Compliance Counsel (Fractional) at GALT Pharmaceuticals

Atlanta, Georgia, United States -

Full Time

Start Date

Immediate

Expiry Date

15 Mar, 26

Salary

0.0

Posted On

15 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Compliance, Risk Assessment, Regulatory Monitoring, Policy Development, Training, Internal Investigations, Stakeholder Collaboration, Reporting, Contract Management, Leadership, Analytical Skills, Problem-Solving, Communication, Ethical Standards, Healthcare Laws, Pharmaceutical Regulations

Industry

Pharmaceutical Manufacturing

Description

Compliance Counsel (Fractional) 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. Professional Qualifications: 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. 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. 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. Employment Requirements: Must pass a background check. Must be legally authorized to work in the United States. What's the Culture like at Galt? We're not your traditional pharmaceutical company! At Galt, our company culture is dynamic, employee-focused, and entrepreneurial. We take pride in offering a career experience that makes you eager to come to work every day. Our environment is built on continuous improvement, fueled by collaboration and diverse perspectives, where challenging problems are solved together! At Galt, you'll find daily opportunities to learn, grow, and inspire those around you. You'll join a team of self-starters, each motivated to make a real impact in every interaction. We value flexibility with work hours and understand the importance of life outside the office, empowering you to achieve your best both professionally and personally!

Responsibilities

As Compliance Counsel, you will design, implement, and oversee Galt's ethics and compliance program. This includes managing compliance risks, conducting audits, and ensuring adherence to laws and regulations.