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Years of Experience
Date Last Verified
ProfileCompliance Counsel Duties: Supporting commercial business units with the review and assessment of advertising and promotional issues 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
Qualifications: BS/BA degree required. Jurist 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. 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. Knowledge of FD&CA, Anti-Kickback Statute, False Claims Act, Foreign Corrupt Practices Act, PDMA, FDAAA, HIPAA, state laws. Regulations industry guidance and best practices regarding compliance sales marketing medical affairs activities. Must possess strong verbal written presentation and other communication skills. Ability to fully gauge various audiences. Proficiency Microsoft office is required. Must be self-motivated and possess strong interpersonal skills.
Sun Pharmaceutical Industries Ltd.
600 College Road East
Princeton, NJ 08540