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Health Care/Counsel/In House/New Brunswick, New Jersey

Company Name:
BITSOFT INTERNATIONAL, INC.
Senior Counsel, Regulatory Law
The candidate will provide legal support to client groups in the pharmaceutical sector. Will be responsible for advising clients on FDA regulatory matters and compliance with laws, regulations and company policies in the areas of advertising and promotion, clinical research, product development, and quality. Provide strategic legal advice and counsel on U.S. Health Care Fraud and Abuse Laws, including the Federal Anti-Kickback Statute, and related health care legal obligations. Advise on marketing and sales activities and programs, including review of advertising materials, and will work with clients on developing appropriate and compliant strategies for interacting with health care providers and payors. Advise clients on life cycle management strategies, and on research and development programs, including the co-development of drugs and diagnostics.

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