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ProfileCompliance Attorney, Pharmaceuticals Candidate's 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. Duties also include supporting commercial business units with the review and assessment of advertising and promotional issues through participation in the Medical Legal Regulatory (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. Will report to the head of healthcare compliance North America and work with the members of sons promotional review committee, referred to as the HC 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.
Qualification and Experience
Candidate should have a BS/ BA degree and JD degree. Candidate should have 5-10 years of broad experience in pharmaceutical industry and/or with pharmaceutical manufacturer activities. 5 years of direct experience conducting legal reviews of advertising and promotional content and practical experience in interpretation of industry regulations and guidance documents is needed. Demonstrated knowledge of regulations and regulatory guidance specific to advertising and promotion of pharmaceutical/biological products is required. 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. Knowledge of FD&CA, Anti-Kickback Statute, False Claims Act, Foreign Corrupt Practices Act, PDMA, FDAAA, HIPAA, state laws is a must. Regulations industry guidance and best practices regarding compliance sales marProficiency Microsoft office is required.
Sun Pharmaceutical Industries Ltd.
600 College Road East
Princeton, NJ 08540