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
