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.

Responsibilities:

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 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

Relevant Capabilities and Experience

• 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

Qualifications

• Bachelors degree; strong preference for Masters 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 AdvaMed 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 visualization tools is a plus

• Strong critical analysis and problem-solving skills
• Strong project management skills and aptitude to manage and mentor others
• Excellent organizational and management skills
• Ability to manage multiple time-sensitive priorities without diminished effectiveness
• Strong communications skills including both written and verbal
• Collaborative and team oriented

• Ability to conduct business development activities and meetings to generate new clients and increase existing engagements

Work Requirements

• Ability to work from a virtual/home office without distraction and maintain responsibility for achieving utilization goals
• Ability to travel and work in a fast-paced and at deadline-driven environment balancing multiple projects and managers
• Attendance at in-person team meetings on-camera virtual team meetings and onsite work at client locations
• Capability to independently arrange and engage in frequent travel across the US (and internationally as needed)

Base Pay Range*

*The base pay range is subject to change and may be modified in the future.

The pay range is the base pay compensation range that Dovetail Consulting Group LLC expects to pay for this position at the time of this posting. Individual compensation within this range depends on multiple factors including but not limited to candidates prior education and relevant work experience and training as well as position location and local market demands. Our pay-for-performance culture also includes participation in an annual incentive bonus plan for this position which is not included in the Base Pay Range noted above. We offer a competitive benefits package that offers eligible employees medical dental and vision insurance life and disability insurance HSA contributions and a 401(k) with employer contributions.

Equal Opportunity Statement:

Dovetail Consulting Group LLC is an Equal Opportunity Employer. Qualified applicants will receive consideration without regard to race color religion sex sexual orientation gender identity or expression national origin age disability veteran status marital status or other non-merit factor. Applicants requiring a reasonable accommodation to participate in the hiring process may contact us at .

Required Experience:

Manager