Products Counsel
Waltham, MA 
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Posted 27 days ago
Job Description

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.
  • Must have excellent interpersonal, decision making and communication skills.
    Education:
  • JD from an accredited law school

#LI-KO1

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.

Experience Level:
Director

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

 

Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
10+ years
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