[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 β’ Program Management: Develop, execute, and continuously improve the corporate compliance program across all business units β’ Risk Assessment & Mitigation: Identify compliance risks and vulnerabilities; conduct audits and reviews; develop corrective action plans; implement preventative strategies β’ 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 β’ Policy Development: Draft, update, and maintain compliance policies, SOPs, and the corporate code of conduct β’ Training & Communication: Lead the development and delivery of compliance training for employees and third parties; foster a culture of compliance through clear, effective communication β’ Internal Investigations: Oversee or assist in investigations of potential compliance violations; document findings and ensure appropriate corrective action β’ 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 β’ Reporting: Prepare and present reports on compliance activities, program effectiveness, and risk metrics to senior leadership and compliance committees β’ Compliance and Administration: Ensure contracts, programs, business initiatives comply with corporate policies, legal requirements, and industry regulations, and maintain organized records β’ Performs other duties, as assigned Skills β’ Bachelor's degree in a relevant field (science, law, business administration, or related discipline) β’ Minimum 5 years experience in the pharmaceutical, healthcare, or biotech industry, with at least 3β5 years in a compliance leadership or managerial role β’ Proven leadership skills and experience managing teams and cross-functional projects β’ Self-starter with the ability to work independently and proactively with minimal supervision β’ Exceptional verbal and written communication skills; demonstrated ability to translate complex regulations into clear policies and effective training β’ Strong analytical and problem-solving abilities, particularly in risk assessment and solution development β’ High ethical standards and integrity, with the ability to build trust and credibility across all stakeholders β’ Must pass a background check β’ Must be legally authorized to work in the United States β’ Master's or JD β’ Pharmaceutical Compliance Certification (Certified Pharmaceutical Industry Professional (CPIP), Certified in Healthcare Compliance (CHC), or Good Manufacturing Practices (cGMP) Certified Professional, etc.) is preferred β’ Experience with federal reimbursement, discounts, rebates, and pricing is a plus Company Overview β’ 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 β’ 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