Sobi - Swedish Orphan Biovitrum AB (publ)

Manager

• Oversee the ISS review and approval process, including proposal validation, coordination of reviews, and communication of decisions to stakeholders
• Manage the MAP/PTA review and approval process, including coordination of case reviews, decision documentation, and communication with relevant parties
• Serve as the global point of contact for ISS and MAP management for designated products, working with cross-functional internal and external stakeholders
• Maintain comprehensive databases for ISS and MAP/PTA, tracking proposals, studies, and decisions with relevant documentation
• Facilitate contract development and negotiation between sponsors/requestors and Sobi, collaborating with legal, MPL, and other functions as required
• Support supply chain set-up in conjunction with Affiliate teams and Sobi Supply Chain for both ISS and MAP/PTA programs
• Provide regular status updates on ISS and MAP/PTA programs to responsible teams and leadership
• Monitor milestone payments and report ISS budget to budget owners
• Coordinate with vendors on the set-up and management of MAP and PTA programs as needed

Medical Excellence Manager

Customer Success Manager

• Responsible for delivering seamless and engaging experiences for healthcare professionals (HCPs) across all platforms
• Accelerating brand engagement and topline growth
• Work in close collaboration with global cross functional and affiliates teams
• Develop impactful customer journeys, high quality content and engaging affiliates across channels
• Experience in rep triggered and blast emails, webinar platforms, and HCPs portals

Global Omnichannel Customer Engagement Lead

• Develop omnichannel plans, and advise on approach to campaign execution across markets
• Collaborate with cross functional teams (both commercial and non-commercial) to create personalized journeys based on customer preference data and brand objectives with simple and impactful KPIs
• Build digital content ensuring consistent messaging, visuals and positioning across all channels and platforms
• Enhance and evolve Sobi’s HCP portal (SobiPro), incorporating industry best practices
• Set clear KPI’s and monitor campaigns to track performance and suggest enhancements
• Proactively assess future trends in customer engagement to accelerate our capability and provide Sobi with a competitive edge

• Develop omnichannel plans, and advise on approach to campaign execution across markets
• Develop and roll out best practice guidance to affiliates to deploy and execute campaigns effectively driving impact for the brands
• Collaborate with cross functional teams (both commercial and non-commercial) to create personalized journeys based on customer preference data and brand objectives with simple and impactful KPIs
• Develop omnichannel guidance and governance through playbooks, training and resources to support the business to execute in a consistent and impactful manner
• Be seen as an SME championing strong customer engagement though omnichannel strategies
• Build digital content ensuring consistent messaging, visuals and positioning across all channels and platforms
• Support brand teams with their communication and messaging goals across non personal channels
• Enhance and evolve Sobi’s HCP portal (SobiPro), incorporating industry best practices
• Co-create channel capability with global and affiliate colleagues, providing strategic guidance
• Set clear KPI’s and monitor campaigns to track performance and suggest enhancements
• Support line manager to develop omnichannel and digital roadmap for the region(s)
• Proactively assess future trends in customer engagement to accelerate our capability and provide Sobi with a competitive edge
• Operate with high ethical standards in line with the Sobi corporate values and SOPs by ensuring ongoing completion of all required initial and ongoing training in local regulations and policies, and adherence to those regulations and policies

• Managing Investigator Sponsored Studies (ISS), Managed Access Programs (MAP) and Post Trial Access (PTA) Programs
• Oversee the ISS review and approval process
• Manage the MAP/PTA review and approval process
• Serve as the global point of contact for ISS and MAP management
• Maintain comprehensive databases for ISS and MAP/PTA
• Facilitate contract development and negotiation
• Support supply chain set-up
• Provide regular status updates on ISS and MAP/PTA programs
• Monitor milestone payments and report ISS budget

Compliance

• Develop global regulatory CMC strategies to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which include CMC information
• Write and compile CMC sections of regulatory submissions including clinical trial applications and variations/supplements as well as registration submissions worldwide
• Lead team of SMEs through extensive knowledge of eCTD requirements for Quality modules with respect to marketing authorization, post approval changes and clinical trial applications globally
• Review data provided to support dossier preparation; identify gaps and risks and work with stakeholders to understand regulatory impact of the risks identified to aid with mitigation and informed decision making
• Manage answers to questions from the Health Authorities in a timely and effective manner to ensure early approval
• Interact and negotiate with Health Authorities on CMC issues
• Develop and maintain project plans and schedules for CMC submissions
• Evaluate proposed manufacturing changes for global impact assessments and provide regulatory strategies that support change implementation
• Provide guidance on ICH, FDA, and EU CMC guidelines
• Develop and maintain strong relationships with internal functional groups, contract manufacturing organizations and other relevant partners to ensure alignment of regulatory CMC strategies and successfully accomplish regulatory objectives
• Represent the Regulatory Affairs CMC function on assigned cross-functional project teams
• Ensure all CMC dossiers and relevant regulatory information are stored in Veeva according to Sobi’s guidelines

