Global Program & Project Management

BiggsB has delivered global project management engagements for Roche, Pfizer and GSK.

A regulated initiative spans functions, sites or countries, and no single structure owns the plan, the decisions and the reporting. Leadership needs one accountable program that shows what is happening, what is at risk and who decides.

• -Pharmaceutical and biotech companies running global or cross-functional initiatives
• -Regulatory, quality and operations leaders responsible for a complex regulated program
• -Organizations establishing a PMO or strengthening an existing one
• -Leadership teams that need consistent reporting across several programs

• -A regulated initiative involves several functions, sites or countries
• -Several programs compete for the same people and budget
• -A PMO needs to be established, or its governance is not working
• -Leadership does not have a reliable view of progress and risk

• -Strategic program oversight for complex regulated initiatives
• -Global project management across functions, sites and countries
• -Portfolio optimization: prioritizing programs against capacity and objectives
• -PMO establishment and governance
• -Performance management: measures and reporting for leadership

• -Program structure with roles and decision rights
• -Integrated program plan with milestones and owners
• -PMO operating model and governance cadence
• -Portfolio view with agreed priorities
• -Performance measures and leadership reporting

1. 01Understand. Confirm the objectives, stakeholders, constraints and current state of the program or portfolio.
2. 02Structure. Set up the program structure, governance and decision rights, or strengthen the PMO already in place.
3. 03Run. Manage the plan with your teams, track performance and bring issues to the right decision makers.
4. 04Hand over. Leave governance, plans and reporting your organization can run without us.

• Global Regulatory Advisory — Market-entry, submission and remediation work across several markets can be run as one program with a shared plan and decision log.
• Computer System Validation & Computer Software Assurance — Validation programs for new or upgraded GxP systems can be planned, tracked and reported within program governance.
• Mergers & Acquisitions in Regulated Industries — Post-acquisition integration of regulated operations, quality systems and computerized systems can be governed as an integration program.

Each engagement is led by a senior BiggsB practitioner with experience of the relevant regulatory framework, supported by specialists from the supporting capabilities as the scope requires.

BiggsB manages and supports the program; budgets, decision rights and regulatory commitments remain with your organization. The client engagements named on this page were global project management engagements and do not describe every service BiggsB offers.

Which organizations has BiggsB delivered global project management for?

BiggsB has delivered global project management engagements for Roche, Pfizer and GSK. Client-specific scope and results are not published.

Can BiggsB set up or strengthen a PMO?

Yes. PMO establishment and governance is part of this capability: the operating model, governance cadence, roles and the reporting leadership relies on.

How is a program management engagement scoped?

We start with a conversation about the initiative, its stakeholders and its timeline. Objectives, deliverables, roles and decision rights are then agreed in writing before work starts.

• Global Regulatory Advisory — global-regulatory
• Computer System Validation & Computer Software Assurance — compliance-validation
• Mergers & Acquisitions in Regulated Industries — mergers-acquisitions

Use the inquiry form, email connect@biggsb.com, or book a call.

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