Sobi - Swedish Orphan Biovitrum AB (publ)

Customer Success Manager

• Responsible for delivering seamless and engaging experiences for healthcare professionals (HCPs) and other key stakeholders 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 engage affiliates in effective deployment across channels
• Experience in rep triggered and blast emails, webinar platforms, HCPs portals, content tagging, Veeva and KAM orchestration is essential
• Communicate to stakeholders at all levels with clarity and vision
• Shape the digital and omnichannel roadmap for Sobi

Global Omnichannel Customer Engagement Lead

Supply Chain

• Lead the supply chain topics, ensuring accurate demand planning, replenishment, and inventory management across European portfolio
• Oversee business processes with the affiliates
• Continuously improve the supply chain using digital and data-driven industry 4.0 standards
• Execute cluster/affiliate Demand Planning meetings to align stakeholders on demand management, supply, and inventory levels
• Develop S&OP process, promote its tools cross-functionally, ensure consensus forecasts

Supply Chain Associate Director

Director

• Support the MPL (Hematology) to build and execute global medical strategy/plans, including the following deliverables
• Build and execute global medical strategy/plan and tactical plan
• Manage engagement of global KOLs in the field
• Co-leading evidence generation workshops
• Review and answer any Medical Information questions, as needed
• Support development of reactive slides decks for external use on relevant data
• Input to clinical studies in phase 3-4
• Support scientific communications with internal cross functional colleagues
• Facilitate and support external and internal training and training material
• Give scientific input to external and internal scientific publications
• Support to cross-functional projects
• Provide scientific input, review and approval to the development of promotional material driven by the commercial team

Associate Director, Global Medical Affairs – Global Medical Lead, Haematology

Account Manager

• 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
• 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, 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

Hematology Clinical Account Manager – Senior

• Lead medical strategy and serve as primary point of contact for the cross-functional global brand team
• Act as subject matter expert with deep knowledge of the therapeutic indication and relevant clinical data
• Build and execute global medical communication and tactical plans in collaboration with the medical team
• Manage and strengthen relationships with global key opinion leaders (KOLs)
• Develop and disseminate scientific communications, including support for the publication plan
• Provide scientific and medical input to materials developed by commercial, HEOR, Access, and patient engagement teams
• Create training materials and deliver internal and external scientific education
• Act as trusted representative of Sobi in interactions with external collaborators, stakeholders, and partners

Global Director, Medical Affairs

Associate Director – Global Medical Affairs, Global Medical Lead – Haematology

• Develop SP/SD pipeline partners for Sobi’s current and future portfolio needs
• Develop and maintain integrated business plans for SP/SD Department which measure specialty pharmacy progress and performance
• Measure SP/SD program performance on a monthly and quarterly basis, communicating results to leadership, and cross functional teams
• Build strong relationships with wholesalers and specialty pharmacies to ensure awareness of Sobi’s products and pricing
• Support day-to-day activities with distribution partners to ensure effective and efficient delivery of products to end-user customers
• Analyze the local environment and align Sobi’s priorities to develop trade customer plans that deliver on defined business objectives
• Develop and execute account-based product distribution / new product launches and inventory management plans aligned to current and future brand strategy, including gross/net financial goals
• Collaborate on the returns process from customers; identify any variances from expected levels of returns and recommend any changes needed to Returned Goods Policy
• Collaborate with Distribution Operations to ensure data reporting and supply chain needs are aligned with account needs
• Oversee trade customer returns to ensure compliance with Sobi’s Returns Policy
• Maintain open communication across the organization, particularly regarding cross-region and cross-functional customer efforts
• Provide insights into channel trends and monitor distribution services to ensure optimal performance
• Exercise sound judgment to ensure integrity and compliance with company policies and regulatory guidelines in all activities and communications

Associate Director – Trade Relations

• Serve as strategic partner and driver of strategic initiatives that enhance patient access to therapies and improve overall patient experience.
• Build strategic knowledge and relationships to adopt new technology solutions to further enhance operational efficiencies for our financial assistance programs.
• Identify and implement new services, program enhancements and operational efficiencies to improve patient engagement and service delivery.
• Drive operational excellence and continuous improvement across patient support programs.
• Lead and monitor day to day to operations and strategy of Patient Support and financial assistance services to ensure high quality performance and adherence to contractual requirements.
• Monitor key performance indicators (KPIs) to assess program effectiveness and drive continuous improvement.
• Utilize program specific data reports to identify trends, present insights, and suggest opportunities for improvement.
• Collaborate with internal and external stakeholders to ensure the highest standards of patient care and support.
• Partner with Market Access, Sales, Marketing, Medical Affairs, and Compliance teams to align patient services initiatives with broader business objectives.

Associate Director – Patient Services

Manager

• The Medical Advisor is the medical and scientific point of reference for Tryngolza, an advanced therapeutic option for Familial Chylomicronemia Syndrome (FCS).
• Acts as the point of contact for healthcare professionals, particularly regarding medical information, clinical studies, and scientific partnerships.
• Submit reports of pharmacovigilance/materiovigilance known to them from healthcare professionals and patients/users.
• Propose and develop, in partnership with the Associate Medical Director, the medical strategy for Tryngolza (FCS and sHTG).
• Lead and supervise medical, scientific, and development projects.

