Sobi - Swedish Orphan Biovitrum AB (publ)

Compliance

• The Global GxP Quality Systems Head is accountable for working collaboratively across the organization (at global and local level) to develop and implement of an enterprise-wide Quality and Compliance strategy covering end-to-end regulated processes conducted by Sobi functions, Affiliates, service providers and partners to assure adherence to global health authority requirements across the product lifecycle.
• Leading Global GxP Compliance & Quality Systems team
• Responsible for advancing a Quality &Compliance Excellence mind set and has a unique opportunity to lead transformational change to a culture of excellence and working across the Global Quality organization to streamline and simplify by taking an end-to-end integrated approach to quality and compliance across the product lifecycle
• Responsible for the effectiveness and sustainability of Global Sobi Quality Management System at global and local level
• Responsible to oversee the quality system and ensure compliance with current GxP and regulatory requirements
• Responsible to establish and maintain budget and timelines as well as supervise the implementation and maintenance of quality relevant processes
• Responsible to provide leadership and strategic direction to teams working within GxP relevant activities to ensure adherence to the principles and processes of the quality strategy and take actions where needed to ensure company wide compliance
• Responsible to oversee of quality relevant processes, and in conjunction with the Global Process Owners identify areas of improvement and implement steps to improve them with a continuous focus on improving strategies and tools
• Responsible for the development, implementation and sustainability of risk management process for timely identification and reporting of risks to maintain a concept of Quality Risk Management
• Accountable for the definition and approval of Annual Audit Programs and preparation, conduction/host and follow up of internal audits and regulatory inspections
• Responsible to provide strategic direction and report performance of the quality system and related procedures to Sobi Senior Leaders Officer on a regular basis and initiate preventive and corrective actions to avoid recurrence of deviations/non-conformances

Head of Global GxP Quality System and Compliance

• Establishing, maintaining, and continuously developing the company's pharmacovigilance system
• Ensuring compliance with regulatory requirements for medical devices
• Managing and contributing to all pharmacovigilance activities
• Supporting inspections by national regulatory authorities
• Creating and maintaining PV SOPs and templates
• Performing reconciliation of AE/SAE cases
• Documenting and managing PV-related deviations and CAPAs
• Acting as the person responsible for medical device safety
• Monitoring regulatory changes in medical device legislation
• Collaborating with external notified bodies and authorities

Manager, Pharmacovigilance and Medical Device Regulations

• Will act as a business partner to support the affiliate to achieve its strategic business objectives with integrity and high ethical standards
• Develop, implement, and continuously improve the company’s Compliance Program
• Be the first point of contact for DACH affiliate compliance questions related
• Act as Affiliate Subject Matter Expert (SME) for Compliance in the Sobi Global Compliance Network
• Liaise with the Regional Compliance Office, or with the Global Compliance Department
• Identify, assess, and communicate affiliate risks, including compliance Register, remediation action plan.
• Provide guidance and partner with business stakeholders on risk management
• Be the first point of contact in relation to any correspondence from the FSA codes
• Keep abreast with relevant local legislation and trade association practice, take relevant steps to ensure compliance
• Where applicable, represent Sobi in local trade association compliance forum
• Ensure the affiliate policies, procedures and standards are up to date and aligned with global standards and where necessary CAPA (corrective action & preventive action) are developed and implemented
• Develop a local training curriculum, and deliver regular compliance training and awareness
• Perform monitoring activities, share the results with business management and Regional/Corporate Compliance Office and ensure mitigation plans are in place and followed through
• Support or drive local compliance investigations and assure the right mitigation action of all observed incidents
• Ensure prompt communication of potential compliance issues to the GM and Regional Compliance Office
• Support and/or drive local implementation of global compliance projects
• Provide regular compliance updates to the General Manager and local management team
• Ensure audit readiness (e.g., proper record keeping of meeting minutes, decision points, training records, etc.)
• Be the first point of contact for affiliate questions and queries related to personal data protection (GDPR)

Compliance Manager

Account Manager

• Acts as the primary customer contact for sales demand creation by executing marketing strategy and promoting Sobi products
• Provides current and comprehensive clinical knowledge of Sobi’s products and effectively communicates the on-label clinical benefits of the products
• Expected to achieve territory sales by executing Plan of Action (POA) marketing strategies
• Delivers branded sales messages to customers
• Represents 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
• Weekly analysis of territory sales data to help prioritize physician targeting and ensure accurate reporting of physicians
• Prepares territory budget plans for customer contacts, local symposia, and other miscellaneous external expenditures
• Assists in the identification and resolution of issues and opportunities and communicates proactively to sales and marketing management
• Reports all adverse events to Sobi’s Drug Safety department as appropriate per required guidelines
• Performs all administrative functions require of the position, including reporting call activity and customer information into the appropriate call reporting system in a timely manner, submitting expenses, etc.
• Team Player able to work cross functionally in a matrix environment

