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Carrot Peelers, Sales, Personality and Your Job Search
In-House
Attorney
Health Care
5-10 yrs required
Healthcare Compliance Attorney The candidate will report to the head of healthcare compliance North America and work with the members of Sun's promotional review committee, referred to as the HCNA in a Medical Legal Regulatory (MLR) committee, to ensure completion of legal and healthcare compliance reviews of commercial and medical submissions to the MLR committee. Responsibilities include providing overall assistance in reviewing sales marketing and commercial activities through the promotional and medical review process to ensure that materials and tactics are compliant with company policies and legal requirements. Essential Job Functions: Supporting commercial business units with the review and assessment of advertising and promotional materials through participation in the MLR review committee. Assessing disease state and medical materials through the MLR review committee. Providing healthcare compliance guidance for various therapeutic areas including Dermatology, Biologics, Neuroscience, Oncology and Ophthalmology. Advising company executives on healthcare compliance policies procedures and laws. Collaborating with Medical and Regulatory Affairs to conduct a detailed review and evaluation of the adequacy of promotional claims and tactics to ensure consistency with FDA approved labeling.
Qualification and Experience
A BS/BA degree required. Juris doctorate degree required. 5-10 years broad experience in pharmaceutical industry and/or with pharmaceutical manufacturer activities is a required. 5 years direct experience conducting legal reviews of advertising and promotional content and practical experience in interpretation of industry regulations and guidance documents is needed. Should have demonstrated knowledge of regulations and regulatory guidance specific to advertising and promotion of pharmaceutical/biological products. Must have knowledge and experience to act upon compliance issues related to sales marketing and medical affairs activities. Also, Government programs, federal healthcare program reporting, continuing medical education programs, and overall business ethics programs. Should have knowledge of FDA, Anti-Kickback Statute, False Claims Act, Foreign Corrupt Practices Act, PDMA, FDAAA, HIPAA, state laws. Regulations, industry guidance, and best practices regarding compliant sales marketing and medical affairs activities is required. Must possess strong verbal written presentation and other communication skills. Proficiency in Microsoft office is required.
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