Compliance Counsel (Fractional)
About the position Galt Pharmaceuticals is a purpose-driven organization dedicated to improving the quality of life for patients by providing products that address unmet clinical needs. We empower entrepreneurs, support our employees, and make a positive impact in the communities we serve. We are seeking a highly motivated, self-starting Compliance Counsel of Compliance to join our growing team! This is a part-time (18-20 hrs. per week) position. We provide a flexible and collaborative work environment with hybrid, coworking, and flex office space options! Our office is conveniently located in the Atlanta Metro area! Position Overview: Reporting to the Chief Executive Officer & Co-Founder, as the Compliance Counsel, you will design, implement, and oversee Galt's ethics and compliance program, ensuring adherence to a dynamic landscape of federal, state, and international laws and regulations. This leadership role is critical to mitigating legal and financial risks, preventing misconduct, and promoting a strong culture of ethical conduct across the organization. In-depth knowledge of FDA, OIG, EMA, DOJ, Medicare/Medicaid regulations and a strong understanding of healthcare laws such as the Anti-Kickback Statute, False Claims Act, PDMA, GMP, GCP, and Sunshine Act is required. Candidates with contract management experience are encouraged to apply. Responsibilities • Program Management: Develop, execute, and continuously improve the corporate compliance program across all business units. • Risk Assessment & Mitigation: Identify compliance risks and vulnerabilities; conduct audits and reviews; develop corrective action plans; implement preventative strategies. • Regulatory Monitoring: Stay abreast of evolving laws, regulations, and industry trends from regulatory bodies (FDA, EMA, DOJ, OIG, etc.) and industry codes (e.g., PhRMA Code). Ensure manufacturing and vendor relationships are compliant. • Policy Development: Draft, update, and maintain compliance policies, SOPs, and the corporate code of conduct. • Training & Communication: Lead the development and delivery of compliance training for employees and third parties; foster a culture of compliance through clear, effective communication. • Internal Investigations: Oversee or assist in investigations of potential compliance violations; document findings and ensure appropriate corrective action. • Stakeholder Collaboration: Serves as a liaison between outside counsel and/or consulting services; serves as a strategic partner and compliance advisor to senior management, legal counsel, medical and regulatory affairs, and cross-functional teams; represent Galt during regulatory inspections and client audits. • Reporting: Prepare and present reports on compliance activities, program effectiveness, and risk metrics to senior leadership and compliance committees. • Compliance and Administration: Ensure contracts, programs, business initiatives comply with corporate policies, legal requirements, and industry regulations, and maintain organized records. • Manages personnel, as required. • Performs other duties, as assigned. Requirements • Bachelor's degree in a relevant field (science, law, business administration, or related discipline). Master's or JD preferred. • Minimum 5 years experience in the pharmaceutical, healthcare, or biotech industry, with at least 3–5 years in a compliance leadership or managerial role. • Exceptional verbal and written communication skills; demonstrated ability to translate complex regulations into clear policies and effective training. • Strong analytical and problem-solving abilities, particularly in risk assessment and solution development. • High ethical standards and integrity, with the ability to build trust and credibility across all stakeholders. • Must pass a background check. • Must be legally authorized to work in the United States. Nice-to-haves • Pharmaceutical Compliance Certification (Certified Pharmaceutical Industry Professional (CPIP), Certified in Healthcare Compliance (CHC), or Good Manufacturing Practices (cGMP) Certified Professional, etc.) is preferred. • Experience with federal reimbursement, discounts, rebates, and pricing is a plus. • Proven leadership skills and experience managing teams and cross-functional projects. • Self-starter with the ability to work independently and proactively with minimal supervision. • Candidates with contract management experience are encouraged to apply. Apply tot his job