Director, Compliance Counsel

Alternative Resources Company

Director, Compliance Counsel

Director, Compliance Counsel
 
Compliance Counsel will report to the Head of Healthcare Compliance North America (HCNA) and work with members of the promotional review committee, referred to as the HCNA 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.
 
Responsibilities
  • 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
 
Qualifications
  • BS/BA degree required; Juris Doctorate degree required
  • 5 – 10 years broad experience in pharmaceutical industry and/or with pharmaceutical manufacturer activities
  • 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/ biologic products
  • 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
  • Ability to fully engage various audiences
  • Proficiency in Microsoft Office is required
  • Must be self-motivated and possess strong interpersonal skills