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Sr Manager, Medical Review Operations
REQ-4226 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 Senior Manager, Medical Review Operations is responsible for driving operational excellence and strengthening community coordination and cross-functional collaboration across Medical Affairs and the US Medical Review Community. This role ensures efficient communication, effective coordination and workflows, optimized systems and processes, and the implementation of digital and automation tools. As a key operational partner, the Senior Manager works closely with Medical Reviewers along with Medical Affairs, Commercial, Legal, Regulatory, and Operations teams, to maintain high-quality review execution aligned with organizational priorities. Medical Review Operations
- Maintain and continuously improve Medical Review workflows, templates, documentation standards, and processes.
- Curate and maintain community resources such as playbooks, reference libraries, the Medical Review Hub, and data on file (DOF) management.
- Coordinate inter-team scheduling and manage the Medical Review team calendar to ensure appropriate reviewer coverage.
- Facilitate timely, clear communication of review decisions to relevant stakeholders and ensure documentation aligns with governance expectations.
- Monitor timelines and operational key performance indicators (KPIs); proactively identify bottlenecks, anticipate needs, and proactively implement process improvements.
- Plan and execute Medical Review Community meetings and capability-building sessions, including scheduling, agenda development, quorum oversight, and follow-up actions.
- Support onboarding and ongoing training across the Medical Review Community related to systems, compliance, workflows, and role expectations.
- Serve as the primary Medical Affairs operations contact for Commercial Operations to support project prioritization, forecasting, and alignment with strategic priorities.
- Partner with Medical Review sub-team leads and the review team to harmonize processes and best practices within the Medical Review Community across therapeutic areas.
- Support operational readiness during peak review periods, new launches, and indication expansions through proactive planning and capacity monitoring.
- Able to build, refine, and scale efficient workflows and systems.
- Strong attention to detail with a continuous improvement mindset.
- Builds trusted relationships across Medical Affairs, Commercial, Legal, Regulatory, and Operations.
- Proficient in Veeva Vault and Microsoft tools; comfortable evaluating and adopting digital and AI enabled solutions to improve efficiency.
- Anticipates operational needs, interprets KPIs, and uses data to guide decisions and prioritize resources.
- Thrives in dynamic, fast paced contexts; responds effectively to shifting priorities, volume peaks, and evolving processes.
- Supports capability-building across the Medical Review Community and ensures consistent standards, tools, and resources.
- Bachelor’s degree in a scientific, healthcare, business, or operational discipline (e.g., Life Sciences, Pharmacy, Nursing, Public Health, Business Operations).
- 5+ years of experience in Medical Affairs operations, promotional/medical review operations, or a related regulated environment.
- Demonstrated experience managing complex workflows and coordinating cross-functional processes in a matrixed organization.
- Strong proficiency with Veeva Vault (PromoMats and MedComms) and Microsoft tools (Teams, SharePoint, Excel, PowerPoint, Copilot).
- Experience supporting or implementing operational systems, process improvements, and/or digital workflow solutions.
- Advanced degree (PharmD, MPH, MS, MBA) preferred.
- Previous experience supporting promotional and/or medical material review processes within pharma.
- Experience with AI enabled tools, automation platforms, or digital transformation initiatives.
- Familiarity with Medical Affairs functions, and how it relates to reference management, and evidence standards.
- Strong project management capability, with the ability to prioritize, plan, and execute across multiple competing deadlines.
- Excellent written and verbal communication skills across cross functional teams.
- Strong analytical ability, including interpreting KPIs and using data for decision making.
- Proven ability to build relationships, influence without authority, and foster collaborative problem solving.
- High level of organization, attention to detail, and operational discipline.
- Ability to thrive in a dynamic, fast paced environment with evolving priorities.
