Senior Director/Head of Healthcare Compliance, Healthcare Consulting Firm, Washington DC or Remote
Company Overview
The leading medical device, diagnostics, and biologics advisory firm and clinical research organization (CRO). Our value contribution rests within its industry experience at integrating five business value creators—regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance—to provide a dynamic, market-leading effort from concept to commercialization. Our integrated application of these key value-creating functions provides unparalleled expertise for its clients. We have offices in Washington, DC, Manchester, CT, New York, NY, and a global presence in Japan and Europe and serves more than 1100 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, neurology, digital health, diagnostic imaging, wound care, dental, general healthcare, robotics, and in vitro diagnostic (IVD) devices.
Position Overview
A leading medical device consulting firm is currently seeking a Healthcare Compliance Attorney (exact level/title will depend on candidate’s experience) to join as a working leader for the firm’s Healthcare Compliance division. This will be a billable consulting position supporting the Company and its clients with all healthcare compliance inquiries and initiatives.
Primary responsibilities will be interfacing with clients to provide expert consultation on healthcare compliance, conducting investigations & audits, maintaining & monitoring compliance policies and procedures, contract management & negotiation, and business development support to drive the growth and success of our compliance team.
The ideal candidate will have strong experience in healthcare compliance, preferably from the law firm setting, with rich exposure to the medical technology industry. This role will involve compliance services for companies & manufacturers as well as healthcare providers, hospitals, and related industry organizations.
Responsibilities
- Serve as healthcare compliance and ethics subject matter expert on internal and external/client projects.
- Provide consulting/advising to client companies, which may include the preparation of written deliverables, assessments, and analyses.
- Act as a valuable member of project teams to solve complex compliance challenges and offer clients with novel solutions and ideas.
- Conduct audits & investigations as project needs dictate.
- Develop and implement compliance and privacy policies & procedures.
- Create both strategic and tactical compliance recommendations.
- Provide compliance program development as required by clients.
- Provide training on compliance program and business ethics, both internally and externally, as required.
- Serve as Compliance and/or Privacy Officer to clients as needed.
- Provide expert-level consulting in the areas of Compliance Resource Center Management, sanction screening, patient privacy, conflict of interest management, etc.
- Contribute compliance expertise to business development efforts for new and existing clients, including conceptualizing of project scope from initiation to client delivery.
- Stay abreast of current trends in healthcare compliance with continuing education etc. as needed and/or required.
- Participate in business development calls and related meetings as needed Ensure all work products comply fully with standards, policies, and mission of MCRA.
Required Qualifications
- Juris Doctor (JD), Esquire (Esq) or similar law degree required.
- 3-8+ years of experience working directly in healthcare compliance in a law firm or similar setting.
- Specific compliance experience within medical devices is highly preferred.
- Comprehensive understanding of the appropriate compliance policies, regulations, HIPAA, etc. related to the healthcare and medical technology industries.
- Ability to read, analyze, and interpret complex documents.
- Ability to solve complex compliance issues and provide expertise in a timely and appropriate manner with minimal management oversight.
- Experience with customer relations and managing client relationships.
- Ability to effectively establish personal credibility as a strategic compliance expert with clients.
- Ability to handle multiple tasks and meet deadlines while working independently or as an active member of a team.
- Project management experience that includes interacting with and presenting to both internal and external stake holders (executives, C-suite, health policy leaders, etc.).
- Strong interpersonal skills that translate into positive relationships with colleagues and clients.
- Strong technical ability with fluency in Microsoft Office Suite products (Outlook, Word, Excel, PowerPoint, etc.).
- Accurate and precise with exemplary attention to detail.
- Ability to multitask, prioritize, and manage time efficiently.
- Excellent verbal and written communication skills and presentation ability.
Compensation & Benefits
- Salary + bonus
- Medical, dental, and vision insurance
- Company-paid life insurance
- Company-paid STD and LTD
- 401(k)
- Generous PTO policy
- Fully paid parental leave benefits
- Pre-tax public transit and parking benefit
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as to meet the ongoing needs of the organization.
Application Process for Senior Director/Head of Healthcare Compliance:
Qualified professionals are to submit resume to Heather Smith: heather@conselium.com
