argenx

Communications

• Manage the overall development and approval process for assigned documents within timelines
• Coordinate internal stakeholder and author interactions, develop project timelines, maintain compliance with publication industry and company standards and ensure timely achievement of project milestones
• Supervise/monitor communications vendors to optimize timely development of materials
• Ensure timely communication and follow up with all key stakeholders
• Provide updates of scientific publication activities on a regular basis

Senior Manager, Scientific Communications

Compliance

• Design and implement a next-generation Risk Assessment and Mitigation Plan (RAMP) framework using AI, machine learning, behavioral patterns, and data analytics to proactively identify emerging compliance risks.
• Collect and analyze data to identify emerging global risks, control gaps, fraud, or non-compliance, and deliver clear reports and dashboards to inform strategic risk decisions and assess compliance controls.
• Developing, implementing, and enhancing a dynamic monitoring framework, including collaboration with Internal Audit and other teams that regularly audit argenx business activities such as Quality, Finance and those of our third-party partners.
• Ensure timely, high-quality monitoring reports with executive summaries, root cause analysis, and clear, actionable recommendations, leveraging improved tools and processes for continuous enhancement.
• Maximize collaboration with external partners to oversee the execution of monitoring activities by embracing the argenx ways of working, fostering shared accountability.
• Innovatively explore and expand the scope of monitoring in emerging risk areas such as trade sanctions, social media, data privacy, digital engagement, and AI-driven business processes.
• Drive strategy and plan for live monitoring activities such as field ride-alongs, speaker programs, and advisory board meetings to assess compliance with company policies, identify potential risks, and ensure adherence to regulatory requirements.
• Implement robust processes to ensure the quality, integrity, and traceability of data used in risk assessments and monitoring activities.
• Serve as the primary compliance contact for Internal Audit, supporting planning, documentation review, testing, and remediation efforts.
• Support compliance investigations, contributing to root cause analysis and outcome reporting.
• Oversee third-party risk management activities, including anti-bribery/anti-corruption due diligence, background checks, and trade sactions screening, to ensure compliance with compliance standards and regulatory requirements.
• Support gap assessment efforts to ensure completion of actions derived from maturity assessments, ensuring transparency, consistency, and defensibility of risk-related decisions.
• Willingly assist LCIP team with projects and activities in areas outside of own primary areas of responsibility as needed to achieve corporate objectives.

Associate Director, Ethics & Compliance – Risk Assessment and Monitoring

Operations

• Drive asset readiness in partnership with cross-functional project owners and agency partners, proactively identifying risks and escalating potential delays to keep launch timelines on track.
• Lead execution of label change activities, coordinating updates across all impacted assets and ensuring timely deployment in compliance with mandated implementation deadlines.
• Partner with Print & Fulfillment Operations to oversee Prescribing Information (PI) updates for promotional and medical print assets.
• Partner closely with the Manager, MRC Operations to align on material forecasting, volume projections, and prioritization of launch-critical assets to ensure efficient resourcing and timely reviews.
• Collaborate with MRC Operations to integrate launch timelines into daily committee processes, ensuring seamless coordination between ongoing reviews and upcoming deliverables.
• Participate actively in launch readiness workstreams, providing updates on MRC asset status, milestones, and risks to promote organizational visibility and alignment across functions.
• Own and maintain trackers, dashboards, and reports, and ensure accuracy of MRC operational procedures, templates, and best practices to support compliance, operational excellence, and timely delivery of launch-critical materials.

Manager, MRC Launch Operations

Project Manager

• The RPM partners with PM and Regulatory Leads as applicable and consults other Submission Team members to create an integrated and dynamic operational regulatory submission plan in support of projected global regulatory approval for assigned asset(s) in targeted regions, and therapeutic indications and/or presentations per corporate strategy
• Scenario planning taking into account all submission activities that rely on resources needed for assigned submission plans
• Creates visuals, reports to facilitate awareness of key milestones, closely monitors critical path activities, and ensures transparency of submission status to stakeholders; anticipates delays and mitigates impact to timelines
• Ensures submission team is aware of upcoming deliverables, aligned on roles and responsibilities, understands the interdependencies between submission activities and meets target submission dates
• Enables function leads to ensure that all documents are prepared with global Regulatory/ Health Authority quality standards
• Leads submission planning discussions incl., setting agendas, minutes and follow up on key actions with stakeholders
• Works with functional teams to identify ways to optimize and accelerate submission timelines
• Partners with PMs to ensure submission project plan and cross-functional project plans are aligned and optimized
• Manages submission planning meetings, including agenda preparation, minute-taking, communication of decisions; tracking and resolution of action items
• Translates post-submission requirement into an executable post-submission plan
• Identifies any issues, risks, or impact due to changes in strategy and/or timelines throughout the submission process
• Identifies key learnings & best practices and shares lessons learned across programs in order to refine and improve submission processes
• Contributes to the development of the Project Community Centre to share best practices and tools across argenx Project Management community
• Leads and/or participates in cross-functional and functional workstreams/initiatives.

