Full TimeRemote
About the company: Established growth-mode compliance consulting firm serving compliance departments and executives across biotechnology, medical device, and pharmaceutical industries.
Why Join Us:
- High-impact compliance work at a dynamic and growing firm with a singular focus on quality and substance
- Direct exposure to client executives, compliance leaders, and business leaders at clients ranging from pre-commercial to some of the largest life sciences firms in the world
- Opportunity to gain exposure to all aspects (seven elements) of compliance work from day one
Responsibilities:
- Reporting to Directors and Partners who will provide mentorship training where needed, you will join a dynamic team to help build, enhance, and manage healthcare compliance and risk management programs at a variety of life sciences clients
- Serve as a key contributor across both client engagements and internal operations, bringing critical thinking and subject matter expertise to a broad range of compliance-related activities
- Critically analyzing existing healthcare policies and procedures to identify gaps and opportunities for improvement
- Drafting and revising internal controls to help clients improve the strength and efficiency of compliance-involved operations
- Supporting enterprise and healthcare compliance risk assessments
- Developing and delivering compliance training
- Conducting live and transactional monitoring of client processes
- Leading audit readiness initiatives, including mock interviews and audit preparedness reviews
- Conduct interviews pertaining to compliance processes
- Drafting and refining senior-level management reports across a variety of formats and applications
- Developing project plans and managing cross-functional teams
- Evaluating and improving business processes for efficiency and effectiveness
- Analyzing and improving process controls that support compliance objectives
Requirements:
- Essential education: Bachelor's degree
- Preferred education: Advanced degree, such as Master's in a related field or JD
- Substantial healthcare compliance experience in pharmaceutical, biotech, or medical device organizations, either from in-house compliance role/s or from compliance consulting firm work (or a combination of the two)
- Thorough understanding of HHS-OIG Compliance Program Guidance, DOJ Evaluation of Corporate Compliance Programs, the PhRMA Code, AdvaMed Code, and other industry codes
- Working knowledge of the Anti-Kickback Statute (AKS), False Claims Act (FCA), FDA promotional regulations, and international compliance codes
- Strong critical analysis, problem-solving, and project management skills, with the ability to manage and mentor others
- Ability to work independently from a virtual/home office while meeting utilization goals, and to travel 10-15 % of your time across the US to client sites and team meetings
