Compliance Counsel (Fractional)

GALT Pharmaceuticals•Atlanta, GA

9d•Hybrid

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.

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.
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.
Proven leadership skills and experience managing teams and cross-functional projects.
Self-starter with the ability to work independently and proactively with minimal supervision.
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

Master's or JD preferred.
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.
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.