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.

• Manage, evaluate, and complete regulatory projects consistent with company goals • Plan and manage regulatory activities related to assigned projects that span technical areas including clinical, non-clinical, and CMC • Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions • Manage the preparation, writing, assembly, review, and timely submission of regulatory dossiers • Ensure regulatory submissions are maintained in compliance with regulatory requirements • Support and manage preparation of meeting requests and briefing documents • Manage the preparation, review, and submission of all components of regulatory submissions • Participate on project teams and provide expertise on regulatory matters • Develop and maintain current regulatory knowledge and advise management of significant developments • Prepare and maintain regulatory archive • Work with external regulatory consultants/CRO’s as required

Role Description Responsible for providing quality on deliverables at the country level and follows project requirements and applicable country rules, with oversight from the SSU Country Manager. - Works within the forecasted submission/approval timelines and ensures compliance, tracking milestone progress in real time. - If forecasted timelines are not reached, provides clear rationale for delays, assists with contingency plans, and escalates issues as soon as identified. - Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion. - Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keeps training records updated, and ensures timesheet compliance. - Ensures all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements. Responsible for one or more of the following functions at the country level: - Local Submissions Specialist: Follows project direction from the designated country start-up advisor (CSA) and SAM. May serve as a point of contact for the SAM/PM during start-up on allocated projects. Compiles and/or reviews essential document packages for site activation and may also be involved in essential document collection from site. - Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required and under supervision. Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA, and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules, with oversight from the SSU Country Manager. - May act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues. Oversees site activation end-to-end process at country/site level. - Local Site ID and Feasibility Support: Provides support with site selection lead and PM/SAM to ensure appropriate sites are selected for individual studies based on the requirements of the clinical trial. - May be asked to perform: Local Investigator Contract and Budget Negotiator: Supports the SAM to agree on country template contract and budget. Assists in producing site-specific contracts from country template. Under supervision, assists in negotiations of budget and contract with site and via Site Contracts Service Centre and SAM lead with Sponsor until resolution of issues and contract execution. Assists with quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata. Qualifications - Equivalent experience, skills, and/or education will also be considered. Requirements - Tasks, duties, and responsibilities as listed in this job description are not exhaustive. - The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. - The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Benefits - Passionate about developing our people through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. - Committed to building an inclusive culture – where you can authentically be yourself. - Continuously building the company we all want to work for and our customers want to work with.