[Remote] Fractional Compliance Counsel *Remote*

Remote Full-time
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 3–5 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
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