Senior Regulatory Project Manager

Manager

• Assists in the prompt and accurate responses to medical information requests from internal and external customers through the MI Response Center, email, fax and websites for US, Canada and Global
• Assists in the documentation of the inquiries and responses accurately and completely comply with relevant Standard Operating Procedure (SOP)/ Work Instruction and regulatory guidelines
• Ensures that adverse events and product quality complaints are processed in accordance with company SOPs
• Assists in the creation, review and maintenance of MI documents by ensuring that responses are medically and scientifically accurate, timely, balanced, and meet customers’ needs
• Ensure the highest degree of quality and medical accuracy for all outputs developed
• Liaise with publications and clinical development groups to develop and maintain timely and relevant product expertise
• Perform critical analysis and synthesis of internal/external literature related to argenx products and therapeutic areas of focus
• Supports internal teams by providing literature reviews and medical and scientific information related to argenx therapeutic areas
• Exhibits broad knowledge of assigned therapeutics areas, product labelling and regulatory guidance
• Assists in maintenance of relevant knowledge repositories, including medical information responses and publications
• Appropriately liaise with Drug Safety and Quality regarding adverse events and product complaints, ensuring systematic capture and timely reporting
• Manages materials through the US medical, legal and regulatory review process as appropriate
• Completes all work in accordance with regulatory requirements, industry standards, and argenx policies
• Serves as medial affairs liaison to cross-functional groups for the incorporation of current medical/scientific information into department documents and processes.

Senior Manager, Medical Information – Customer Management

• Serve as the Medical Reviewer for scientific accuracy in the US Materials Committee (MRC)
• Provide independent medical review to ensure statements are scientifically valid and accurate, truthful and not misleading, including the appropriateness of references cited
• Communicate and collaborate effectively with Medical Review Community to cultivate a positive relationship
• Serve as Librarian for reference evaluation for use in the US Material Review Committee (MRC)
• Maintain scientific knowledge, including: labeling, associated therapeutic areas, relevant literature, treatment guidelines and competitor information, through ongoing internal and external data sources (e.g., training, conferences)

Senior Manager, US Medical Promotional Review

• Coordinate new hire training support during onboarding, home study, and application training
• Manage training content requirements for new hires, regional, and national meetings for all field-based roles
• Design, develop, and implement sustained learning programs to increase skills, knowledge, and performance of field teams
• Build training content for future product indications
• Identify learning/training gaps and implement solutions to address needs
• Collaborate proactively with marketing and other internal stakeholders to ensure field training aligns with brand messaging
• Manage the MRC (medical, regulatory, and legal) process for new and existing training materials
• Lead the identification, selection, and day-to-day management of vendors, including SOW and PO generation and vendor management
• Contribute to both regional and national meetings throughout the year

Senior Manager, Field Training

Content Writer

• Serve as the primary point of contact for CRO medical writing teams and ensure alignment with company standards, timelines, and expectations
• Onboard and train CRO medical writers as needed
• Provide document-level guidance, review, and final approval oversight for CRO-authorized deliverables (eg, protocols, protocol amendments, clinical study reports, informed consent forms)
• Ensure consistent scientific messaging and adherence to company lexicon, style guides, and quality standards across outsourced deliverables
• Monitor CRO performance metrics (quality, timeliness, compliance), and participate in governance meetings, if applicable
• Identify training or quality improvement needs for vendor teams and coordinate targeted upskilling or remediation
• Develop and maintain medical writing governance frameworks for outsourced deliverables, including SOPs, templates, and quality control/clinical editing processes
• Ensure alignment of outsourced documents with internal data strategy, key messages, and regulatory objectives
• Partner with cross-functional teams to ensure outsource writers have appropriate context and access to subject matter experts
• Contribute to vendor selection and evaluation processes, including defining medical writing requirements and KPIs
• Ensure quality review and continuous improvement initiatives within the medical writing outsource model
• Support internal writers and reviewers in effectively collaborating with CRO partners
• Participate in defining and refining the outsourced MW model
• Represent MW in vendor governance/operational review forums
• Engage relevant SMEs and document owners to directly author content that is well-organized, consistent, accurate, and appropriate for a regulatory audience
• Responsible for the inspection-readiness of medical writing activities
• Facilitate standardization of documents using document templates, lexicons, and the argenx style guide to ensure the quality and consistency of documents across programs
• Responsible for medical writers assigned to support the medical writing activities for a particular project
• Executes corporate objectives, goals, measures, and strategies and begins to inform the development of them
• Capable of working on multiple deliverables simultaneously

