Manager, PRC Coordinator, Promotional Review & Operations Boston, MA (US)
We are seeking a Manager, PRC Coordinator, Promotional Review & Operations (PRO) to lead the end-to-end performance of the promotional review portfolio across assigned therapeutic areas and business priorities.
This role integrates portfolio planning, submission readiness, workflow orchestration, launch execution, stakeholder alignment, lifecycle management, performance monitoring, and continuous improvement, all while maintaining compliance with applicable policies, SOPs, and the US PRC Operations Manual.
This is not a meeting-administration role. You will exercise sound judgment, lead cross-functional operating rhythms, challenge avoidable defects and delays, and translate portfolio signals into clear actions, owners, dates, escalations, and measurable improvement.
Responsibilities
Strategic Portfolio Leadership Integrated operating view: Own the operating view for assigned portfolios, including launch, campaign, reapproval, expiration, and business-as-usual demand, maintaining an integrated plan of priorities, dependencies, owners, and dates.
Risk anticipation: Use demand, aging, quality, capacity, and workflow signals to identify emerging risks, recommend sequencing, and escalate decisions when launch and business-as-usual priorities compete.
Planning & Prioritization forums: Prepare and facilitate forums that convert forecasts and business priorities into executable review plans and clearly documented commitments.
Cross-functional partnership: Partner with Commercial, Medical, Regulatory, Legal, Compliance, Business Operations, agencies, vendors, and PRO leaders to align expectations and sustain decision continuity.
End-to-End PRC Operations & Governance Full-cycle coordination: Coordinate intake, readiness, routing, review cycles, PRC and ad hoc meetings, decision and action documentation, final-upload verification, approved-release handoffs, reapproval, expiration alerts, and withdrawal follow-up.
Workflow compliance: Ensure materials are routed through the correct workflow, are review-ready, and meet applicable requirements, policies, SOPs, and operating standards.
Audit-ready records: Maintain accurate agendas, annotations, status communications, decisions, actions, and records, following up through documented closure.
Escalation pathways: Initiate and support approved escalation pathways, including ERC escalation when applicable, and document final decisions and required follow-through.
Submission Excellence Program Leadership Readiness checklists: Apply approved intake and readiness checklists to identify missing references, metadata, annotations, support, or other package defects before review.
Defect documentation: Consistently document rejection, rework, and defect reasons; distinguish coordinator checks from specialist or reviewer judgment and route questions to the appropriate owner.
Trend analysis: Use monthly and in-cycle signals to identify repeat defects and material trends, without deferring urgent risk action while awaiting formal reports.
Documented interventions: Lead interventions with Project Owners and agencies using specific examples, agreed corrective actions, accountable owners, due dates, and effectiveness checks.
Sustained improvement: Monitor improvement in subsequent cycles, escalate overdue or recurring issues, and contribute to Submission Excellence training, job aids, and operating standards.
Launch Readiness & Priority Execution Launch planning: Partner with launch leads and business stakeholders to establish review forecasts, priority order, reviewer commitments, meeting cadence, dependencies, and contingency coverage for launch-critical materials.
Capacity management: Anticipate volume surges and timing conflicts, surface capacity constraints early, and recommend practical mitigation plans.
Operational balance: Maintain disciplined launch execution while protecting business-as-usual continuity and keeping risks,…