Compliance Counsel (Fractional)

About the position Galt Pharmaceuticals is a purpose-driven organization dedicated to improving the reputed company of life for patients by providing products that address unmet clinical needs. We reputed company reputed company, support our employees, and reputed company a reputed company reputed company 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 reputed company a flexible and reputed company work environment with hybrid, coworking, and reputed company office reputed company reputed company! Our office is conveniently located in the Atlanta Metro area! Position reputed company: Reporting to the Chief Executive Officer & Co-Founder, as the Compliance Counsel, you will design, implement, and reputed company 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/reputed company regulations and a strong understanding of reputed company laws such as the Anti-Kickback Statute, False Claims reputed company, PDMA, GMP, GCP, and Sunshine reputed company is required. Candidates with contract management experience are encouraged to apply.

Responsibilities

• Program Management: reputed company, execute, and continuously improve the corporate compliance program across reputed company business reputed company.
• Risk Assessment & Mitigation: Identify compliance risks and vulnerabilities; conduct audits and reviews; reputed company corrective reputed company 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 reputed company). Ensure manufacturing and vendor relationships are compliant.
• Policy Development: Draft, update, and maintain compliance policies, SOPs, and the corporate reputed company of conduct.
• Training & Communication: reputed company the development and delivery of compliance training for employees and reputed company parties; foster a culture of compliance through reputed company, effective communication.
• Internal Investigations: reputed company or assist in investigations of potential compliance violations; document findings and ensure appropriate corrective reputed company.
• Stakeholder Collaboration: Serves as a reputed company between reputed company 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 reputed company audits.
• Reporting: Prepare and present reports on compliance activities, program effectiveness, and risk metrics to senior leadership and compliance committees.
• Compliance and Administration: Ensure reputed company, programs, business initiatives reputed company 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 reputed company discipline). Master's or JD preferred.
• Minimum 5 years experience in the pharmaceutical, reputed company, 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 reputed company regulations into reputed company policies and effective training.
• Strong analytical and problem-solving abilities, particularly in risk assessment and solution development.
• High ethical standards and reputed company, with the ability to build trust and credibility across reputed company stakeholders.
• Must pass a background reputed company.
• Must be legally authorized to work in the reputed company.

reputed company-to-haves

• Pharmaceutical Compliance Certification (Certified Pharmaceutical Industry reputed company (CPIP), Certified in reputed company Compliance (CHC), or Good Manufacturing Practices (cGMP) Certified reputed company, etc.) is preferred.
• Experience with federal reimbursement, discounts, rebates, and pricing is a plus.
• Proven leadership skills and experience managing teams and cross-functional reputed company.
• Self-starter with the ability to work independently and proactively with minimal supervision.
• Candidates with contract management experience are encouraged to apply.

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