This position will be based at the Alexion site in Boston, MA, and may require up to 10% travel.

This is what you will do:

• We are seeking an Associate Director, US Commercial Counsel to join the Alexion US Commercial Law Practice Group.  This role will serve as the primary legal partner for one or more of our key products and will also serve as a primary point of contact for key US commercial and medical affairs functions. 
• The ideal candidate must have a deep understanding of US healthcare laws as they relate to the advertising, promotion, and distribution of prescription drugs. 
• This role will routinely interact with senior US management and will be required to work across a number of Alexion functional groups.  The ideal candidate must have strong communication and collaboration skills, be proactive and be able to work independently while managing multiple projects and clients. 

You will be responsible for:

• Routinely partnering with senior leadership over the assigned therapeutic area and function(s) to incorporate legal advice into brand planning and long-range strategy, including:
  • Giving input into product launch planning
  • Advising on major brand, commercial, and medical initiatives
  • Providing input on healthcare compliance annual planning processes
• Providing front-line support to headquarters and field-based personnel in the assigned therapeutic area and function(s), including:
  • Counseling key stakeholders to ensure compliance with key healthcare laws, regulations, and guidance, including the Federal Food, Drug & Cosmetic Act, the Anti-Kickback Statute (AKS), the False Claims Act (FCA), HHS-OIG guidance, FDA regulations and guidance, and the PhRMA Code on Interactions with Healthcare Professionals
  • Serving as the lead reviewer for promotional, educational, and training materials for the assigned therapeutic area and function(s)
  • Partnering with the Alexion Compliance function to continuously assess and mitigate healthcare compliance risks relating to the assigned therapeutic area and function(s)
  • Advising on internal policy and process matters relating to the assigned therapeutic area and function(s)
  • Helping to coordinate input from internal legal experts as needed (e.g., input from in-house counsel focusing on privacy, clinical research, human resources, securities laws, etc.)
• Working with the Alexion contracts group to ensure that the routine contracting needs for the assigned therapeutic area and function(s) are met in a timely and efficient way