Associate Director, Medical Writing – CRO Oversight

• Independently manage medical operations for all Field US Medical Affairs led KOL engagements including Visiting Professorships, KOL Lectures, Regional Roundtables, Advisory boards, MSL Education Dinner Program and Ad Hoc Consultations.
• Partner with Compliance during the review and approval process for all US Medical Affairs led programs, managing any escalations that may be required.
• Partner with Legal team to ensure contracts are developed and executed for each program prior to the execution of the program
• Ensure all field medical business justification forms are submitted for Compliance approval according to the argenx standards
• Act as primary point of contact for all relationships with USMA&EG vendors (supporting field activities) to ensure timely execution of contracting, scheduling, content submissions for KOL engagements.
• Manage day-to-day vendor relationship including onboarding, training, process/guidance updates and escalation for all KOL engagements.
• Manage the onboarding of all new field medical personnel (liaising with MSLs and BIS/IT for systems access and resolve any issues), manage distribution lists and SharePoint access, introductory meetings and credentialing
• Maintain Medical Affairs maps/profiles and rosters for all new field hires
• Work with Field Medical Leadership to support territory planning initiatives and ensure alignments are captured in Veeva Align and Veeva CRM.
• Partner with Field Medical Leadership on medical budget development and management including MSA/SOW/PO processing, invoicing issues, and monthly tracking.
• Lead implementation of technological enhancements and fixes for Veeva CRM and MSL Dashboard.
• Created monthly reporting on key field activities, including interactions and insights for leadership team.
• Supporting training team and directors to deliver MSL trainings on new content, data, upskilling etc.
• Collaborate with executive leadership support team to ensure calendar availability for all programming executed by Med Affairs and Field Medical teams
• Support logistics and agenda development for MSL team meetings

Field Medical Operations Manager

Marketing

• Develop, execute and drive the marketing strategy, ensuring alignment with global brand objectives and local market needs
• Prepare and execute (pre-) launch campaigns across Austria and Switzerland through an omnichannel approach
• Create and oversee the annual marketing business plan, including budget allocation, campaign development, and performance metrics
• Create marketing materials for different stakeholders according to local market needs and in collaboration with country field teams
• Collaborate with cross-functional country teams to ensure a consistent and effective go-to-market strategy
• Conduct market research, competitor analysis, and customer insights to identify opportunities and threats
• Implement and measure marketing campaigns, tracking key performance indicators (KPIs) and adjusting strategies as needed
• Manage relationships with external agencies and vendors to support marketing initiatives

Senior Marketing Manager

Director

• Advise on and create early nonclinical safety screening strategy including data generation for the selection of relevant species to ensure smooth transition from discovery to IND-enabling studies
• Design, development and oversight of nonclinical safety package from IND/CTA through BLA.
• Obtain buy-in from all stakeholders and ensure alignment with project team goals.
• Follow up outsourced activities and discuss with experts at the partner companies.
• Closely work with argenx study monitor and PharmToxBA team on implementation of strategy, including planning, execution and close out of individual studies.
• Ensure compliant execution of studies by study monitoring either in person or with support of study monitor.
• Coordinate contributions of other sponsor disciplines (CMC, Bioanalytics, Pharmacokinetics).
• Collaborate with other scientific disciplines to interpret the study outcomes and present at internal multidisciplinary project teams.
• Present and contribute to discussions at senior management forums.
• Actively contribute to the development strategy at internal multidisciplinary project/clinical team meetings.
• Collaborate with medical writer and regulatory affairs in development of regulatory dossiers and the investigator brochure while ensuring nonclinical safety-related content is correct and comprehensive.
• In collaboration with the program manager, ensure correct financial and project planning.
• Provide guidance on how to effectively engage with Health Authorities to receive their feedback in a timely manner.
• Play an active role in shaping the asset development strategy during internal multidisciplinary project/clinical team meetings.
• Work with Sourcing and the program manager to oversee the timely commissioning of studies to CROs, and participate in vendor alliance governance meetings when appropriate.

