Job Description
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 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. Apply tot his job