Sobi - Swedish Orphan Biovitrum AB
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Headquartered in Stockholm, Sweden, Swedish Orphan Biovitrum AB is an international biopharmaceutical company dedicated to transforming the lives of individuals with rare and debil
233 Jobs
Medical Science Manager – Metabolic Disorder
Sobi - Swedish Orphan Biovitrum ABHeadquartered in Stockholm, Sweden, Swedish Orphan Biovitrum AB is an international biopharmaceutical company dedicated to transforming the lives of individuals
• Build and nurture strong collaborations with KOLs, scientific experts, and medical stakeholders. • Deliver impactful scientific communication and education, both externally and internally. • Create and execute stakeholder engagement plans to support patient access. • Organise and lead scientific advisory boards in partnership with HQ. • Represent Sobi at key national, regional, and global congresses. • Provide medical input for local tactics, regional plans, and business development opportunities. • Stay at the forefront of therapeutic and regulatory trends, ensuring scientific excellence in all activities.
Medical Science Manager – Metabolic Disorder
Sobi - Swedish Orphan Biovitrum ABHeadquartered in Stockholm, Sweden, Swedish Orphan Biovitrum AB is an international biopharmaceutical company dedicated to transforming the lives of individuals
• Build and nurture strong collaborations with KOLs, scientific experts, and medical stakeholders. • Deliver impactful scientific communication and education, both externally and internally. • Create and execute stakeholder engagement plans to support patient access. • Organise and lead scientific advisory boards in partnership with HQ. • Represent Sobi at key national, regional, and global congresses. • Provide medical input for local tactics, regional plans, and business development opportunities. • Stay at the forefront of therapeutic and regulatory trends, ensuring scientific excellence in all activities.
Global Labelling Lead
Sobi - Swedish Orphan Biovitrum ABHeadquartered in Stockholm, Sweden, Swedish Orphan Biovitrum AB is an international biopharmaceutical company dedicated to transforming the lives of individuals
• The Global Labeling Lead (GLL) serves as a labeling strategy expert for Sobi products within Global Regulatory Affairs (GRA) • Provides both strategic and operational leadership for product labeling, working closely with Regulatory Strategy Leads and other cross-functional stakeholders • Ensures that product labeling reflects scientific integrity, regulatory compliance, and patient focus across global markets • 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 Labeling Working Groups (LWG) in labeling discussions with HAs, while ensuring management alignment and adherence to labeling governance • 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
Hematology Marketing Manager
Sobi - Swedish Orphan Biovitrum ABHeadquartered in Stockholm, Sweden, Swedish Orphan Biovitrum AB is an international biopharmaceutical company dedicated to transforming the lives of individuals
• The US Hematology Marketing Manager provides 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 • 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 and aligned with business objectives • Measure and assess the impact of marketing initiatives against defined goals and optimize plans accordingly • Serve as the primary point of contact for marketing asset inventory management and fulfillment • Collaborate with MLR reviewers to ensure all brand materials meet medical, legal, and regulatory requirements • Manage external vendors and agencies to ensure delivery of work consistent with brand strategy
Hematology Marketing Manager
Sobi - Swedish Orphan Biovitrum ABHeadquartered in Stockholm, Sweden, Swedish Orphan Biovitrum AB is an international biopharmaceutical company dedicated to transforming the lives of individuals
• Provides 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 • Serve as the primary point of contact for marketing asset inventory management and fulfillment • Collaborate with MLR reviewers to ensure all brand materials meet medical, legal, and regulatory requirements • Manage external vendors and agencies to ensure delivery of work consistent with brand strategy
Global Labelling Lead
Sobi - Swedish Orphan Biovitrum ABHeadquartered in Stockholm, Sweden, Swedish Orphan Biovitrum AB is an international biopharmaceutical company dedicated to transforming the lives of individuals
• Serve 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. • Ensure that product labeling reflects scientific integrity, regulatory compliance, and patient focus across global markets. • 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 Labeling Working Groups (LWG) in labeling discussions with HAs, 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.
Hematology Marketing Manager
Sobi - Swedish Orphan Biovitrum ABHeadquartered in Stockholm, Sweden, Swedish Orphan Biovitrum AB is an international biopharmaceutical company dedicated to transforming the lives of individuals
• Provide commercial support for brand marketing strategy and tactical execution across the US hematology portfolio • Collaborate with internal stakeholders to drive strategic alignment, execution excellence, and measurable performance • Support and execute the commercial marketing plan for key HCP segments across multiple channels • 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 and within budget • Measure and assess the impact of marketing initiatives against defined goals and optimize plans accordingly • Manage external vendors and agencies to ensure delivery of work consistent with brand strategy
Global Labelling Lead
Sobi - Swedish Orphan Biovitrum ABHeadquartered in Stockholm, Sweden, Swedish Orphan Biovitrum AB is an international biopharmaceutical company dedicated to transforming the lives of individuals
• The Global Labeling Lead (GLL) serves as a labeling strategy expert for Sobi products within Global Regulatory Affairs (GRA) • Provides both strategic and operational leadership for product labeling, working closely with Regulatory Strategy Leads and other cross-functional stakeholders • Ensures that product labeling reflects scientific integrity, regulatory compliance, and patient focus across global markets • 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 • 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
Sobi - Swedish Orphan Biovitrum ABHeadquartered in Stockholm, Sweden, Swedish Orphan Biovitrum AB is an international biopharmaceutical company dedicated to transforming the lives of individuals
• 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.
Hematology Marketing Manager
Sobi - Swedish Orphan Biovitrum ABHeadquartered in Stockholm, Sweden, Swedish Orphan Biovitrum AB is an international biopharmaceutical company dedicated to transforming the lives of individuals
• 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.
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