Senior Compliance Manager
Key Responsibilities:
- Build and scale a modern, comprehensive compliance program, including the integration of AI-enabled tools to drive efficiency and effectiveness.
- Serve as the compliance/legal representative in promotional and medical review processes (e.g., MLR), ensuring alignment with federal promotional standards and industry codes.
- Provide strategic guidance on critical U.S. healthcare compliance laws, including the Anti-Kickback Statute, on‑label promotion requirements, open payments, and related regulatory expectations.
- Lead the design and execution of internal investigations, monitoring plans, and ongoing compliance oversight across commercial and medical activities.
- Develop and deliver engaging, business‑specific compliance training programs across digital and live platforms.
Qualifications:
- 5-8+ years of corporate compliance experience within pharmaceutical, biotech, or medical device companies with marketed products; Bachelor's degree required.
- Deep expertise in key healthcare compliance frameworks, including AKS, federal program rules, FDA promotional standards, and industry codes (e.g., AdvaMed, PhRMA).
- Demonstrated success implementing AI solutions to strengthen compliance review processes or operational efficiency.
- Exceptional communication skills, sound judgment, and the ability to operate autonomously within a fast-paced, multidisciplinary environment.
- Proficiency with compliance and data systems, including MS Office, content management platforms, CRM/compliance systems, and aggregate spend tools.
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