Director, Toxicology

Financial Planning and Analysis

• Serve as the strategic finance partner to Global and regional Commercial leadership
• Drive a consistent commercial forecasting and performance rhythm aligned with Corporate FP&A
• Own the commercial forecast calendar; ensure driver-based submissions and robust variance analysis
• Elevate price/volume/mix modeling, launch tracking, and dashboarding to sharpen in-market performance insights
• Build pragmatic scenario assumptions and embed them in plans, guidance drivers, and regional targets
• Link demand–supply–finance with emphasis on P&L impacts
• Operate with a public-company (SOX) mindset; standardize processes and tools
• Influence cross-functional stakeholders to help drive adoption and outcomes

Global Commercial FP&A Lead

Software Engineer

• Provide strategic clinical development guidance during early asset development
• Potential Line management of the medical doctors working on the asset
• Maximise internal client satisfaction through collaboration with senior management and functional leaders
• Foster cross-functional collaboration to streamline procedures, training, and efficiency across the organization
• Build and maintain a high-performing clinical development team

Senior Developer

• Determines early market access potential, pricing and strategy for pipeline indications and assets including indication sequencing, TPP, and TPL
• Work with Indication Development Teams (IDTs) to optimize trial designs so they reflect payer requirements
• Coordinate Early Scientific Advice from key HTA Agencies and conduct gap analyses with external consultants
• Work with Indication Commercial Teams (ICTs) to align Access and Commercial positioning, pricing and strategy
• Assess unmet need, outline payer value proposition, assess P&R / HTA landscape and product outlook
• Inform development of global pricing strategy and policy
• Test payer value messages, pricing expectations, and value proposition via Advisory Boards and research with payers / HTA
• Develop core value dossier and objection handler
• Develop innovative access strategies on a global and regional level including early access, and evaluate implications for launch (go, no-go risk mitigation and scenario planning)
• Build out and validate contracting options and G2N assumptions
• Partner with HEOR and Regional Access to optimize the evidence generation plan, identify epidemiology and the unmet medical need
• Inform the development of health economic and outcomes analyses (CEA, BIA, burden of disease, etc.) required for access
• Facilitate launch readiness workshops with regional and local Market Access and other functions

Director, Market Access – Pipeline

• Develop and lead media strategy to drive branded and unbranded engagement across digital and non-personal channels targeting healthcare professionals
• Lead the development and execution of high-impact campaigns that integrate digital, media, and non-personal tactics to achieve brand goals and fuel growth
• Collaborate and co-create with multiple functional groups including Marketing, Marketing Operations, BIS, Medical Affairs, Market Access, Compliance, Legal and Regulatory
• Inspire and manage agency partners to deliver innovative, on-time, and on-budget campaigns and creative assets
• Leverage data and insights to measure performance, uncover opportunities, and continuously optimize media and digital initiatives
• Contribute to strategic brand planning, annual planning and budget discussions
• Partner with personal promotional (PP) to align strategy and tactics and optimize data analytics
• Navigate the Promotional Material Review process, working closely with Legal, Regulatory, and Medical Affairs to prioritize projects and ensure timely, compliant development of HCP-directed tactics
• Support the VYVGART brand, launch readiness, and quarterly business reviews; reports to Sr. Director, US HCP Marketing – MG Indication Lead

