Promotional Review Committee Coordinator
DBV Technologies
4 months ago
Remote friendly (Warren, NJ)
United States
Marketing
Key Responsibilities
- Intake & Triage: Review incoming jobs for completeness; verify correct tactic type, audience, lifecycle state, and required references/claims documentation.
- Metadata & Quality Checks: Ensure required metadata fields (e.g., product, audience, channel, campaign, fair balance/ISI references) are complete and accurate prior to routing; perform version control checks and label alignment.
- Routing & Workflow Management: Route materials to appropriate PRC reviewers (Medical, Regulatory, Legal; plus other SMEs as needed) via Veeva Vault PromoMats; monitor review cycles and escalate bottlenecks.
- Meeting Operations: Plan, schedule, and facilitate PRC meetings; build and circulate agendas; assemble annotated materials and reference packs; capture comments, decisions, and next steps; ensure timely incorporation of feedback.
- Lifecycle Tracking: Track progress, approvals, version histories, re-approvals, renewals, and expiry dates; initiate re-review cycles triggered by label updates or market-specific requirements.
- Stakeholder Communication: Provide regular status updates to brand teams, agencies, and reviewers; manage expectations during peak volume; coordinate expedited reviews when needed.
- Systems & Data Stewardship: Maintain audit-ready documentation in PromoMats; uphold SOPs and business rules; support user training, access requests, role assignments, and minor configuration requests.
Qualifications
- 1–2+ years coordinating PRC processes in pharma/biotech, medical devices, or healthcare marketing operations.
- Hands-on experience with Veeva Vault PromoMats (submission workflows, routing, annotations, versioning, permissions).
- Strong understanding of US FDA advertising and promotion principles (fair balance, on-label claims, ISI).
- Ability to manage multiple concurrent submissions and deadlines in a fast-paced environment.
- Excellent organization, communication, stakeholder management; confident meeting facilitation and note capture.
- High attention to detail and a quality-check mindset; comfort with metadata, taxonomies, and audit readiness.
Knowledge/Skills/Abilities
- Veeva Vault PromoMats: job creation, metadata tagging, routing, annotations, redlines, reference linking, version control, lifecycle states, reporting.
- PRC meeting facilitation: agenda building, time management, capturing decisions/actions, driving to consensus.
- Regulatory/compliance awareness: alignment to approved labeling; OPDP considerations; market-specific rules (e.g., managed access rules).
- Document quality: proofing, consistency checks, reviewer-ready materials.
- Project management and prioritization; risk escalation; stakeholder updates.
- Tools: Microsoft 365 (Teams, Outlook, Excel/SharePoint), Adobe Acrobat, and common agency file formats.
- Intake & Triage: Review incoming jobs for completeness; verify correct tactic type, audience, lifecycle state, and required references/claims documentation.
- Metadata & Quality Checks: Ensure required metadata fields (e.g., product, audience, channel, campaign, fair balance/ISI references) are complete and accurate prior to routing; perform version control checks and label alignment.
- Routing & Workflow Management: Route materials to appropriate PRC reviewers (Medical, Regulatory, Legal; plus other SMEs as needed) via Veeva Vault PromoMats; monitor review cycles and escalate bottlenecks.
- Meeting Operations: Plan, schedule, and facilitate PRC meetings; build and circulate agendas; assemble annotated materials and reference packs; capture comments, decisions, and next steps; ensure timely incorporation of feedback.
- Lifecycle Tracking: Track progress, approvals, version histories, re-approvals, renewals, and expiry dates; initiate re-review cycles triggered by label updates or market-specific requirements.
- Stakeholder Communication: Provide regular status updates to brand teams, agencies, and reviewers; manage expectations during peak volume; coordinate expedited reviews when needed.
- Systems & Data Stewardship: Maintain audit-ready documentation in PromoMats; uphold SOPs and business rules; support user training, access requests, role assignments, and minor configuration requests.
Qualifications
- 1–2+ years coordinating PRC processes in pharma/biotech, medical devices, or healthcare marketing operations.
- Hands-on experience with Veeva Vault PromoMats (submission workflows, routing, annotations, versioning, permissions).
- Strong understanding of US FDA advertising and promotion principles (fair balance, on-label claims, ISI).
- Ability to manage multiple concurrent submissions and deadlines in a fast-paced environment.
- Excellent organization, communication, stakeholder management; confident meeting facilitation and note capture.
- High attention to detail and a quality-check mindset; comfort with metadata, taxonomies, and audit readiness.
Knowledge/Skills/Abilities
- Veeva Vault PromoMats: job creation, metadata tagging, routing, annotations, redlines, reference linking, version control, lifecycle states, reporting.
- PRC meeting facilitation: agenda building, time management, capturing decisions/actions, driving to consensus.
- Regulatory/compliance awareness: alignment to approved labeling; OPDP considerations; market-specific rules (e.g., managed access rules).
- Document quality: proofing, consistency checks, reviewer-ready materials.
- Project management and prioritization; risk escalation; stakeholder updates.
- Tools: Microsoft 365 (Teams, Outlook, Excel/SharePoint), Adobe Acrobat, and common agency file formats.