Clinical Account Manager – Senior Clinical Account Manager

Manager

• Support the development and execution of scientific communications and medical activities for assigned assets
• Work closely with the Global Scientific Affairs and Medical Affairs leads to ensure high-quality delivery of congress materials, medical education and training initiatives
• Focus on operational execution, project coordination, and content support, ensuring timely and compliant implementation of scientific strategies
• Assist in drafting, reviewing, and formatting scientific materials
• Maintain trackers and ensure milestone adherence
• Coordinate congress deliverables
• Liaise with internal stakeholders and agencies for content development
• Ensure alignment of materials with scientific and compliance requirement
• Support development and rollout of internal and external training materials
• Coordinate logistics for training activities (content, speakers, timelines)
• Maintain training materials repository and updates
• Act as a key operational interface with Medical Affairs, Regulatory & Compliance, Clinical and Market Access, Affiliate medical teams
• Track deliverables and ensure alignment across stakeholders
• Prepare internal updates, slide decks, and reporting materials
• Maintain project plans, trackers, and communication timelines
• Identify risks or delays and proactively escalate
• Support implementation of digital/multichannel initiatives
• Ensure documentation is compliant and audit-ready
• Conduct literature searches and summarize key scientific insights
• Monitor external developments relevant to assigned assets
• Support preparation of internal scientific briefings
• Support the scientific communications strategy for assigned assets
• Work with the cross-functional teams and external agencies to define appropriate medical communication solutions to support product/disease area strategy implementation across geographies
• Support, develop and execute key training needs of the affiliates
• Contribute to innovative digital/multichannel approaches for the dissemination of medical materials
• Stay abreast of internal and external developments relevant to the assigned assets

Manager, Global Scientific Affairs

Medical Director

• Lead medical strategy and external engagement for the VEXAS disease area
• Serve as the lead medical voice for VEXAS
• Drive the US medical strategy and partner closely with Field Medical to engage and educate healthcare providers (HCPs), medical organizations, payers, and patient advocacy groups
• Lead planning and execution of advisory boards and educational activities
• Generate and share medical insights with internal partners
• Build strong collaborative relationships across Market Access, Medical Information, Clinical Development, Sales, and Marketing
• Contribute to evidence generation projects, real-world evidence studies, and publications supporting the VEXAS disease area
• Support launch readiness through disease education and evidence generation planning

Hematology Medical Director – VEXAS

• The Clinical Account Manager (CAM) acts as the primary customer contact for sales demand creation by executing marketing strategy and promoting Sobi products as lead by the Regional Sales Director.
• In this strategic role, the CAM provides current and comprehensive clinical knowledge of Sobi’s products and effectively communicates the on-label clinical benefits of the products.
• As a sales leader, the CAM is expected to achieve territory sales by executing Plan of Action (POA) marketing strategies, which includes delivering branded sales messages to customers, representing Sobi at local meetings, and 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 and 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 and weekly analysis of territory sales data to help prioritize physician targeting and ensure accurate reporting of physicians.
• Prepares territory budget plans for customer contacts, local symposia, and other miscellaneous external expenditures.
• Assists in the identification and resolution of issues and opportunities and communicates proactively to sales and marketing management.
• Reports all adverse events to Sobi’s Drug Safety department as appropriate per required guidelines.
• Performs all administrative functions require of the position, including reporting call activity and customer information into the appropriate call reporting system in a timely manner, submitting expenses, etc.

Senior Clinical Account Manager

• Deliver Sales Targets & Territory Performance
• Develop and execute robust account plans to secure and exceed territory sales targets.
• Continuously adjust plans based on customer insights, adoption ladder, competition, and market dynamics.
• Analyze sales performance, activity metrics, and spending to ensure efficient, high‑impact territory management.
• Contribute to accurate forecasting by providing timely, data‑based insights.
• Market Knowledge & Opportunity Identification
• Acquire in‑depth understanding of the therapeutic landscape, clinical stakeholders, treatment pathways, payer dynamics, and competition.
• Routinely gather and interpret insights from customer interactions, Veeva usage, and available market data.
• Identify, evaluate, and prioritize business opportunities; collaborate with the cross‑functional team to decide on optimal tactics.
• Customer Engagement & Relationship Management
• Build and maintain strong relationships with key opinion leaders, clinical specialists, pharmacists, and other stakeholders.
• Conduct all promotional and non‑promotional interactions in full compliance with local regulations, industry codes, and Sobi policies.

Key Account Manager – Metabolic Diseases

Sales

• Deliver regional sales, activity, and business objectives aligned with national goals.
• Lead, coach, and develop a team of Key Account Managers.
• Monitor individual and team performance through clear objectives, KPIs, and development plans.
• Foster a culture of high performance, accountability, and collaboration.
• Support recruitment, onboarding, training, and talent development initiatives.
• Ensure effective execution of regional commercial plans and promotional activities.
• Conduct regular field coaching visits to strengthen selling skills, account management, and customer engagement.
• Monitor territory performance through CRM, dashboards, and business analytics.
• Identify opportunities and implement corrective actions to maximize business outcomes.
• Drive excellence in account planning, targeting, segmentation, and omnichannel execution.
• Develop strong relationships with key healthcare professionals, treatment centres, and relevant stakeholders within the region.
• Support strategic customer engagements and help remove barriers to patient access.
• Ensure customer insights are systematically captured and translated into action.
• Promote a consistent scientific, patient-centric, and value-based dialogue.
• Collaborate closely with Marketing, Medical Affairs, PACE, Commercial Excellence and other teams.
• Provide market insights, competitive intelligence, and customer feedback to support business planning.
• Contribute to national business reviews, forecasting cycles, and launch execution initiatives.

Regional Sales Manager, Metabolic Diseases

General

• 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

Global Labelling Lead

Marketing

• 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

• 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

• 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.

• 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

• 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