argenx

argenx

6 open positions available

1 location
1 employment type
Actively hiring
Full-time

Latest Positions

Showing 6 most recent jobs
argenx

Territory Business Manager, Denver South, CO

argenxAnywhereFull-time
View Job
Compensation$120K - 180K a year

Drive demand generation and sales objectives in assigned territory through collaboration with healthcare professionals and internal teams. | 5+ years of specialty/rare disease or biologics sales experience, preferably in neurology, proven high sales performance, and willingness to travel extensively. | Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. At argenx, we build our culture from the collective power of the team and the knowledge that together, we are better. We are one team, one culture, with one purpose. As part of that team, the Territory Business Manager (TBM) for the Neurology Franchise will drive demand generation through a focused approach on healthcare professionals, academic institutions, and specialty pharmacy/infusion providers. Through exemplary collaboration with internal and field-based partners and a patient-first mindset, the TBM will help deliver on quarterly sales objectives within their assigned geography. TBM’s will report into the Strategic Business Leader. The Territory includes Denver, Colorado (South). Roles And Responsibilities • Travel within assigned geography and occasionally beyond • Territory planning and development of local market strategy • Collaborate with regional colleagues and cross-functional team members • Communicate and engage with assigned HCP’s and affiliated staff • Consistently meet and exceed sales objectives • Effective utilization of market tools and resources • Timely submission of account plans and activity including CRM • Adhere to all argenx compliance policies, guidelines and approved sales messages Skills And Competencies • Ability to sell collaboratively • High level of clinical, product, and business acumen • Problem solving • Working effectively together • Results Oriented • Capable in a virtual sales environment • Demonstrates ownership and accountability • Passionate about serving patients • Understanding of market access dynamics, emphasis on specialty pharmacy and buy & bill accounts Education, Experience And Qualifications • 5+ years of specialty/rare disease/biologics sales experience, neurology strongly preferred • Proven track record of consistent high sales performance • Adept at planning, organizing, and executing sales strategy • Demonstrate ability to collaborate with internal stakeholders • Ability to adapt to an ever-changing environment • Experienced in product launches • Align with core values of the organization – co-creation, humility, excellence, empowerment and innovation • Education: B.S. or B.A. degree preferred At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer. Before you submit your application, CV or any other personal details to us, please review our argenx Privacy Notice for Job Applicants to learn more about how argenx B.V. and its affiliates (“argenx”) will handle and protect your personal data. If you have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at privacy@argenx.com. If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at hr.us@argenx.com. Only inquiries related to an accommodation request will receive a response.

specialty/rare disease sales
neurology sales
sales strategy
collaboration
product launches
market access dynamics
CRM usage
Verified Source
Posted 3 months ago
AR

