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Carrot Peelers, Sales, Personality and Your Job Search
In-House
Attorney
Health Care
Litigation - Whistleblower - CFTC
Min 3 yrs required
Compliance Counsel Duties: Will work with the Head of Healthcare Compliance. Assist with the implementation and effective operation of the comprehensive compliance program for the sales, marketing, medical affairs, market access and other commercialization functions. Responsibilities include providing overall assistance to ensure that sales, marketing and commercial activities are compliant with ethical and legal obligations by assisting with the implementation of compliance policies and procedures, ensuring that SPII has addressed appropriate risk areas, providing daily guidance to all company personnel on policy interpretation, developing and delivering appropriate training, conducting routine monitoring, coordinating and conducting investigations to ensure that complaints and concerns are adequately investigated and addressed, and assisting with department and enterprise-wide compliance projects and initiatives. Assist the Head of HCNA with establishing the comprehensive compliance program. Ensure compliance with various state laws pertaining to marketing and medical activities. Provide compliance guidance and training to stakeholders with respect to applicable laws, regulations, company policies, SOPs, and industry guidance. Prepare engaging and interactive compliance training /presentations for various stakeholders (e.g., sales personnel, contractors, etc). Draft procedural documents (Code of Conduct, policies, SOPs, WIs, forms) to effectuate a comprehensive compliance program. Conduct investigations of identified non-compliance or misconduct, participate in a committee that reviews investigations and recommended actions, provide input for corrective actions and preventative measures. Prioritize projects and departmental deliverables in order to ensure compliance with procedures and customer satisfaction. Provide assistance with various monitoring and auditing activities as needed.
Qualification and Experience
Qualification Requirements: A BS/BA degree. A Juris Doctorate degree and 3 years of direct compliance experience and practical experience in interpretation of industry regulations and guidance documents. 5-10 years broad experience in pharmaceutical industry and/or with pharmaceutical manufacturer activities. Must have knowledge and experience to act upon compliance issues related to sales, marketing and medical affairs activities, government programs, federal healthcare program reporting, continuing medical education programs, and overall business ethics programs. Knowledge of laws (FD&CA, 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, medical affairs activities, primarily through experience in the pharmaceutical industry and/or with pharmaceutical manufacturer activities. Must possess strong verbal, written, presentation, and other communication skills. Must be self-motivated and possess strong interpersonal skills. Ability to fully engage various audiences.
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