Supporting capability
Global Program & Project Management
BiggsB provides program and project management for complex initiatives in regulated industries: strategic program oversight, portfolio optimization, establishing and governing a program management office (PMO), and performance management that gives leadership a reliable view of progress.
Speak with an advisorSelected pharmaceutical experience
BiggsB has delivered global project management engagements for Roche, Pfizer and GSK.
The client situation
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.
Who this is for
- 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
When clients call us
- 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
Scope
- 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
Deliverables
- 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
Engagement approach
- Step 1
Understand
Confirm the objectives, stakeholders, constraints and current state of the program or portfolio.
- Step 2
Structure
Set up the program structure, governance and decision rights, or strengthen the PMO already in place.
- Step 3
Run
Manage the plan with your teams, track performance and bring issues to the right decision makers.
- Step 4
Hand over
Leave governance, plans and reporting your organization can run without us.
Service boundaries. 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.
How this connects to other work
- Global Regulatory AdvisoryMarket-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 AssuranceValidation programs for new or upgraded GxP systems can be planned, tracked and reported within program governance.
- Mergers & Acquisitions in Regulated IndustriesPost-acquisition integration of regulated operations, quality systems and computerized systems can be governed as an integration program.
Responsible expertise
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.
Questions about Program & Project Management
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.
Speak with an advisor about Program & Project Management
Describe the decision or project in front of you. Your inquiry goes to the advisor team for the service you choose.