Product Counsel, Alkermes

Alkermes plc (Nasdaq: ALKS) is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases and immuno-oncology. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for diseases that include schizophrenia, depression, addiction, multiple sclerosis 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.
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• Must have excellent interpersonal, decision making and communication skills.
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• Education:
• JD from an accredited law school

To Apply:

https://phe.tbe.taleo.net/phe01/ats/careers/v2/viewRequisition?org=ALKERMES&cws=41&rid=11438&source=LinkedIn&src=LinkedIn&gns=LinkedIn