argenx
Senior Manager, Professional Relations Independent Medical Education (PRIME) and
argenx, Phila, Pennsylvania, United States
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 seeking a highly organized and detail-oriented
Senior Manager
to lead and optimize the operational, compliance, and governance processes for
Independent Medical Education (IME) grants, Medical Affairs‑led Sponsorships
and
Medical Review Operations . This role is pivotal in ensuring strategic alignment, regulatory compliance, and operational excellence across neuroscience, immunology and other therapeutic areas. The ideal candidate will bring deep expertise in Medical Affairs operations, grant and sponsorship management, and cross‑functional collaboration within a regulated environment.
Key Responsibilities Grants & Sponsorship Operations
Manage the full lifecycle of IME grants and Medical Affairs‑led sponsorships, including intake, triage, compliance review, approvals, contracting, and reconciliation.
Serve as operational lead and facilitator for formal review sessions (e.g., Grant Review Committee [GRC]), ensuring timely reviews, quorum management, and documentation of decisions.
Coordinate submission reviews across U.S., and International Medical Affairs teams, adhering to defined timelines and governance standards.
Partner with cross‑functional stakeholders (Legal, Compliance, Finance, Medical Strategy) to ensure strategic alignment and transparency in funding decisions.
Maintain a schedule of supported educational events and track outcomes across indications and molecules.
Systems & Compliance Oversight
Monitor and manage submissions using electronic platforms (e.g., Veeva Vault PromoMats, Veeva Vault MedComms, Iqvia)
Ensure accurate classification of grants (e.g., accredited vs. non‑accredited), completion of due diligence (e.g., debarment screenings), and documentation of decisions.
Collaborate with Legal to finalize Letters of Agreement (LOAs), Statement of Work (SOW) and amendments.
Oversee program delivery to ensure evidence‑based, fair, and balanced content in accordance with policy guidelines.
Lead reconciliation efforts post‑event, confirming proper fund usage, metrics reporting, and return of unused funds.
Strategic Planning & Reporting
Contribute to annual strategic planning, including therapeutic area needs assessments, budget forecasting, and development of areas of interest.
Develop and maintain standardized templates, checklists, and SOPs to drive consistency and efficiency.
Analyze portfolio metrics to identify trends, gaps, and opportunities for process improvement.
Ensure audit readiness and compliance with transparency reporting requirements.
Cross‑Functional Collaboration & Continuous Improvement
Identify and implement process improvements related to IME and sponsorship workflows.
Update documentation and workflow diagrams to support business continuity and operational excellence.
Respond to reported issues and collaborate with internal and external stakeholders to resolve them.
Partner with the IME Director and other leaders on strategic initiatives and special projects.
Medical Review Operations
Coordinate inter‑team scheduling across multiple inputs to ensure consistent coverage for project reviews. Maintain and optimize the Medical Review team calendar to support operational efficiency.
Facilitate clear and timely communication of decisions across Medical Review sub‑teams. Ensure documentation of outcomes and alignment with governance processes.
Serve as the primary Medical Affairs contact for Marketing and Material Review Committee Operations to support project prioritization, forecasting, and strategic alignment.
Lead enhancements to Veeva Vault workflows and develop associated process documentation to support scalable and compliant review operations. Experience with Microsoft tools and Artificial Intelligence‑enabled platforms is preferred to drive automation and efficiency.
Manage administrative tasks related to quarterly Medical Review Community Meetings, including scheduling, agenda coordination, and follow‑up actions.
Qualifications Education & Experience
Bachelor’s degree in Life Sciences, Business Administration, or related field (advanced degree preferred).
Minimum 3–5 years of experience in Medical Affairs operations, medical education, or grants/sponsorship management in the pharmaceutical/biotech or healthcare industry. Experience in operational support of medical material review is desirable.
Technical Skills
Proficiency in Microsoft 365 (Excel, PowerPoint, Word, Outlook); advanced Excel skills (Pivot Tables, Macros, VBA) preferred.
Experience with Microsoft tools related to artificial intelligence (AI) and familiarity with integrating AI capabilities into operational workflows.
Experience with grant management systems (e.g., CyberGrants, Iqvia).
Familiarity with reporting tools (e.g., SmartSheets, Mondays.com).
Experience with Veeva Vault PromoMats and Veeva Vault MedComms.
Knowledge & Competencies
Deep understanding of IME, CME, and third‑party sponsorship standards, including U.S. and ex‑U.S. compliance regulations (e.g., Sunshine Act, EFPIA, OIG, PhRMA, ACCME).
Strong project management, facilitation, and documentation skills.
Ability to work independently and manage multiple priorities in a fast‑paced, regulated environment.
Experience coordinating across matrixed global teams and managing external education providers.
