Galt Pharmaceuticals · 1 day ago
Fractional Compliance Counsel
Atlanta, GA
Full-time
Hybrid
Senior Level
5+ years expGalt Pharmaceuticals is a purpose-driven organization dedicated to improving the quality of life for patients by providing products that address unmet clinical needs. The Compliance Counsel will design, implement, and oversee the ethics and compliance program, ensuring adherence to various laws and regulations while promoting a strong culture of ethical conduct across the organization.
Business DevelopmentHealth CareMedicalPharmaceutical
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
Performs other duties, as assigned
Qualification
Required
Bachelor's degree in a relevant field (science, law, business administration, or related discipline)
Minimum 5 years experience in the pharmaceutical, healthcare, or biotech industry, with at least 3–5 years in a compliance leadership or managerial role
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
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
Preferred
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
Company
Galt Pharmaceuticals
Galt Pharmaceuticals expertize in enhancing the lives of patients, entrepreneurs & communities by transforming the pharmaceutical industry.
11-50 employees
H1B Sponsorship
Galt Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (3)
2023 (1)
2021 (1)
2020 (2)
Funding
Current Stage
Early StageLeadership Team
Barry Patel, Pharm.D
Co-Founder
Anna Claire Smith
Chief Information Officer
Company data provided by crunchbase