Director, Commercial Counsel
Alkermes
5 hours ago
Remote friendly (Greater Boston)
United States
Corporate Functions
Responsibilities:
- Serve as strategic business partner to the assigned brand team and the market access team.
- Provide legal support as a key member of the review committees for promotional materials and medical materials for the assigned brand team.
- Prepare, review, and negotiate complex payer, pharmacy and distributor agreements, including agreements with commercial and government payers, PBMs, GPOs, retail, specialty and long-term care pharmacies, wholesalers, and specialty distributors.
- Interpret and apply federal and state laws (e.g., FDCA, False Claims Act, anti-kickback statute) and laws/regulations relating to Medicaid, Medicare, 340B, and Veterans Health (VA) Care programs.
- Partner with Compliance to assist and counsel in developing policies, procedures, legal guidance documents, tools, and training materials.
- Develop deep knowledge of the business and evolving legal/regulatory landscape impacting the assigned brand and market access.
Qualifications:
- 5+ years’ experience in the bio/pharma life sciences department of a leading law firm and/or an in-house corporate position.
- Strong technical background in commercialization of biotechnology/pharmaceutical products.
- Experience with FDA regulations and federal anti-kickback and False Claims Act statutes and/or contracting with private payors and government healthcare programs (Medicaid, Medicare, VA, 340B).
- Excellent analytical skills; ability to independently identify practical legal solutions and work effectively in matrixed environments.
- Superior written and verbal communication skills to convey complex legal and business concepts to business stakeholders.
- Ability to work collaboratively and in accordance with company values.
Education:
- JD from an accredited law school
Work model / location:
- Hybrid: 60% office / 40% from home; onsite at Waltham, MA office at least 3 days per week; not eligible for fully remote work.
- Serve as strategic business partner to the assigned brand team and the market access team.
- Provide legal support as a key member of the review committees for promotional materials and medical materials for the assigned brand team.
- Prepare, review, and negotiate complex payer, pharmacy and distributor agreements, including agreements with commercial and government payers, PBMs, GPOs, retail, specialty and long-term care pharmacies, wholesalers, and specialty distributors.
- Interpret and apply federal and state laws (e.g., FDCA, False Claims Act, anti-kickback statute) and laws/regulations relating to Medicaid, Medicare, 340B, and Veterans Health (VA) Care programs.
- Partner with Compliance to assist and counsel in developing policies, procedures, legal guidance documents, tools, and training materials.
- Develop deep knowledge of the business and evolving legal/regulatory landscape impacting the assigned brand and market access.
Qualifications:
- 5+ years’ experience in the bio/pharma life sciences department of a leading law firm and/or an in-house corporate position.
- Strong technical background in commercialization of biotechnology/pharmaceutical products.
- Experience with FDA regulations and federal anti-kickback and False Claims Act statutes and/or contracting with private payors and government healthcare programs (Medicaid, Medicare, VA, 340B).
- Excellent analytical skills; ability to independently identify practical legal solutions and work effectively in matrixed environments.
- Superior written and verbal communication skills to convey complex legal and business concepts to business stakeholders.
- Ability to work collaboratively and in accordance with company values.
Education:
- JD from an accredited law school
Work model / location:
- Hybrid: 60% office / 40% from home; onsite at Waltham, MA office at least 3 days per week; not eligible for fully remote work.