Description:

Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.

Responsibilities:
  • Serve as strategic business partner to the product team
  • Serve on the review committees for promotional materials and medical materials
  • Provide legal counsel to commercial organization, including in respect of commercial program design, implementation and compliance with Federal and state anti-kickback statutes, false claims acts, the Food, Drug and Cosmetic Act, HIPAA, product liability law, product reimbursement
  • Advise on contract drafting and negotiation
  • Provide risk management, mitigation counseling and brand planning management.
  • Advise on promotional materials, disease awareness, field team training, social media communications, patient services, speaker programs, labeling, lifecycle management
  • Medical Affairs support:
  • Advise on materials and interactions of Medical Science Liaisons
  • Research and Publication planning
  • Medical Information support
  • Health Economic and Outcomes Research
  • Coordination with Commercial organization as pipeline candidates are developed and commercial launch planned.

Qualifications:
  • 10+ years' experience in the bio/pharma life sciences department of a leading law firm and/or an in-house corporate position with a multinational corporation.
  • Strong technical background in the commercialization of biotechnology/pharmaceutical products.
  • Experience with FDA regulations, federal anti-kickback, false claims act statutes and HIPAA.
  • Must have excellent interpersonal, decision making and communication skills.

Education:
JD from an accredited law school