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
You will need to have:
3+ years of legal experience
Substantial expertise advising on healthcare compliance and advertising/promotion-related issues for pharmaceutical or medical device companies
Prior experience advising senior executives
Strong communication skills
Ability to work in a matrixed environment
Eligibility to practice law in the United States
The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have:
Prior in-house experience in the pharmaceutical industry
Prior experience advising on products for rare or ultra-rare conditions
Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) as well as the first and only approved complement inhibitor to treat atypical hemolytic uremic syndrome (aHUS), anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders..., hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing several mid-to-late-stage therapies, including a second complement inhibitor, a copper-binding agent for Wilson disease and an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases as well as several early-stage therapies, including one for light chain (AL) amyloidosis and a second anti-FcRn therapy. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes' list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.