Associate Director, US Medical Review

argenxAnywhereFull-time
View Job
Compensation$Not specified

The Associate Director will oversee the medical review of promotional materials and lead a dedicated indication sub-team within the US Medical Review Community. This role ensures scientific accuracy and fosters collaboration across Medical Affairs, Marketing, Legal, and Regulatory teams. | Candidates must hold a Doctorate degree (PharmD, MD, or PhD) and have over 5 years of experience in the pharmaceutical or biotechnology industry, with at least 3 years in promotional/medical review. Prior experience in Neurology or Rare Disease is preferred. | Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. The Associate Director, US Medical Review will be responsible for overseeing the medical review of promotional materials and leading a dedicated indication sub-team within the US Medical Review Community. This position plays a critical role in ensuring scientific accuracy and cross-functional collaboration across Medical Affairs, Marketing, Legal, and Regulatory teams. The role also serves as the Medical Review lead for co-creation during material development with Marketing and contributes to informed, evidence-based decision-making across the Therapeutic Area ROLES & RESPONSIBILITIES Lead an indication sub-team of Medical Reviewers within the US Medical Review Community, ensuring promotional materials are scientifically accurate, truthful, and compliant with regulatory standards. Provide solutions-oriented feedback and collaborate effectively with cross-functional stakeholders. Represent the Medical Review function in Medical Affairs matrix meetings to support strategic decision-making. Identify and implement process efficiencies within the Medical Review sub-team. Maintain up-to-date scientific knowledge, including product labeling, therapeutic areas, treatment guidelines, publication plans, and competitive landscape. SKILLS AND COMPETENCIES Strong ability to critically evaluate scientific literature and interpret complex data. Excellent written and verbal communication skills tailored to diverse audiences. Proven ability to manage multiple projects, solve problems, and meet deadlines. Effective collaborator in a matrixed environment with a proactive and flexible mindset. Working knowledge of FDA regulations relevant to promotional and medical review. REQUIREMENTS Doctorate degree (PharmD, MD, or PhD). 5+ years of experience in pharmaceutical or biotechnology industry, primarily within Medical Affairs. At least 3 years of direct experience in promotional/medical review. Prior experience in Neurology or Rare Disease preferred. Strong scientific and medical communication skills required. At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer. Before you submit your application, CV or any other personal details to us, please review our argenx Privacy Notice for Job Applicants to learn more about how argenx B.V. and its affiliates (“argenx”) will handle and protect your personal data. If you have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at privacy@argenx.com. If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at hr.us@argenx.com. Only inquiries related to an accommodation request will receive a response. argenx is a global immunology company dedicated to improving the lives of people suffering from severe autoimmune diseases. Through our rich pipeline of first-in-class therapies, led by VYVGART®, we are accelerating progress toward our bold 2030 vision: to reach 50,000 patients and transform the landscape of autoimmune treatment. Our innovation mission combines with meaningful work and endless opportunities for growth to create once-in-a-career experiences. argonauts work in locations around the globe including Belgium, Boston, Japan and Amsterdam. There's more to discover at argenx, where our passion inspires bold possibility. argenx honors the terms of our written agreements with the recruiting and staffing agencies that we retain and contract with to assist us with talent searches and other recruiting needs. Accordingly, all resumes and referrals that recruiting and staffing agencies proactively share with argenx that (i) were not solicited or requested by argenx’s internal Talent Acquisition team and (ii) were sent in the absence of a valid, written agreement between argenx and the firm, recruiter, or agency, may be pursued by argenx and are ineligible for payment of referral or other fees. We encourage you to be cautious of recruiting scams and fictious communications that pretend to be from argenx employees. These scams are designed by fraudsters to get personal information (e.g., social security numbers, bank account information, dates of birth), money or payments from job seekers as part of a “recruiting” process. argenx does not request financial information or money from job seekers. Legitimate emails from argenx employees end in “@argenx.com.” Fraudsters disguise themselves by using similar email addresses (e.g., @argenxhr.com, @argenxcareer.com, etc.) or public domains (@gmail.com, @yahoo.com, etc.). They may use photographs and names of real argenx employees for their fake interviews. argenx does not recruit or post positions on RingCentral, Facebook, or Craig’s List. Our formal recruitment process includes interviews with members of argenx’s talent acquisition team and other interviewers that occur in person at our offices, or via Zoom or Teams video calls. Interview processes that involve a formal offer from argenx will include written employment documentation on official argenx letterhead. argenx takes prompt appropriate and responsive action to fraudulent recruiting efforts when we become aware of them. If you believe you have been victimized by an employment application or a fraudulent recruiting scam, you can contact your local law enforcement authority for guidance or the FBI’s Internet Crimes Complaint Center at www.IC3.gov to file a complaint.

