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Assistant Regulatory Counsel The candidate will be responsible for providing timely, high quality legal services in the regulatory area supporting the company's global Regulatory and Quality Affairs, Manufacturing, R&D, and Sales & Marketing organizations. Additional Responsibilities Include: Provide counsel and advice to company on both U.S. and ex-U.S. laws and regulations impacting the pharmaceutical industry, including product quality standards, and product development and filing requirements. Provide counsel and advice to company on promotional materials based on the regulations governing advertising and promotion, including medical/scientific activities. Track and evaluate state legislative initiatives applicable to pharmaceutical companies, including marketing and compliance activities in those states. Provide counsel and advice to company on pending federal legislative initiatives impacting the pharmaceutical industry. Perform special projects as required.
Qualification and Experience
A Bachelor's degree (or equivalent) and a Juris Doctor degree and 2-4 years of experience will be required. Must be licensed in one or more jurisdictions. However, a combination of experience and/or education will be taken into consideration. Experience in the Medicare and Medicaid fraud and abuse, HIPPA, Stark, and Antitrust experience is preferred. Experience in reviewing pharmaceutical promotional materials and interaction with the FDA's Division of Drug Marketing, Advertising and Communications is preferred. Should have experience in regulatory issues related to the pharmaceutical industry.
Position Reference Code: MLI_12_002312.
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