Manager, Promotional Review and Operations

Strategic Portfolio Leadership

• 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.
• 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.
• Prepare and facilitate forums that convert forecasts and business priorities into executable review plans and clearly documented commitments.
• 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

• 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.
• Ensure materials are routed through the correct workflow, are review-ready, and meet applicable requirements, policies, SOPs, and operating standards.
• Maintain accurate agendas, annotations, status communications, decisions, actions, and records, following up through documented closure.
• Initiate and support approved escalation pathways, including ERC escalation when applicable, and document final decisions and required follow-through.

Submission Excellence Program Leadership

• Apply approved intake and readiness checklists to identify missing references, metadata, annotations, support, or other package defects before review.
• Consistently document rejection, rework, and defect reasons; distinguish coordinator checks from specialist or reviewer judgment and route questions to the appropriate owner.
• Use monthly and in-cycle signals to identify repeat defects and material trends, without deferring urgent risk action while awaiting formal reports.
• Lead interventions with Project Owners and agencies using specific examples, agreed corrective actions, accountable owners, due dates, and effectiveness checks.
• 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

• 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.
• Anticipate volume surges and timing conflicts, surface capacity constraints early, and recommend practical mitigation plans.
• Maintain disciplined launch execution while protecting business-as-usual continuity and keeping risks, decisions, and recovery actions visible.

Performance, Aging & Continuous Improvement

• Monitor volume, cycle time, aging, review readiness, quality, rework, and recurring defects, and translate findings into targeted actions.
• Intervene on aging materials at defined checkpoints, documenting the blocker, next action, owner, and resolution date, and escalating material risk before timelines are exceeded.
• Identify and lead process, system, meeting, and operating-model improvements in partnership with PRO Process, Systems, Lifecycle, and Analytics colleagues.
• Support root-cause analysis, CAPA/deviation evidence collection, corrective-action tracking, and effectiveness checks when required.

Stakeholder, Agency & Vendor Management

• Serve as the primary coordination point for assigned portfolios, communicating priorities, accountabilities, risks, and decisions clearly and promptly.
• Hold Project Owners, agencies, and vendors to approved readiness, workflow, quality, and follow-through expectations while maintaining constructive relationships.
• Support onboarding and training of stakeholders on PRC processes, policies, SOPs, systems, and role responsibilities.
• Coordinate with service providers and backup resources to maintain coverage and continuity, and flag scope, capacity, or service-standard concerns to PRO leadership.

Systems, Data Integrity & Knowledge Management

• Maintain accurate records, metadata, ownership, distribution lists, rosters, calendars, templates, and portfolio documentation in approved systems and repositories.
• Support system enhancements, user acceptance testing, adoption, and change communications relevant to coordinator workflows.
• Protect audit traceability and ensure operating documents, decisions, and handoffs are accessible, current, and sustainable during transitions.

Leadership & Team Contribution

• Model critical thinking, responsiveness, and escalation discipline; operate independently with sound judgment and minimal oversight.
• Provide backup coverage, share portfolio knowledge, and support standardized coordinator practices across the broader PRO organization.
• Coach newer coordinators and contribute practical scenarios, playbooks, and lessons learned to coordinator qualification and continuous learning.

Decision Rights & Accountability

• Makes day-to-day coordination, sequencing, and escalation recommendations within approved PRC governance and portfolio priorities.
• Owns operational follow-through and evidence; specialist medical, legal, regulatory, compliance, commercial, and contractual decisions remain with the authorized functional owners.
• Escalates unresolved risk, conflicting priorities, recurring quality issues, and material capacity gaps with supporting facts and a recommended path forward.