Additional Information
Occasional travel.
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.
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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 seeking a highly organized and detail-oriented
Senior Manager
to lead and optimize the operational, compliance, and governance processes for
Independent Medical Education (IME) grants, Medical Affairs‑led Sponsorships
and
Medical Review Operations . This role is pivotal in ensuring strategic alignment, regulatory compliance, and operational excellence across neuroscience, immunology and other therapeutic areas. The ideal candidate will bring deep expertise in Medical Affairs operations, grant and sponsorship management, and cross‑functional collaboration within a regulated environment.
Key Responsibilities Grants & Sponsorship Operations
Manage the full lifecycle of IME grants and Medical Affairs‑led sponsorships, including intake, triage, compliance review, approvals, contracting, and reconciliation.
Serve as operational lead and facilitator for formal review sessions (e.g., Grant Review Committee [GRC]), ensuring timely reviews, quorum management, and documentation of decisions.
Coordinate submission reviews across U.S., and International Medical Affairs teams, adhering to defined timelines and governance standards.
Partner with cross‑functional stakeholders (Legal, Compliance, Finance, Medical Strategy) to ensure strategic alignment and transparency in funding decisions.
Maintain a schedule of supported educational events and track outcomes across indications and molecules.
Systems & Compliance Oversight
Monitor and manage submissions using electronic platforms (e.g., Veeva Vault PromoMats, Veeva Vault MedComms, Iqvia)
Ensure accurate classification of grants (e.g., accredited vs. non‑accredited), completion of due diligence (e.g., debarment screenings), and documentation of decisions.
Collaborate with Legal to finalize Letters of Agreement (LOAs), Statement of Work (SOW) and amendments.
Oversee program delivery to ensure evidence‑based, fair, and balanced content in accordance with policy guidelines.
Lead reconciliation efforts post‑event, confirming proper fund usage, metrics reporting, and return of unused funds.
Strategic Planning & Reporting
Contribute to annual strategic planning, including therapeutic area needs assessments, budget forecasting, and development of areas of interest.
Develop and maintain standardized templates, checklists, and SOPs to drive consistency and efficiency.
Analyze portfolio metrics to identify trends, gaps, and opportunities for process improvement.
Ensure audit readiness and compliance with transparency reporting requirements.
Cross‑Functional Collaboration & Continuous Improvement
Identify and implement process improvements related to IME and sponsorship workflows.
Update documentation and workflow diagrams to support business continuity and operational excellence.
Respond to reported issues and collaborate with internal and external stakeholders to resolve them.
Partner with the IME Director and other leaders on strategic initiatives and special projects.
Medical Review Operations
Coordinate inter‑team scheduling across multiple inputs to ensure consistent coverage for project reviews. Maintain and optimize the Medical Review team calendar to support operational efficiency.
Facilitate clear and timely communication of decisions across Medical Review sub‑teams. Ensure documentation of outcomes and alignment with governance processes.
Serve as the primary Medical Affairs contact for Marketing and Material Review Committee Operations to support project prioritization, forecasting, and strategic alignment.
Lead enhancements to Veeva Vault workflows and develop associated process documentation to support scalable and compliant review operations. Experience with Microsoft tools and Artificial Intelligence‑enabled platforms is preferred to drive automation and efficiency.
Manage administrative tasks related to quarterly Medical Review Community Meetings, including scheduling, agenda coordination, and follow‑up actions.
Qualifications Education & Experience
Bachelor’s degree in Life Sciences, Business Administration, or related field (advanced degree preferred).
Minimum 3–5 years of experience in Medical Affairs operations, medical education, or grants/sponsorship management in the pharmaceutical/biotech or healthcare industry. Experience in operational support of medical material review is desirable.
Technical Skills
Proficiency in Microsoft 365 (Excel, PowerPoint, Word, Outlook); advanced Excel skills (Pivot Tables, Macros, VBA) preferred.
Experience with Microsoft tools related to artificial intelligence (AI) and familiarity with integrating AI capabilities into operational workflows.
Experience with grant management systems (e.g., CyberGrants, Iqvia).
Familiarity with reporting tools (e.g., SmartSheets, Mondays.com).
Experience with Veeva Vault PromoMats and Veeva Vault MedComms.
Knowledge & Competencies
Deep understanding of IME, CME, and third‑party sponsorship standards, including U.S. and ex‑U.S. compliance regulations (e.g., Sunshine Act, EFPIA, OIG, PhRMA, ACCME).
Strong project management, facilitation, and documentation skills.
Ability to work independently and manage multiple priorities in a fast‑paced, regulated environment.
Experience coordinating across matrixed global teams and managing external education providers.
Additional Information
Occasional travel.
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.
#J-18808-Ljbffr