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    

Preferred Qualifications:

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