• Liaise with SAR colleagues to drive plan, organize, compile, progress, track, and submit regulatory submissions on a timely basis and with a consistently high level of quality. • May act as a contact point for translation review of submission documents such as applications, synopses, ICFs, labels, etc. • Maintain country-specific patient information sheet and consent form customization text. • Maintain country-specific drug labeling information and Country Intelligence Pages. • Review and make recommendations on all relevant documentation e.g. labels, patient information sheets, diary cards etc. to comply with ICH GCP & country-specific requirements.

• Ensures compliance with federal and state laws, regulations, and rules governing healthcare entities • Identifies risk areas, prepares audit tools, conducts audits, and provides analysis and recommendations to executive leadership • Conducts audits and provides support for other internal or external auditors • Investigates and resolves compliance issues related to the healthcare environment • Evaluates regulatory agency reports and formulates responses and corrective actions • Maintains logs, indexes, files, computer databases, and other records pertaining to compliance and risk • Creates logs and systems for entering and tracking compliance guidelines • Confers with administrative staff regarding compliance risk areas and final reports • Develops strategies and leads compliance related committees/work groups • Implements compliance procedures • Responsible for ensuring compliance with governmental requirements

Role Description The Trade Administrator will support team members within the Global Trade Management division to gather, prep, and data enter documents; assist in mailings, and filing; and other tasks associated with supporting trade compliance on behalf of our clients. The Trade Administrator can be involved in many aspects of GTM processes including analyzing client data/documents. Key Duties & Responsibilities - Data entry. - Performing validation/quality checks on data entry. - Printing, sorting, and/or filing/storing documentation. - Preparing packages for shipments to customs. - Assisting with preparation of client materials. - Maintaining client information, documentation, and desk procedures. - Preparing documents for currency conversions and value adjustments. - Assisting with ongoing project tasks. - Perform other related duties as assigned by management. - Adhere to established policies and procedures. Qualifications - Ability and desire to learn on the job. - Proficient in MS Office applications, specifically Excel. - Detail oriented and capable of handling large amounts of data. - Ability to work under tight deadlines. - Excellent organizational skills. - Self-starting with great time management. - Strong communication skills, both written and verbal. - Demonstrated positive, professional attitude and commitment to personal, team, and company goals. Work Experience – Minimum Required - Required: Associates Degree or post-secondary education in Business. - Preferred: High School/GED or equivalent. Competencies - Accountability. - Agility. - Customer First Focus. - Inclusion and Collaboration. - Leading and Developing. Benefits En Livingston, estamos comprometidos a fomentar un ambiente flexible y orientado al crecimiento donde puedas prosperar. Nuestra cultura se basa en el respeto, el reconocimiento y la colaboración, y empoderamos a nuestro equipo con experiencia confiable, oportunidades de aprendizaje continuo y apoyo a largo plazo. Ofrecemos una compensación competitiva, beneficios integrales y una filosofía salarial transparente, alineada con los datos del mercado y los factores relacionados con el puesto.

• Assist the System 340B Manager with daily 340B program operations and compliance activities. • Lead and support 340B-related projects as needed, while collaborating with internal and external stakeholders to enhance program efficiency. • Maintain up-to-date policies and procedures on 340B purchasing processes. • Develop systems and processes to limit program liabilities and provide proper audits to identify risk. • Review 340B Program policies and procedures on an ongoing basis and offer contributions to ensure compliance. • Develop proper 340B quality assurance training for employees as appropriate.