We are seeking an Associate Director, US Commercial Counsel to join the Alexion Global Pipeline and US Commercial Law practice group. This position will report to the Director, Global Pipeline and US Commercial Counsel for our Complement and Coagulation therapeutic areas. This role will serve as the primary legal partner for our Complement therapeutic area and may also serve as a primary point of contact for one or more of our cross-franchise US Commercial and/or 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 the US Commercial and Medical Affairs teams and will be required 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.
Job Duties & Responsibilities
Routinely partner 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
Provide 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.)
- Work 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
- 4+ years of legal expertise
- Substantial expertise advising on healthcare compliance and advertising/promotion-related issues for pharmaceutical or medical device companies
- Prior experience advising at the senior executive level
- Strong communication skills
- Ability to work in a matrixed environment
- Eligible to practice law in the United States
- 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 and devastating conditions through the discovery, development and commercialization of life-changing medicines. As a leader in rare diseases for more than 25 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat 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) as well as the first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. 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, metabolic disorders and cardiology. Headquartered in Boston, Massachusetts, Alexion 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.
To apply for this job please visit www.goinhouse.com.