Global Regulatory CMC Lead

• Oversee the ISS review and approval process, including proposal validation, coordination of reviews, and communication of decisions to stakeholders.
• Manage the MAP/PTA review and approval process, including coordination of case reviews, decision documentation, and communication with relevant parties.
• Serve as the global point of contact for ISS and MAP management for designated products, working with cross-functional internal and external stakeholders.
• Maintain comprehensive databases for ISS and MAP/PTA, tracking proposals, studies, and decisions with relevant documentation.
• Facilitate contract development and negotiation between sponsors/requestors and Sobi, collaborating with legal, MPL, and other functions as required.
• Support supply chain set-up in conjunction with Affiliate teams and Sobi Supply Chain for both ISS and MAP/PTA programs.
• Provide regular status updates on ISS and MAP/PTA programs to responsible teams and leadership.
• Monitor milestone payments and report ISS budget to budget owners.
• Coordinate with vendors on the set-up and management of MAP and PTA programs as needed.

Analyst

• Data-driven support for commercial decision-making in rare disease markets
• Regular sales reporting and performance analytics for General Manager and Sales Leadership
• Development and maintenance of interactive executive dashboards (Power BI or similar) with KPIs on sales performance, territory potential, and inventory
• Analysis of patient, physician, and market data to identify trends, growth opportunities, and optimization levers
• Monitoring and reporting of rare-disease-specific metrics (patient identification, HCP engagement, Centers of Excellence performance)
• Execution of detailed territory analyses based on prevalence data, treatment centers, and HCP networks
• Identification of high-value treatment centers and key physicians for targeted engagement
• Creation of cycle plans and territory dossiers including patient flow maps, diagnosis rates, and market access barriers
• Support of strategic territory optimization considering geographically dispersed patient populations
• Development and maintenance of demand forecasting models based on epidemiological data and market launch timelines
• Optimization of inventory management aligned with specialty pharmacy distribution and patient clusters
• Monitoring of stock levels, near-expiry inventory, and patient cluster dynamics
• Coordination with Supply Chain, Finance, and Commercial teams for integrated planning processes
• Close collaboration with General Manager and Sales Leads to define analytical priorities and business requirements
• Presentation of complex analyses and strategic recommendations to leadership and cross-functional teams
• Partnership with Medical Affairs, Marketing, and Sales to gather market intelligence
• Facilitation of annual business reviews and support of strategic planning processes

Business Life Science Analyst

Director

• Provide epidemiology and statistical analytical support for RWE studies
• Contribute to the development of evidence generation plans and design of RWE studies for scientific and regulatory purposes
• Advise study teams on research methodologies and statistical analysis approaches/techniques
• Create and execute (or oversee the execution of) analytic plans for RWE studies
• Ensure epidemiology perspective is adequately and appropriately reflected in study documents
• Prepare and presents study results for inclusion in conference abstracts, presentations, and scientific publications
• Interact with authors, referees, and in-house reviewers
• Represent the GRWE team during interactions with key external stakeholders

Director, Epidemiology – Biostatistics

Business/Life Science Analyst

Account Manager

• The Clinical Account Manager (CAM) acts as the primary customer contact for sales demand creation by executing marketing strategy and promoting Sobi products as led by the National Commercial Business Director calling on Rheumatologists.
• Provides current and comprehensive clinical knowledge of Sobi’s products and effectively communicates the on-label information about the products.
• 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.
• Develop and implement a territory business plan, conducting weekly analysis of sales data to prioritize physician calls and ensure accurate reporting, all while maintaining strict compliance with all corporate, regulatory, state, and federal guidelines.

