POSITION SUMMARY:

The Commercial/Contracts and Healthcare Compliance Counsel will work closely with sales, marketing, regulatory affairs and across multiple other internal functional groups and cross-functional teams.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• 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, but not limited to 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.

EDUCATION AND EXPERIENCE:

• J.D. degree from a national law school and strong academic credentials
• 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
• 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
• Strong understanding of medical device, biotech or pharmaceutical operations and the ability to create policies and programs that work for the business
• Great negotiating skill, ability to prioritize, handle multiple tasks and work independently under tight deadlines
• Proven track record of delivering independently and consistently on complex projects under challenging circumstances
• Ability to communicate effectively both verbally and in writing in both individual and group settings