Manager, Life Sciences​/Healthcare Compliance Consulting

Title:

Manager, Life Sciences / Healthcare Compliance Consulting

Location:

Boston, MA;
Chicago, IL;
Denver, CO, Atlanta, GA, or San Francisco, CA areas strongly preferred

Full Time/Part Time:
Full Time

Regular/Temporary:
Regular Employer Information:

Dovetail Consulting Group, LLC serves compliance departments and biotechnology, medical device, and pharmaceutical company executives by helping them optimize performance and minimize compliance risk across the life sciences industry. Our professionals possess extensive knowledge of compliance requirements, processes, and operations, including in the areas of:

• Strategic healthcare compliance program (pharma/biotech) development and implementation
• Board advisory and expert services
• Compliance, privacy, and corporate policy drafting and globalization
• Role-based compliance and privacy guidance and training
• Promotional/commercial and non-promotional/medical interactions, including medical-commercial collaboration
• External funding arrangements
• Fee for service (FFS) arrangements with healthcare professionals (HCPs)
• Patient support program (PSP) compliance
• Medical Affairs and Clinical programs (e.g., MSL activities, publications, investigator-sponsored trials)
• Privacy and enterprise risk management

Our combination of deep industry knowledge and functional expertise enables us to provide professional services and support for complex projects, including CIA readiness assessments, merger and acquisition analyses, and executives and board education.

Dovetail is seeking an experienced healthcare compliance consulting Manager (per consulting title convention) to join our dynamic team to help build, enhance, and manage healthcare compliance and risk management programs. In this role, the Manager will serve as a key contributor across both client engagements and internal Dovetail operations, bringing critical thinking and subject matter expertise to a broad range of compliance-related activities.

Candidates without direct experience in consulting, pharmaceutical, biotechnology, or medical device compliance will not be considered.

Core responsibilities include:

• Critically analyzing existing healthcare policies and procedures to identify gaps and opportunities for improvement
• Helping clients strengthen internal controls and improve the efficiency of compliance-involved operations
• Working independently and collaboratively to support client engagements across a variety of service areas, including:
  • Compliance program gap analyses
  • Healthcare compliance risk assessments and internal controls evaluations
  • Audit preparedness and mock interview sessions
  • Compliance training development and delivery
  • Stakeholder interviews and strategic management analyses
  • Compliance benchmarking assessments
    
    Advisory support on healthcare compliance matters

• Conducting enterprise and healthcare compliance risk assessments
• Developing and delivering compliance training
• Leading audit readiness initiatives, including mock interviews and audit preparedness reviews
• Conduct interviews pertaining to compliance policy and processes
• Drafting and refining senior-level management reports across a variety of formats and applications
• Navigating and influencing a matrixed organization
• 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
• Communicating clearly and effectively in writing; ability to produced polished work product independently while contributing collaboratively with a busy team

• Bachelor's degree; strong preference for Master's degree in a related field or JD
• Authorized to work in the US
• 4+ years of healthcare compliance experience in pharmaceutical, biotech, or medical device organizations, prior consulting or professional services experience focused on the life sciences, or government agency (e.g., HHS-OIG or DOJ) relevant to healthcare compliance is required
• Thorough understanding HHS-OIG Compliance Program Guidance, DOJ Evaluation of Corporate Compliance Programs, the PhRMA Code, Adva Med Code and other industry codes are required
• Working knowledge of Anti-Kickback Statute (AKS), False Claims Act (FCA), FDA promotional regulations and International Compliance Codes is required
• Excellent knowledge and demonstrated capabilities using the Microsoft Office suite of tools (e.g., Excel, PowerPoint, Project, Visio)
• Familiarity with data…