[Remote] Fractional Compliance Counsel *Remote*

Note: The job is a remote job and is open to candidates in USA. Galt Pharmaceuticals is a purpose-driven organization dedicated to improving the quality of life for patients. They are seeking a highly motivated Compliance Counsel to design, implement, and oversee the ethics and compliance program, ensuring adherence to various laws and regulations.

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

Skills

• 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
• Master's or JD
• 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 Overview

• Galt Pharmaceuticals expertize in enhancing the lives of patients, entrepreneurs & communities by transforming the pharmaceutical industry. It was founded in 2016, and is headquartered in Atlanta, Georgia, USA, with a workforce of 11-50 employees. Its website is https://galtrx.com.

Company H1B Sponsorship

• Galt Pharmaceuticals has a track record of offering H1B sponsorships, with 3 in 2024, 1 in 2023, 1 in 2021, 2 in 2020. Please note that this does not guarantee sponsorship for this specific role.

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