Sr Manager, Medical Review Operations

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. 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.

Requirements

• 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.

Benefits

• Short-term and long-term incentive programs
• Comprehensive benefits package
• Retirement savings plans
• Health benefits
• Generous Paid Time Off