Sobi - Swedish Orphan Biovitrum AB (publ)

General

• The Global Labeling Lead (GLL) serves as a labeling strategy expert for Sobi products within Global Regulatory Affairs (GRA).
• Provide both strategic and operational leadership for product labeling, working closely with Regulatory Strategy Leads and other cross-functional stakeholders.
• 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.
• 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).
• 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.

Global Labelling Lead

Marketing

• Provide commercial support for brand marketing strategy and tactical execution across the US hematology portfolio.
• Support and execute the commercial marketing plan for key HCP segments across multiple channels, including media, digital, print, and omnichannel.
• Ensure all tactics align with brand strategy and drive achievement of defined KPIs and goals.
• Apply strong project management capabilities to ensure deliverables are completed on time, within budget, and aligned with business objectives.
• Measure and assess the impact of marketing initiatives against defined goals and optimize plans accordingly.
• Collaborate with MLR reviewers to ensure all brand materials meet medical, legal, and regulatory requirements.

Hematology Marketing Manager

• 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.

• Provide commercial support for brand marketing strategy and tactical execution across the US hematology portfolio
• Support and execute the commercial marketing plan for key HCP segments across multiple channels
• Apply strong project management capabilities to ensure deliverables are completed on time and within budget
• Measure and assess the impact of marketing initiatives against defined goals and optimize plans accordingly
• Collaborate with MLR reviewers for medical, legal, and regulatory review of brand materials
• Manage external vendors and agencies to ensure delivery of work consistent with brand strategy

• 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.

Director

• Provide strategic leadership and operational oversight to ensure the successful, on-time, and high-quality launch of Sobi's launches in future pipeline products
• Establish and lead Sobi's Launch Excellence framework, integrating cross-functional planning, governance, and performance measurement
• Serve as the central orchestrator of launch readiness, ensuring alignment across Commercial, Medical Affairs, Market Access, Regulatory Affairs, Supply Chain, and other key functions
• Embed a culture of operational excellence, accountability, and continuous improvement
• Leverage data-driven insights and market intelligence to optimize launch performance and patient impact in rare disease markets
• Define and lead the North America Launch Excellence strategy
• Establish and evolve a repeatable launch framework that drives consistency, accountability, and excellence across all product launches
• Oversee the end-to-end launch planning and execution process, setting clear milestones, timelines, and deliverables
• Partner with global and regional leadership to ensure launch readiness governance, including stage gates, KPIs, and risk management processes
• Lead a high-performing, cross-functional launch team including representatives from Marketing, Sales, Medical Affairs, Market Access, Customer Experience, Insights and Operations, Supply Chain, and Regulatory Affairs

Senior Director, Launch Excellence

Compliance

• Support monitoring activities (data collection)
• Support monitoring CAPAs
• Support transfer of value reporting
• Manage annual FMV updates
• Preparation, communication and monitoring of Data Privacy Notice (DPN)
• Support compliance trainings (systems)
• Support with systems by being a super user (e.g. Veeva, SOOS)
• Supporting Compliance Director and Senior Compliance Manager with various tasks

Junior Compliance Specialist, CEE

Account Manager

• Execute marketing strategy and promote Sobi products as lead by the Regional Sales Director.
• Provide current and comprehensive clinical knowledge of Sobi’s products and effectively communicate the on-label clinical benefits of the products.
• Achieve territory sales by executing Plan of Action (POA) marketing strategies.
• Deliver branded sales messages to customers, representing Sobi at local meetings.
• Achieving or exceeding sales targets.
• Responsible for representing Sobi’s products and services to a defined customer base.
• Generating and growing sales and consistently achieving or exceeding sales goals within a specific geographic area.
• Actively promotes the appropriate use of Sobi products to healthcare professionals in accordance with all Corporate, PhRMA, and OIG guidelines.
• Develops and implements a territory business plan to meet customer needs and achieve sales goals.
• Prepare territory budget plans for customer contacts, local symposia, and other miscellaneous external expenditures.
• Reports all adverse events to Sobi’s Drug Safety department as appropriate per required guidelines.

Sobi - Swedish Orphan Biovitrum AB (publ)

Global Labelling Lead

Hematology Marketing Manager

Global Labelling Lead

Hematology Marketing Manager

Global Labelling Lead

Senior Director, Launch Excellence

Junior Compliance Specialist, CEE

Clinical Account Manager/Senior Clinical Account Manager

Junior Compliance Specialist, CEE

Junior Compliance Specialist, CEE

Junior Compliance Specialist, CEE

Junior Compliance Specialist, CEE+

Junior Compliance Specialist, CEE

Junior Compliance Specialist, CEE

Junior Compliance Specialist