Scientific Literature Evaluation
Data Interpretation
Written Communication
Verbal Communication
Project Management
Problem Solving
Collaboration
FDA Regulations Knowledge
Direct Apply
Posted 3 months ago
Argenx

Nurse Case Manager, Float

ArgenxAnywhereFull-time
View Job
Compensation$85K - 110K a year

Provide patient education and support for generalized Myasthenia Gravis patients, coordinate treatment logistics, manage reimbursement issues, and collaborate with internal teams to ensure patient advocacy and compliance. | Current RN license, 5+ years clinical experience including hospital or pharmaceutical settings, 2+ years case management, strong communication and organizational skills, and ability to travel regionally up to 50%. | Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. The Nurse Case Manager (NCM) is the single point of contact for patients and their caregivers. They are aligned regionally and are responsible for educating patients, caregivers and families affected by generalized Myasthenia Gravis (gMG) about the disease and argenx’s products and support services. The NCM may provide resources to help patients better manage their disease and coordinate their treatment. The NCM is responsible for participating in one-on-one communications with patients and their caregivers. Desired Location: Tennessee Roles and Responsibilities: • Provide direct educational training and support to patients and caregivers about gMG and prescribed argenx products • Will manage patient cases across regions as coverage and volume requires • Communicate insurance coverage updates and findings to the patient and/or caregiver • Review and educate the patients and/or caregivers on financial assistance programs that they may be eligible for • Coordinate logistical support for patients to receive therapy and manage their disease • Collaborate with argenx Patient Access Specialist, Case Coordinator, and Field Reimbursement Manager teams to troubleshoot and resolve reimbursement-related issues • Engage with patients and provider case coordinators to ensure appropriate support is being given on an individualized basis • Provide patient-focused education to empower patients to advocate on their behalf • Develop relationships and manage multiple and complex challenges that patient and caregivers are facing • Ensure compliance with relevant industry laws and argenx’s policies • Aligned regional travel will be required for patient education to support patient programs • Must be an excellent communicator and problem-solver • Demonstrated time management skills; planning and prioritization skills; ability to multi-task and maintain prioritization of key projects and deadlines Skills and Competencies: • Demonstrated effective presentation skills; ability to motivate others; excellent interpersonal (written and verbal) skills – with demonstrated effectiveness to work cross-functional and independently • Demonstrated ability to develop, follow and execute plans in an independent environment • Demonstrated ability to effectively build positive relationships both internally & externally • Demonstrated ability to be adaptable to changing work environments and responsibilities • Must be able to thrive in team environment and willing to contribute at all levels with flexibility and a positive attitude • Fully competent in MS Office (Word, Excel, PowerPoint) • Flexibility to work weekends and evenings, as needed • Participate in and complete required pharmacovigilance training • Comply with all relevant industry laws and argenx’s policies • Travel requirements less than 50% of the time Education, Experience and Qualifications: • Current RN License in good standing • Bachelor’s degree preferred • 5+ years of clinical experience in healthcare to include hospital, home health, pharmaceutical or biotech • 2-5+ years of case management • 2+ years of experience in pharmaceutical/biotech industry strongly preferred • Reimbursement experience a plus • Bilingual or multilingual a plus #LI-Remote At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer. Before you submit your application, CV or any other personal details to us, please review our argenx Privacy Notice for Job Applicants to learn more about how argenx B.V. and its affiliates (“argenx”) will handle and protect your personal data. If you have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at privacy@argenx.com . If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at hr.us@argenx.com . Only inquiries related to an accommodation request will receive a response.

RN License
Case Management
Patient Education
Pharmaceutical/Biotech Experience
Reimbursement Knowledge
MS Office
Communication
Time Management
Verified Source
Posted 3 months ago
AR

