• The Global Labeling Lead (GLL) serves as a labeling strategy expert for Sobi products within Global Regulatory Affairs (GRA). • The GLL provides both strategic and operational leadership for product labeling, working closely with Regulatory Strategy Leads and other cross-functional stakeholders. • Ensure compliance with relevant Health Authority (HA) regulations, internal procedures, and business objectives. • Support continuous improvement of labeling processes and systems. • Lead the development, implementation, and maintenance of the CCDS, USPI and EU PI for assigned Sobi products throughout the product lifecycle via cross-functional Labeling Working Groups (LWG). • Document and archive LWG decisions and outcomes. • Partner with international Regulatory Affairs (RA) to guide the review and approval process of labels for submission outside of EU and US. • Maintain oversight of labeling compliance, including documentation of labeling content deviations and end-to-end tracking of safety variations.

• Lead the content development, approval, and maintenance of the Company Core Data Sheet (CCDS) and US/EU Product Information (PI). • Manage the review and approval of country labeling for new filings in international markets. • Ensure compliance with relevant Health Authority (HA) regulations, internal procedures, and business objectives. • Support continuous improvement of labeling processes and systems. • Guide LWGs in labeling discussions with HAs, while ensuring management alignment and adherence to labeling governance. • Collaborate closely with internal stakeholders and partner companies, as applicable. • Document and archive LWG decisions and outcomes. • Present new labeling content and major updates to the Executive Labeling Committee for approval. • Partner with international Regulatory Affairs (RA) to guide the review and approval process of labels for submission outside of EU and US. • Maintain oversight of labeling compliance, including documentation of labeling content deviations and end-to-end tracking of safety variations. • Contribute to the development and improvement of labeling processes, including creation and review of process documents. • Support inspections and audits related to labeling activities. • Participate in cross-functional and cross-regional initiatives to strengthen collaboration and increase operational efficiencies.

• Label entities such as material identities, composition specifications, material states, and sources. • Record composition constituents, amounts, and units exactly as written. • Capture stated links such as material-to-composition, material-to-state, claim/example relationships, and coreference. • Preserve span IDs and verbatim text needed for later resolution. • Leave external classification, normalization, equivalence mapping, unit defaulting, and material-family decisions to a separate expert resolution process. • Nice to have/stretch: help develop or evaluate LLM-assisted annotation workflows that improve productivity while preserving human review quality.

• Ensures Post-Hospital Discharge Visits (PHDV) are scheduled within 72 hours of the patients discharge date. • Responsible for scrubbing clinician calendars for the following week ensuring quality visits and optimization of field staff calendars. • Outreach patients with missed visits within the last 3 days to have visit rescheduled. • Completes visit reassignment for clinicians who are not available, including being out of office, transfer to a different role, or have left the Company. • Adheres to scheduling criteria when reassigning the patient to another clinician. • Performs various Pod assignments delegated by direct supervisor on an as needed/requested basis and as time allows. • May be required to provide coverage to other Pods, Regions, and the like based upon business need and may be required to change schedule. • Participates in Pod huddles, which includes Market Manager, MAC, and POD leadership. • Ability to work on site and to adhere to attendance standards.