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Commercial/contracts And Healthcare Compliance Counsel
Refer job# EWWS146308
 
Commercial/Contracts and Healthcare Compliance Counsel The candidate will work closely with sales, marketing, regulatory affairs and across multiple other internal functional groups and cross-functional teams. Will draft, review, and negotiate various agreements, including domestic and international distribution agreements, specialized product purchase/use agreements with physicians, manufacturing/supply contracts with suppliers of materials or services, professional services agreements, consulting agreements, branding/marketing/PR agreements, joint venture agreements, consents/permissions forms, confidentiality agreements, and other miscellaneous contracts and corporate documents. Work collaboratively with company management and various business units to support commercial and corporate activities. Guide interdisciplinary teams on health care compliance and provide legal advice on daily activities. Provide risk management, mitigation counseling. Help develop corporate business and compliance policies and practices, participate in field team training and review of promotional materials. Advise on applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, patients, advocacy groups and other business partners, including compliance with Federal and state anti-kickback statutes, False Claims Act, the Food, Drug and Cosmetic Act, HIPAA and product liability law. Manage contract database.

The candidate should have a JD degree from a national law school and strong academic credentials. Must have 7+ years of hands-on legal experience supporting corporate and commercial contracting activities and healthcare compliance activities. Leading law firm and/or in-house medical device/biotechnology/pharmaceutical industry experience is required. Should be an active member of the California State Bar or California State Bar eligibility. Strong knowledge of contract documents and concepts and strong drafting skills, attention to details is important. Understanding of, and experience with, regulatory framework applicable to interactions with healthcare professionals, patient privacy and related issues essential. Strong understanding of medical device, biotech or pharmaceutical operations and the ability to create policies and programs that work for the business is needed.
 
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