Medical Affairs Operations, Business Project and Operations (BPO) Manager

argenxAnywhereFull-time
View Job
Compensation$90K - 130K a year

Lead financial operations, vendor management, and strategic projects for the US Medical Affairs & Evidence Generation department, ensuring budget compliance and operational efficiency. | Bachelor’s degree, 3+ years biopharma experience in medical affairs or strategic operations, strong financial acumen, project management skills, and vendor contract expertise. | Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. argenx is a biotechnology company committed to developing innovative treatments for diseases with high unmet needs. This role plays a pivotal part in shaping and evolving the US Medical Affairs & Evidence Generation (USMAEG) Operations while stewarding the department’s budget planning and tracking. The Business Project and Operations (BPO) manager will lead organizational transformation and cross-functional strategic projects, and will own end-to-end financial management: budget planning, forecasting and tracking; vendor contracting and Statement of Work (SOW) development; and procure-to-pay (P2P) activities—including PO and invoice processing and issue resolution—to ensure timely delivery, compliance, and value for USMAEG initiatives. Key Responsibilities Finance & Vendor Operations 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 P2P for USMAEG internal stakeholders: vendor onboarding, requisitions, PO creation/amendment, and invoice processing to policy and cycle-time targets. Develop, negotiate, and execute SOWs and change orders with vendors; define scope, deliverables, acceptance criteria, and milestone-based payment schedules in partnership with Legal and Procurement. Build dashboards and reports (e.g., Excel, Power BI) that provide real-time visibility into budget consumption, forecast accuracy, and vendor performance. Strategic Project Management & Transformation Design and execute high-impact, cross-functional programs aligned to USMAEG priorities; 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 that streamline operations and increase data quality and scalability. Coordinate stakeholder and vendor engagement to ensure alignment on objectives, deliverables, risks, and interdependencies. Cross-Functional Collaboration 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 reviews with leadership and governance bodies. Skills & Competencies Strong financial acumen with experience managing multi-million-dollar operating and project budgets and improving forecast accuracy. Advanced Excel skills and comfort with data visualization (Power BI or similar). Proven strategic project management and planning capability, including KPI design and benefits realization. Contracting and vendor management expertise, including SOW structuring, milestone-based payments, and change control. Excellent communication, collaboration, and stakeholder/vendor management; ability to influence across levels. Detail-oriented with strong organizational skills and proficiency with digital tools/AI to enhance decision-making. Education & Experience Bachelor’s degree in Finance, Accounting, Business, Science, or related field; advanced degree or certifications (CPA, MBA, PMP) preferred. 3+ years of biopharma experience in medical affairs, strategic operations, or business/financial operations. Demonstrated success leading cross-functional initiatives and delivering on-time, on-budget outcomes in a complex, matrixed environment. At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer. Before you submit your application, CV or any other personal details to us, please review our argenx Privacy Notice for Job Applicants to learn more about how argenx B.V. and its affiliates (“argenx”) will handle and protect your personal data. If you have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at privacy@argenx.com. If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at hr.us@argenx.com. Only inquiries related to an accommodation request will receive a response. argenx is a global immunology company dedicated to improving the lives of people suffering from severe autoimmune diseases. Through our rich pipeline of first-in-class therapies, led by VYVGART®, we are accelerating progress toward our bold 2030 vision: to reach 50,000 patients and transform the landscape of autoimmune treatment. Our innovation mission combines with meaningful work and endless opportunities for growth to create once-in-a-career experiences. argonauts work in locations around the globe including Belgium, Boston, Japan and Amsterdam. There's more to discover at argenx, where our passion inspires bold possibility. argenx honors the terms of our written agreements with the recruiting and staffing agencies that we retain and contract with to assist us with talent searches and other recruiting needs. Accordingly, all resumes and referrals that recruiting and staffing agencies proactively share with argenx that (i) were not solicited or requested by argenx’s internal Talent Acquisition team and (ii) were sent in the absence of a valid, written agreement between argenx and the firm, recruiter, or agency, may be pursued by argenx and are ineligible for payment of referral or other fees. We encourage you to be cautious of recruiting scams and fictious communications that pretend to be from argenx employees. These scams are designed by fraudsters to get personal information (e.g., social security numbers, bank account information, dates of birth), money or payments from job seekers as part of a “recruiting” process. argenx does not request financial information or money from job seekers. Legitimate emails from argenx employees end in “@argenx.com.” Fraudsters disguise themselves by using similar email addresses (e.g., @argenxhr.com, @argenxcareer.com, etc.) or public domains (@gmail.com, @yahoo.com, etc.). They may use photographs and names of real argenx employees for their fake interviews. argenx does not recruit or post positions on RingCentral, Facebook, or Craig’s List. Our formal recruitment process includes interviews with members of argenx’s talent acquisition team and other interviewers that occur in person at our offices, or via Zoom or Teams video calls. Interview processes that involve a formal offer from argenx will include written employment documentation on official argenx letterhead. argenx takes prompt appropriate and responsive action to fraudulent recruiting efforts when we become aware of them. If you believe you have been victimized by an employment application or a fraudulent recruiting scam, you can contact your local law enforcement authority for guidance or the FBI’s Internet Crimes Complaint Center at www.IC3.gov to file a complaint.

