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In-House
Attorney
Health Care
Litigation - Whistleblower - CFTC
Min 5 yrs required
Associate Director and Corporate Counsel - Commercial Responsibilities: Be responsible for providing guidance and support on privacy, commercial and healthcare issues. Provide general Commercial, Healthcare and Privacy Advising. Review and advise on internal and external communications related to patient services and product support services. Support development of a training program for patient services case managers. Review commercial communications, such as advertising and promotional materials, with a focus on DTC materials. Draft and negotiate commercial contracts and supervise work of paralegals in legal research, writing and contract negotiation. Support review of product labeling materials and regulatory communications. Advise on fraud and abuse issues such as Anti-Kickback, False Claims, and compliance with OIG guidance. Advise on and support responsible corporate communications relating to patient services and other commercial functions. Perform legal research and develop/amend/implement various company policies addressing privacy and security of patient information and global privacy issues. Counsel Patient Services Program and Compliance on domestic and international privacy matters. Draft and implement contractual terms to ensure compliance with applicable privacy and security laws and Global Privacy Policy. Monitor and advise on changes in privacy laws, including HIPAA and HITECH, that impact the business. Interact with and manage outside counsel work product. Investigate and advise on suspected privacy concerns and complaints, including regarding patient services. Annually execute gap assessment and recertification under Department of Commerce US-EU-Swiss Safe Harbor Framework and support global training and policy development related to Safe Harbor compliance.
Qualification and Experience
Qualifications: Law degree from a nationally recognized law school and current admission to the Bar. 5+ years’ experience in privacy, healthcare, and pharmaceutical practice areas, with large law firm experience strongly valued. Experience in commercial life sciences, as well as to those with in-house corporate experience in a multinational pharmaceutical corporation. Experience with patient services. Strong working knowledge of laws, regulations, and industry guidance that affect the global marketing of pharmaceutical products, including federal and state government price reporting laws, fraud and abuse and anti-kickback statutes, OIG and PhRMA guidelines, state marketing compliance laws, and anti-bribery laws. Knowledge of EU-US-Swiss Safe Harbor Framework and experience with ex-US privacy issues (especially Canada, Europe and Australia). Proficiency in Spanish or Portuguese language.
AutoReqID: 6198BR
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