Associate Director, HCP Marketing

• Lead pricing initiatives, aligning them with broader portfolio strategies across the Neurology and mid to late-stage portfolio assets
• Ensure alignment with brand, portfolio, and access strategies across therapeutic areas in close collaboration with Global Commercialization Community
• Develop and refine pricing models with emphasis on ASP management across all portfolio assets
• Collaborate with Head of US Contracting Operations by leveraging pricing strategies and innovative contracting strategies to maximize revenue growth through portfolio-based solutions
• Conduct thorough price commitment reviews and affiliation checks to ensure accuracy and compliance
• Conduct customer market research on pricing discussions and insight gathering
• Ensure readiness for upcoming launches by aligning pricing strategies with launch sequencing and market access priorities
• Partner with HEOR teams to integrate evidence into pricing research, insights and decisions
• In close collaboration with legal, IST, finance, and Market Access, lead the discussion on the development of pricing strategies
• Ensure all pricing governance processes and approvals adhere to financial policies
• Monitor pricing trends and customer analytics to drive data-informed decisions
• Establish clear governance processes, SOPs, and playbooks to support pricing operations, actions and ensure audit readiness
• Implement and oversee pricing systems, dashboards, and contract management tools to enable efficiency and transparency
• Collaborate closely with Commercialization Community, US Finance and US Market access to ensure broad coverage and affordability for pipeline assets
• Collaborate with Finance, with Market Access inputs, to monitor factors contributing to GTN
• Collaborate with leadership on tool development and messaging for payers, pharmacies, and physicians
• Oversee market access forecasts, dashboard development, and KPI reporting
• Leverage data and analytics, payer insights, and scenario modelling to inform pricing, contracting, and FTN optimization
• Serve as a core member of the US Market Access Leadership Team

Director, Pricing Operations

• Lead organizational transformation and cross-functional strategic projects for US Medical Affairs & Evidence Generation (USMAEG).
• Lead the annual operating plan (AOP) and ongoing re-forecast cycles for the USMAEG portfolio, including launch scenario modeling and alignment with leadership and Finance.
• Establish molecule- and indication-level budget trackers; monitor burn rates, identify variances, and drive mitigation actions with Finance.
• Own monthly/quarterly forecasting and prepare accruals in conjunction with Finance partners.
• Manage end-to-end procure-to-pay (P2P) for USMAEG: vendor onboarding, requisitions, PO creation/amendment, and invoice processing to policy and cycle-time targets.
• Develop, negotiate, and execute Statements of Work (SOWs) and change orders with vendors; define scope, deliverables, acceptance criteria, and milestone-based payment schedules with Legal and Procurement.
• Build dashboards and reports (e.g., Excel, Power BI) providing real-time visibility into budget consumption, forecast accuracy, and vendor performance.
• Design and execute cross-functional programs; develop integrated plans, timelines, budgets, and KPIs.
• Lead change management to drive adoption of new processes and systems; facilitate decision-making routines and executive updates.
• Identify and implement process improvements and automation to streamline operations and increase data quality and scalability.
• Coordinate stakeholder and vendor engagement to ensure alignment on objectives, deliverables, risks, and interdependencies.
• Partner with all functions and teams (HQ & Field) across USMAEG as well as Finance, Legal, MAEG and Procurement partners to align plans and enable execution.
• Facilitate budget-to-milestone linkage with medical value narratives for leadership and governance reviews.

Medical Affairs Operations Manager, Business Project and Operations, BPO

• Nurse Case Manager (NCM) is single point of contact for patients and caregivers
• Align regionally to educate patients, caregivers and families affected by generalized Myasthenia Gravis (gMG)
• Provide direct educational training and support about gMG and prescribed argenx products
• Provide resources to help patients manage their disease and coordinate treatment
• Participate in one-on-one communications with patients and caregivers
• Manage patient cases across regions as coverage and volume requires
• Communicate insurance coverage updates and findings to patients/caregivers
• Review and educate patients/caregivers on financial assistance programs eligibility
• Coordinate logistical support for patients to receive therapy and manage disease
• Collaborate with Patient Access Specialist, Case Coordinator, Field Reimbursement Manager to resolve reimbursement issues
• Engage with provider case coordinators to ensure individualized support
• Empower patients through patient-focused education to advocate for themselves
• Develop relationships and manage complex challenges facing patients and caregivers
• Ensure compliance with relevant industry laws and company policies
• Aligned regional travel required to support patient programs (less than 50%)

Nurse Case Manager

Director, Patient Experience Analytics

• Assists in developing and implementing patient support case management processes, identifying patient needs and utilizing resources
• Manages patient access needs in treatment initiation and onboarding, collaborating with third-party partners and internal access teams
• Evaluates patient case data to ensure support is provided in accordance with clinical guidelines and organizational standards
• Demonstrates leadership/example in all aspects of compliance including program, data privacy, ongoing education, and pharmacovigilance (PV) adherence
• Maintains and monitors quality case management documentation to assure compliance with program, data privacy, ongoing education, and PV adherence
• Demonstrates strong communication skills with internal and external constituents and utilizes all available internal cross functional departments and available reporting tools to strategize the achievement of company goals