Clinical Account Manager – Central Plains

Operations

• Manage the ongoing business relationship with Sobi’s third-party logistics providers (“3PL”).
• Overseeing the 3PL function requires working cross-functionally to drive issue resolution and continuous improvement of processes.
• Responsible for implementation of strategies that bring value to Sobi and its Trade channel customers.
• Excel at working cross-functionally and collaboratively with many internal stakeholders including, Order Fulfillment, Supply Chain, Logistics, Finance and Quality.
• Account Management to ensure operational flow of order activities between 3PL and distribution centers/trading partners in North America.
• Management of day-to-day operations of the 3PL and the services it provides to Sobi, including, but not limited to coordination and oversight of inbound products and inventory; order processing and distribution; inbound and outbound logistics (shipment/transportation); pack outs, DSCSA, product damage and temp excursions, etc.
• Conduct scheduling and planning activity meetings to ensure product availability at 3PL meets direct customers’ needs; daily monitoring of direct customer orders and sales.
• Engage with Trade customers to address questions and resolve issues related to customer account set up and account maintenance, customer orders and 3PL shipment delays.
• Contract negotiations, implementation and oversight of contractual requirements.
• Ensure adherence to the operational components of the 3PL Distribution and Services Agreement.
• Partner with 3PL to identify appropriate shipping solutions (e.g., trucks/validated shippers, EPTN lanes) to deliver product successfully.
• Responsible for risk assessment and mitigation of Trade Order Fulfillment Processes of the 3PL and aligning them with Sobi’s standards and practices.
• Develop and implement performance requirements and reportable metrics for the 3PL to measure against Sobi’s standards for trade customer’s timely access to Sobi’s portfolio.
• Responsible for the analysis of the 3PL’s scorecard metrics and publication of performance to key internal stakeholders.
• Development and coordination of 3PL performance improvement initiatives, ensuring accountability to performance expectations.
• Drive process improvements with the 3PL, including development of continuous improvement plans and fostering process improvement behaviors.
• Monitor SOPs, work instructions, job aids, and business rules to ensure compliance by 3PL to Sobi requirements.

Director of Trade Operations

Project Manager

• Provide strategic leadership and hands-on project management expertise to ensure successful launch of uncontrolled gout asset
• Lead the end-to-end launch planning and execution process
• Provide leadership and coordination to a cross-functional team

Director of Project Management

• 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 calling on Rheumatologists.
• The CAM provides current and comprehensive clinical knowledge of Sobi’s products and effectively communicates the on-label information about the products.
• 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.
• Develop and implement a territory business plan, conducting weekly analysis of sales data to prioritize physician calls and ensure accurate reporting, all while maintaining strict compliance with all corporate, regulatory, state, and federal guidelines.

Clinical Account Manager

• Sobi is seeking a highly experienced, passionate Field Reimbursement Manager.
• Reporting to the Director of Field Reimbursement in the Immunology Franchise, the Field Reimbursement Manager (FRM) is an important member of the Sobi Market Access team.
• The FRM role is a field-based, non-promotional resource for infusion centers, health systems, institutions, hospitals, and HCP practices/groups that serves as the key to help unlock patient access and resolve reimbursement issues.
• The successful candidate brings strong knowledge and proven work history of access and reimbursement for buy-and-bill/infused pharmaceutical products.
• The FRM, in addition to working closely with external customers, will work with numerous internal teams, including Patient Services, Market Access colleagues, Medical Affairs, Advocacy, and Marketing to facilitate and support patient access to treatment.
• The FRM is a critical component of customer support and will rely on strong problem-solving skills to provide outstanding customer experiences and outcomes.
• Customer Engagement: As a field reimbursement manager, the FRM is expected to maintain a targeted account list of customers and proactively engage accounts live and virtually.
• Proactively and consistently working with assigned customers to educate on access and reimbursement as well as build and maintain relationships with all relevant departments and personnel, including but not limited to Infusion Center Manager, Biologic Coordinators, Reimbursement Specialist/Coordinator, Patient Access Specialist, Financial Counselors, Billing and Coding Specialists, Nurse Navigator, Pharmacists, Revenue Cycle Manager, Patient Advocates and prior authorization specialists.
• Acting as the subject matter expert with a deep level of understanding of buy and bill reimbursement and access & reimbursement across all channels (Commercial, Medicare, Medicaid, Government) who educates and identifies compliant solutions to overcome patient access and reimbursement issues.

Medical Excellence Manager

Global Omnichannel Customer Engagement Lead

Global Omnichannel Customer Engagement Lead

Global Omnichannel Customer Engagement Lead

Medical Excellence Manager

Global Regulatory CMC Lead

Medical Excellence Manager

Business Life Science Analyst

Director, Epidemiology – Biostatistics

Business/Life Science Analyst

Clinical Account Manager – Central Plains

Director of Trade Operations

Director of Project Management

Clinical Account Manager

Field Reimbursement Manager, Immunology