuticals, Vaccines and Consumer Healthcare.
We also have a significant global presence with commercial operations in more than 150 countries, a network of 64 manufacturing sites in 31 countries and large R&D facilities in the UK, USA, Spain, Belgium and China.
Mission: At GSK we are on a mission to help people do more, feel better, live longer. We know that healthy communities depend on healthy people, and healthy communities are the backbone of strong, sustainable societies. As a business we have responsibilities to society, and society has expectations of us. Our goal is to meet those responsibilities and expectations – and, where possible, exceed them.