Healthcare Compliance Specialist

Advanced Recruiting Partners; United States; Remote; USD 175,000 - 190,000; Full time

Job summary

A project-based opportunity for a compliance consultant to provide regulatory guidance related to U.S. healthcare professional engagement. This remote role seeks a seasoned professional adept in navigating compliance within the healthcare landscape, supporting both site engagement and clinical operations.

Qualifications

• 7+ years of compliance experience in the pharmaceutical, biotech, or clinical research industry.
• Strong knowledge of U.S. HCP-related regulations.
• Familiarity with clinical trial operations.

Responsibilities

• Serve as a subject matter expert on U.S. HCP compliance.
• Advise on compliance aspects of site identification and selection.
• Support risk assessments and gap analyses related to HCP engagements.

Skills

Regulatory Guidance

Compliance Management

Communication

Documentation Skills

Analytical Skills

Education

JD, MPH, RN, or professional compliance certification (e.g., CHC)

Job description

A project-based opportunity is available for a knowledgeable and experienced Compliance Consultant to provide ad hoc regulatory guidance related to U.S. Healthcare Professional (HCP) engagement. This consultant will support site engagement and clinical operations teams in aligning with all applicable legal, regulatory, and ethical standards in a rapidly evolving healthcare compliance landscape.

This is a remote, flexible consulting role ideal for a seasoned compliance professional with a deep understanding of U.S. healthcare regulations as they apply to the life sciences industry.

Key Responsibilities

• Serve as a subject matter expert (SME) on U.S. HCP compliance, including:
• Sunshine Act / Open Payments reporting
• State-specific transparency laws
• OIG guidance and PhRMA Code
• Advise on compliance aspects of:
• Site identification and selection
• Investigator compensation and fair market value (FMV)
• HCP interactions during trial planning and conduct
• Documentation practices and audit readiness
• Support risk assessments and gap analyses related to HCP engagements
• Review or assist in drafting compliance policies, SOPs, and internal training materials
• Monitor regulatory developments and enforcement trends; provide proactive compliance recommendations
• Remain available on an as-needed basis to support key activities (e.g., site selection, investigator meetings, audit preparation)

Ideal Candidate Profile

• 7+ years of compliance experience in the pharmaceutical, biotech, or clinical research industry
• Strong knowledge of U.S. HCP-related regulations and their application in clinical development settings
• Familiarity with clinical trial operations and interactions with sites, investigators, and CROs
• Proven ability to deliver practical, actionable guidance to cross-functional teams
• Excellent communication, advisory, and documentation skills
• JD, MPH, RN, or professional compliance certification (e.g., CHC) preferred but not required

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science

• Industries

  Staffing and Recruiting

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