Financial management
Budget planning and forecasting
Vendor contracting and SOW development
Project management
Cross-functional collaboration
Excel and Power BI
Process improvement and automation
Direct Apply
Posted 3 months ago
argenx

Medical Affairs Operations Manager, Business Project and Operations, BPO

argenxAnywhereFull-time
View Job
Compensation$90K - 130K a year

Lead strategic projects and financial operations for US Medical Affairs, including budgeting, forecasting, vendor management, and cross-functional program execution. | Bachelor’s degree with 3+ years biopharma or related strategic operations experience, strong financial acumen, advanced Excel and data visualization skills, and contracting/vendor management expertise. | Description: • 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. Requirements: • Bachelor’s degree in Finance, Accounting, Business, Science, or related field; advanced degree or certifications (CPA, MBA, PMP) preferred. • 3+ years of biopharma experience in medical affairs, strategic operations, or business/financial operations. • Strong financial acumen with experience managing multi-million-dollar operating and project budgets and improving forecast accuracy. • Advanced Excel skills and comfort with data visualization (Power BI or similar). • Proven strategic project management and planning capability, including KPI design and benefits realization. • Contracting and vendor management expertise, including SOW structuring, milestone-based payments, and change control. • Excellent communication, collaboration, and stakeholder/vendor management; ability to influence across levels. • Detail-oriented with strong organizational skills and proficiency with digital tools/AI to enhance decision-making. Benefits:

Strategic project management
Budget management
Financial forecasting
Vendor and contract management
Excel and Power BI
Cross-functional leadership
Change management
KPI development
Verified Source
Posted 3 months ago
AR

