QS) 680 7-1 Final Project Milestone Three

Project Scope Statement

Project Title: Value-Driven Project and Portfolio Management in the Pharmaceutical Industry

I. Introduction

The focus of this project is to implement a value-driven Project and Portfolio Management (PPM) system within PharmaAdvance Inc. to enhance the alignment of Research and Development (R&D) and operational projects with strategic business objectives. It will include the adoption of PPM tools, development of governance frameworks, training, and change management.

II. Purpose and Justification

The purpose of this project is to optimize how PharmaAdvance selects, prioritizes, and manages its portfolio of project, specifically in R&D, regulatory, and product development. The justification lies in increasing Return on Investment (ROI), reducing time to market for new drugs, and ensuring compliance and transparency in project selection and execution. This supports strategic business goals such as innovation leadership, regulatory compliance, and sustainable growth

III. Scope Description

This project will result in the implementation of a comprehensive PPM framework, including:

· Deployment of a PPM software solution (e.g., Planisware or Clarity PPM)

· Creation of standardized project evaluation criteria

· Integration of risk, cost, and value analysis tools

· Development of dashboards for executive visibility

· Governance model to ensure project alignment with corporate strategy

· Training modules for project and portfolio managers

IV. High-Level Requirements

· Ability to score and rank projects based on business value

· Integration with existing ERP and R&D systems

· User roles and access control functionality

· Real-time analytics and reporting dashboards

· Customizable workflows for different departments.

· Compliance with FDA/E<A and data privacy regulations

V. Boundaries

Included

· Corporate-wide deployment of PPM across R&D, regulatory, and operations

· Software customization and integration

· Change management and training

Excluded

· Full ERP replacement or reengineering

· Legacy project clean-up unless needed for migration

· Changes to regulatory submission processes outside of portfolio selection

VI. Strategy

The project team will follow a phased Agile-Waterfall hybrid methodology. The initial planning and requirements phases will use a waterfall approach, followed by iterative deployments and testing of the PPM tool. Stakeholder engagement, training, and change management will run in parallel. A project governance committee will oversee progress

7. Acceptance Criteria

· All critical users have access to the PPM system with role-appropriate permissions

· Minimum 90% of active projects rated using the new value-based model

· Portfolio dashboards are available and populated with live data

· Users complete training and score ≥80% on post-training assessments

· All integrations tested and approved by IT and business units

· All critical users have access to the PPM system with role-appropriate permissions

· Minimum 90% of active projects rated using the new value-based model

· Portfolio dashboards are available and populated with live data

· Users complete training and score ≥80% on post-training assessments

· All integrations tested and approved by IT and business units

VIII. Constraints

· Limited availability of SME (subject matter expert) resources.

· Budget cap of $1.2 million for development and implementation.

· Completion deadline of 12 months from project start.

· System must support multi-sites, multi-phase clinical trials

IX. Assumptions

· Leadership will support change and resource allocation

· All business units will participate in the training

· Current project data is complete enough for migration

· Regulatory requirements will remain stable during implementation

· Chosen software will be compatible with existing infrastructure

X. Cost Estimate

Cost Category	Estimated Cost (USD)
Framework Design & Consulting	$250,000
Software Customization/Tools	$400,000
Training and Change Management	$150,000
Pilot Implementation	$200,000
Contingency (10%)	$120,000
Total Estimated Cost	$1,120,000

XI. Cost/Benefit Analysis

Costs:

· Total estimated cost: $1.12 million.

· Opportunity cost due to resource reallocation during pilot.

Benefits:

· Improved project success rate by 15–25%.

· Faster time-to-market could yield millions in early revenue.

· Better resource allocation resulting in cost savings across portfolios.

· Enhanced ability to prioritize high-impact, high-value projects.

· Long-term strategic alignment reducing project redundancy and failure.

Conclusion: The long-term financial and strategic benefits significantly outweigh the implementation cost, making this project a high-value investment for sustainable portfolio growth in a competitive pharmaceutical environment.

Phase II

Work Breakdown Structure (WBS): Value-Driven Project and Portfolio Management

WBS Code	Task Name	Description
1.0	Project Initiation	Prepare for project launch and define scope
1.1	Define Project Charter	Document goals, stakeholders, objectives
1.2	Identify Stakeholders	List internal and external project stakeholders
1.3	Conduct Kickoff Meeting	Launch project and align team expectations
2.0	Planning Phase	Develop detailed project plans and gather requirements
2.1	Gather Business Requirements	Interview departments and capture needs
2.2	Define Evaluation Criteria	Create value-based scoring model for project prioritization
2.3	Develop Governance Framework	Establish decision rights and approval flow
3.0	Tool Selection and Implementation	Select and configure the PPM software
3.1	Evaluate Vendors	Compare PPM tools (e.g., Planisware, Clarity, etc.)
3.2	Select Software Vendor	Finalize contract and licensing agreement
3.3	Configure and Customize Tool	Tailor workflows, roles, and integrations
4.0	Integration and Testing	Integrate PPM tool with existing systems and validate functionality
4.1	Integrate with ERP and R&D Systems	Link with Oracle/SAP and legacy databases
4.2	Conduct System Testing	Perform user acceptance testing (UAT) and resolve bugs
4.3	Validate Compliance Requirements	Ensure system meets regulatory and data privacy requirements
5.0	Training and Change Management	Prepare users and manage adoption
5.1	Develop Training Materials	Create guides, manuals, and training content
5.2	Conduct User Training Sessions	Train end-users, PMs, and executives
5.3	Implement Change Management Strategy	Communicate benefits, manage resistance, and reinforce adoption
6.0	Go-Live and Transition	Launch the solution and transition to operational support
6.1	System Go-Live	Launch PPM tool across departments
6.2	Post-Go-Live Support	Provide immediate support and troubleshooting for users
6.3	Final Project Review and Closure	Document lessons learned, archive files, and officially close the project

References

Heldman, K. (2021). PMP project management professional exam study guide (10th ed.). Wiley. Kerzner, H. (2022). Project management: A systems approach to planning, scheduling, and

controlling (13th ed.). Wiley.