Medical Advisor

Medical writer

• Provide communication expertise and lead a strategy-driven approach to authoring key clinical and regulatory documents
• Assume primary responsibility for preparation of key clinical and regulatory documents
• Provide leadership and project coordination to cross-functional authoring teams
• Liaise with senior project staff, develop a storyboard for the submission, and plan document development
• Ensure high technical quality of documents in compliance with in-house technical requirements
• Coach and develop less experienced Medical Writers

Principal Medical Writer

Compliance

• Responsible for all aspects of the US Regulatory Strategy for assigned development and marketed products
• Core member of the Global Regulatory Team (GRT) providing US-focused product strategy
• Points of contact within GRA on the core asset team (CAT) and Medicines Development Team (MDT)
• Ensures guidance on regulatory pathways to accelerate product development is evaluated and included
• Prepares cross-functional team for major FDA Meetings and leads/facilitates major meetings with the Agency
• Contributes to Submission Taskforce meeting and efforts to ensure timely and quality submissions

Regulatory Strategy Lead

• Supporting transition from legacy paper-based processes to a scalable and compliant Electronic Quality Management System (eQMS)
• Ensuring Quality System supports all stages of drug development — from nonclinical development through clinical development, regulatory submission (IND, NDA/BLA), commercialization, and product lifecycle management
• Ensuring compliance with applicable GxP requirements (GLP, GCP, GMP), applicable FDA and global regulatory expectations, and industry best practices
• Supporting inspection readiness, regulatory submissions, vendor oversight, and fostering a culture of quality and compliance across the organization

Quality Operation Manager – GMP

Product Manager

• Subject matter expert (SME) and process owner for Drug Product (DP) manufacturing of a small molecule used in non-sterile dosage forms
• Oversee all technical drug product manufacturing aspects (fully under GMP) for a small molecule manufactured at an external manufacturer
• Lead the technical workstreams of product transfers from development to commercial site and between commercial sites, scale-up activities, process validations and oversees manufacturing of Drug product with a small molecule at external manufacturers for projects in clinical and commercial phase
• Lead internal activities related to external manufacturing such as process change assessments, major/critical deviations, risk assessments and CAPAs
• Review and supervise set up, execution and documentation of DP related technical studies (CMC development and commercial operations), process and equipment qualifications and validations.
• Write and review applicable sections in registration files, variations and market expansion
• Issue, review and approve applicable internal and external SOP's and external manufacturer manufacturing instructions
• Contribute during set up of new analytical specifications and stability programs and review changes thereof
• Support in sourcing evaluation of new Drug product small molecules, hard-gelatine capsule based alternative contract manufacturers and participation in developing supply and quality agreements
• Be aware of external manufacturing technology advancements, understand and introduce new technologies and how they may be applicable to process innovation, cost or yield improvement

Drug Product Lead

• Perform as EQOM to act as Single point of contact for all quality related activities at the Contract Manufacturing Organization (CMO)
• Ensure that all aspects of handling, manufacturing, distribution of products are in compliance with Sobi Quality system, the effective Quality Technical Agreement (QTA), that they meet relevant CGMP regulatory requirement
• Support release products to Markets
• Support the External Service Provider (CMO) Qualification
• Ensure Quality Technical Agreement (QTA) be established appropriately and ensure valid QTA clearly defines roles & responsibilities between Sobi and the External Supplier
• Ensure implementation and maintaining Quality Risk Assessment and KPIs on Quality External activities
• Guide defining & monitoring remediation plans to ensure that issues are suitably addressed
• Drive or support improvement opportunities for processes and product Quality performance
• Ensure CMO provides product reviews or data (APQR/PQRs, stability reports) as specified in the QTA
• Assess the performance of the product and the process as per Sobi requirement
• Manage/approve quality issues (deviations, CAPA and complaints) as per QTA and Sobi requirement
• Ensure that Change requests either from CMO or from Sobi are managed according to the QTA and Sobi requirements
• Support that Quality Audits of the CMO are performed according to Sobi requirement and the QTA
• Lead to define strategy of implementation and monitoring of key Quality transformation initiatives and align with all process stakeholders outside of Quality organization
• Lead or act as Quality representative in projects related to CMO eg Tech Transfer, Launch
• Assess and ensure CMO for Health Authorities (HAs) inspection readiness
• Support HA inspections/audits of Sobi
• Responsible to inform the line manager and cross functional teams of all critical & major issues and escalate any issues as per Sobi escalation policy
• Ensure a good collaboration is maintained within the Global Quality Operations and cross-functionally
• Ensure the batch release as required

External Quality Operation Manager – GMP

Program Manager

• Lead an international cross-functional technical CMC team, associated functions like Quality and impacted CMO/CLOs to deliver all required technical documentation supporting an approvable NDA Module 3
• Project manage all key CMC deliverables, incl underlaying reports
• Coordinate team interactions ensuring team meetings have structure and purpose
• Assure integrated program plans are in place including cross-functional interdependencies
• Coordinates the identification and mitigation of program issues and risks
• Coordinating the review process of technical documents (ie, protocols, reports, master and executed batch records, change controls, deviations, etc.)
• Responsible for program budget and long-term projections – budget planning and tracking