Compass Consulting · 4 hours ago
Head of Legal Compliance
United States
Full-time
Remote
Director/Executive
$275K/yr - $300K/yr
10+ years expCompass Consulting has been in operation for over 20 years, developing deep expertise in the science of expanding and enhancing cells. They are seeking a Head of Legal Compliance, Associate General Counsel (AGC) who will oversee and support Legal and Compliance activities with a focus on the US commercial business and daily business activities.
BiotechnologyConsultingLife ScienceMedical DevicePharmaceuticalRecruitingStaffing Agency
Hiring Manager
Lexie Pierce
Responsibilities
Provide strategic legal guidance on FDA law and regulations, anti-kickback statute, federal False Claims Act, and product liability matters to various functions (including with sales, marketing, medical affairs, market access, patient services, patient advocacy, and others) regarding product launches, brand planning, life-cycle management, and other initiatives
Provide legal review of promotional and non-promotional materials to ensure compliance with all relevant laws, regulations, industry guidance and company policies (i.e., Legal point on “MLR” a/k/a “PRC”)
Collaborate with company leadership and employees at all levels to develop, implement and evolve a well-designed healthcare compliance program that works in practice
Provide operational input and legal advice on Federal Sunshine Act and state transparency reporting processes, including coordinating with Finance, and outside service providers, and other relevant functions to review data and manage an effective state and federal transparency reporting process; there is also a chance to shape the way the company thinks about this reporting, including education and counseling within the organization
Develop, implement and manage a business-enabling contracting process/system
Draft, negotiate, revise, and improve certain global healthcare and US business contracts including but not limited to CDA, MSA, collaboration agreements, investigator-initiated study agreements, supply chain agreements, and consulting agreements. Draft, and support in negotiation of, a variety of contracts (services agreements and commercial contracts with 3PLs, distributors, wholesalers, payors, specialty pharmacies, grants, sponsored research, speaker/consultant, licensing, collaboration, employment-related, leases, etc.)
Implement and serve as Chair of Compliance Committee. Routinely report on Compliance Program and key findings to leadership
Help maintain compliance with the seven elements of a compliance program per OIG guidance
Develop and manage internal auditing and monitoring program, including, but not limited to, field ride alongs, speaker program monitoring, and advisory board monitoring
Implement written healthcare compliance policies and procedures, and continuously assess the need for revisions
Prepare and deliver compliance trainings, along with training plans for the organization
Conduct internal investigations. Engage and manage outside counsel in complex internal investigations
Manage department budget and legal/compliance-related outside counsel and consultant activities
30% travel required, potentially including international
Other legal duties, as assigned, to support a growing diverse global company
Qualification
Required
Commercial experience in Life Sciences
At least 10 years of recent relevant legal experience in Life Sciences
Licensed to practice law in one or more US jurisdictions
Experience supporting an active promotional review committee required
Familiarity with Sunshine reporting/aggregate spend rules and process
Excellent oral and written communications skills
Demonstrated courageous leadership and organizational savvy necessary to collaborate effectively with cross-functional teams
Team player and strong collaboration skills
Detail oriented with demonstrated record of problem-solving
Strong ability to influence and present complex information to colleagues and tackle challenging issues beyond the core competencies
Demonstrated success in proactively and independently driving for and delivering results with high impact
A team player who likes to learn, likes to teach, and can self-manage priorities, time, and projects
Company
Compass Consulting
Compass Consulting is a life science staffing and consulting firm serving the needs of biotech, medical device and pharmaceutical companies.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Brett F.
Managing Partner
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