In early 2025, GSK’s global regulatory project management office (PMO) led by Director Rahman Ahrar piloted an enhanced project-management framework using Smartsheet to streamline and standardize regulatory submission workflows across multiple global markets. Their core challenge was managing regulatory filings for new HIV, oncology, and infectious‑disease treatments simultaneously across multiple jurisdictions posed coordination, transparency, and timing challenges. The need to balance confidentiality with cross-team visibility was especially demanding. This blog article highlights some interesting aspects of the enhancements as drawn from public statements and write ups.
🔍 PM Enhancements & Innovative Practices
Unified Dashboards + Real‑Time Tracking
Centralized views of every submission’s stage, progress, and blocker status enhanced transparency and oversight.Automated Workflows
Notifications, reminders, and escalations triggered automatically reducing manual follow-up and attention to detail errors.Selective Data Sharing Modules
Tools like Smartsheet’s Dynamic View and Control Center enabled secure, filtered access for external stakeholders (consultants, CROs) without exposing full project details.Seamless Financial Coordination
Smartsheet’s Data Shuttle linked budget and expense data with GSK’s ERP, enabling real‑time budget tracking tied directly to regulatory activities.External Partner Collaboration
GSK onboarded four consulting firms onto the same platform in an 18‑week intensive rollout during COVID‑19—demonstrating ease of adoption, speed, and efficiency.
Lessons & Takeaways for Biotech PMs
Practice | Benefit |
---|---|
Central PM Tool Adoption | Reduces siloed data; establishes single source of truth. |
Automated Notifications | Mitigates timeline drift and manual follow-up. |
Controlled External Access | Enhances collaboration securely without jeopardizing confidentiality. |
Integration with Financial Systems | Ties project activities to cost control—improves forecasting and accountability. |
Scalable Rollouts with Stakeholders | Demonstrates platform adaptability and cultivates trust early. |
Why This Is Broader Than GSK
Regulated Industries—including biotech, medtech, and pharma can adopt this digital PMO model to manage regulated product submissions and compliance projects.
Platform Selection Matters—choose PM tools that not only handle tasks but also integrate data streams, control access layers, and automate workflows.
Process Repeatability—a systemized, codified PMO approach scales better than one-off solutions.
In summary
GSK’s PMO story shows that modern project‑management platforms such as Smartsheets, when thoughtfully configured (automation + dynamic access + financial linkages), can transform complex regulatory projects into efficient, scalable operations. For biotech teams managing cross-functional, multi-region submissions, this model provides an actionable blueprint with both technological and organizational enhancements.
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