Associate Director, Medical Writing

argenxAnywhereFull-time
View Job
Compensation$Not specified

The Associate Director of Medical Writing will be the primary author of various regulatory documents and will manage medical writers to ensure quality and consistency. This role also involves collaborating with project teams to meet deadlines and maintain inspection-readiness. | Candidates should have a Bachelor's degree in a scientific discipline, with a PhD preferred, and at least 5 years of relevant medical writing experience. Proficiency in American English and familiarity with eCTD writing and regulatory guidelines are essential. | Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. argenx is a clinical-stage biopharmaceutical company creating and developing a pipeline of differentiated antibody therapeutics. Our unique antibody engineering technologies combined with the complementary expertise of our people enabled us to build a clinical-stage portfolio of novel product candidates – tailored from discovery through development to address patient needs. For the expansion of our team, argenx is looking for an Associate Director of Medical Writing to contribute to the development of complex clinical, nonclinical, and safety documents for regulatory submissions. This individual will also develop critical infrastructure for the maturation of the department. This individual will contribute to and execute the overall strategy for all medical writing processes to according argenx medical writing standards standards and corporate objectives. Roles and Responsibilities: Primary author of phase 1-4 protocols, IBs, CSRs, master ICFs, eCTD modules for INDs and BLAs, briefing documents for scientific advice, specialty regulatory documents like PIPs, ODDs, aggregate reports, RFIs, and other documents required for drug development Engages relevant SMEs and document owners to develop content that is well-organized, consistent, accurate, and appropriate for a regulatory audience Responsible for inspection-readiness of medical writing activities Facilitates standardization of documents using document templates, lexicons, and argenx style guide to ensure the quality and consistency of documents across programs Manage medical writers (in-house FTEs, contractors, and external vendors) who are individually contributing to the MW activities for a variety of regulatory documents Collaborates with project teams, including program leader, clinical study managers, biostatisticians, and medical directors, to ensure project deadlines are met Responsible for inspection-readiness of medical writing activities 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 Desired Skills and Experience: Bachelor’s degree in a scientific or clinical discipline or related field required; PhD preferred Minimum of 5 years of related, sponsor-level pharma or biotech clinical/regulatory medical writing experience required; CRO experience considered Native/bilingual or fluent American English proficiency Solution-focused eCTD Module 5 and Module 2 writing experience for global MAAs Basic understanding of scientific methodology as applied to drug development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission Knowledgeable in the regulatory guidances developed for documents authored by medical writing Ability to proofread documents for compliance with internal and external guidance documents Ability to approach issues from various perspectives and accurately summarize data to provide conclusions Ability to work precisely according to procedures and regulations Excellent written and verbal communication skills Ability to prioritize and multi-task successfully in a fast-paced environment Ability to work autonomously, as well as collaboratively in a team Excellent time management skills and a proven ability to work on multiple projects at any given time Must be proficient in MS Office Familiarity with Veeva Vault and Please Review preferred Familiarity with pharmacovigilance documents preferred ** Strong preference for individuals located on the East Coast** #LI-Remote At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer. Before you submit your application, CV or any other personal details to us, please review our argenx Privacy Notice for Job Applicants to learn more about how argenx B.V. and its affiliates (“argenx”) will handle and protect your personal data. If you have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at privacy@argenx.com. If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at hr.us@argenx.com. Only inquiries related to an accommodation request will receive a response. argenx is a global immunology company dedicated to improving the lives of people suffering from severe autoimmune diseases. Through our rich pipeline of first-in-class therapies, led by VYVGART®, we are accelerating progress toward our bold 2030 vision: to reach 50,000 patients and transform the landscape of autoimmune treatment. Our innovation mission combines with meaningful work and endless opportunities for growth to create once-in-a-career experiences. argonauts work in locations around the globe including Belgium, Boston, Japan and Amsterdam. There's more to discover at argenx, where our passion inspires bold possibility. argenx honors the terms of our written agreements with the recruiting and staffing agencies that we retain and contract with to assist us with talent searches and other recruiting needs. Accordingly, all resumes and referrals that recruiting and staffing agencies proactively share with argenx that (i) were not solicited or requested by argenx’s internal Talent Acquisition team and (ii) were sent in the absence of a valid, written agreement between argenx and the firm, recruiter, or agency, may be pursued by argenx and are ineligible for payment of referral or other fees. We encourage you to be cautious of recruiting scams and fictious communications that pretend to be from argenx employees. These scams are designed by fraudsters to get personal information (e.g., social security numbers, bank account information, dates of birth), money or payments from job seekers as part of a “recruiting” process. argenx does not request financial information or money from job seekers. Legitimate emails from argenx employees end in “@argenx.com.” Fraudsters disguise themselves by using similar email addresses (e.g., @argenxhr.com, @argenxcareer.com, etc.) or public domains (@gmail.com, @yahoo.com, etc.). They may use photographs and names of real argenx employees for their fake interviews. argenx does not recruit or post positions on RingCentral, Facebook, or Craig’s List. Our formal recruitment process includes interviews with members of argenx’s talent acquisition team and other interviewers that occur in person at our offices, or via Zoom or Teams video calls. Interview processes that involve a formal offer from argenx will include written employment documentation on official argenx letterhead. argenx takes prompt appropriate and responsive action to fraudulent recruiting efforts when we become aware of them. If you believe you have been victimized by an employment application or a fraudulent recruiting scam, you can contact your local law enforcement authority for guidance or the FBI’s Internet Crimes Complaint Center at www.IC3.gov to file a complaint.

Medical Writing
Regulatory Submissions
Clinical Development
Document Standardization
Project Management
Collaboration
Scientific Methodology
Proofreading
Time Management
MS Office
eCTD Writing
Pharmacovigilance
Communication
Multi-tasking
Autonomy
Teamwork
Direct Apply
Posted 3 months ago

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