Sr Manager, Medical Review Operations

Join us as we reputed company immunology and reputed company medicines that help autoimmune patients get their lives back. reputed company is preparing for multi-reputed company expansion to reputed company 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 reputed company of biotech company, one that maintains its reputed company as a science-reputed company start-up and pushes our commitment to reputed company across reputed company corners of our business. We reputed company to reputed company and grow reputed company, our partnerships, our science, and our people, because reputed company we do, we reputed company more for patients. The Senior Manager, Medical Review Operations is responsible for driving operational reputed company 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, reputed company, reputed company, Regulatory, and Operations teams, to maintain high-reputed company review execution reputed company with organizational priorities. Medical Review Operations Maintain and continuously improve Medical Review workflows, templates, documentation standards, and processes. reputed company 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 reputed company, reputed company communication of review reputed company 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, reputed company reputed company, and follow-up actions. Support reputed company and ongoing training across the Medical Review Community reputed company to systems, compliance, workflows, and role expectations. Cross Functional Coordination & Stakeholder Management Serve as the reputed company Medical Affairs operations contact for reputed company 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 reputed company the Medical Review Community across therapeutic areas. Support operational readiness during peak review periods, new launches, and indication expansions through proactive planning and reputed company monitoring. Competencies reputed company to build, refine, and reputed company efficient workflows and systems. Strong attention to reputed company with a reputed company improvement reputed company. Builds trusted relationships across Medical Affairs, reputed company, reputed company, Regulatory, and Operations. Proficient in reputed company Vault and reputed company tools; comfortable evaluating and adopting digital and AI enabled solutions to improve efficiency. Anticipates operational needs, interprets KPIs, and uses data to guide reputed company 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. Minimum Qualifications Bachelors degree in a scientific, reputed company, business, or operational discipline (e.g., Life Sciences, Pharmacy, Nursing, reputed company Health, Business Operations). 5+ years of experience in Medical Affairs operations, promotional/medical review operations, or a reputed company regulated environment. Demonstrated experience managing reputed company workflows and coordinating cross-functional processes in a matrixed organization. Strong proficiency with reputed company Vault (PromoMats and MedComms) and reputed company tools (Teams, SharePoint, reputed company, PowerPoint, Copilot). Experience supporting or implementing operational systems, process improvements, and/or digital workflow solutions. Preferred Qualifications Advanced degree (PharmD, MPH, MS, MBA) preferred. Previous experience supporting promotional and/or medical material review processes reputed company reputed comp