Winifred Egan
Hackettstown
Summary
Results-oriented professional specializing in portfolio and program management with expertise in organizational change, compliance, clinical trials, and marketing. Proven skills in strategic planning and leading cross-functional teams to deliver complex projects. Experienced in enhancing client engagement through innovative relationship strategies and adept at navigating internal and external challenges.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Targeted Skills Certifications
Professional Development Sabbatical
Remote
11.2025 - Current
- PMI Project Management Professional Certification (PMP)
- Prosci Certified Change Management Professional (CCMP)
- Prosci Certified Advanced Change Practitioner (PCACP) Courseware prep
Director: Program/Change Management Global
Medasource Life Sciences
Remote
08.2025 - 10.2025
- Finalized organizational change management initiatives for global transition.
- Directed strategic initiatives to enhance operational efficiency across multiple departments.
- Collaborated on strategic communication plans, KPIs, and change management trackers.
- Conducted alignment analysis with cross-functional teams, enabling continuous progress.
- Managed budgets and allocated resources effectively for various projects.
- Established partnerships with stakeholders and vendors, securing favorable terms for project resources.
- Created Smartsheet status updates and generated comprehensive reports.
- Provided assessment feedback on AI-generated solution reporting tools.
- Completed short-term contract assignments for various clients.
Sr. Director, Program/Project Management
CMK Life Sciences
Parsippany
02.2022 - 03.2024
- Purdue Pharmaceutical Drug Commercialization Initiative
- Led portfolio and program management efforts supporting initiatives across full drug development lifecycle — from pre-clinical through clinical trials (Phases I–III), regulatory, and compliance.
- Directed all aspects of Commercial Drug to Launch program including planning, budgeting, staffing, scheduling, monitoring, and reporting.
- Clinical & PMO Portfolio/Program/Project oversight of Marketing Commercialization/Drug to Market portfolio for Fortune 500 Pharmaceutical firm.
- Managed workstreams and deliverables for marketing training, contract reporting, IT, legal, regulatory compliance, supply chain, distribution, sales force development, pharmacy distribution, and medical affairs.
- Managed strategies and relationships with external vendors and internal stakeholders, including sourcing, procurement, finance, and clinical operations teams.
- Initiated formalized Change Management framework to identify and manage process changes within workstreams.
- Defined/Operationalized framework for entire portfolio program.
- Oversee business partners to drive creative content deliverables via multi-channel brand approach with Ad agencies, Production agencies, and Sales & Training (KAM/NAE) via SalesForce.
Associate Director/Director Program Management
JGB BioPharma
So. San Francisco
06.2021 - 09.2021
- Developed and oversaw program development plan for NDA filing and clinical program launch.
- Managed overall program for global clinical program, reporting to director and VP.
- Finalized short-term FDA submission oversight program.
- Oversaw operational and strategic aspects of corporate partnerships in regulatory and medical affairs.
- Manage remaining Sr. leadership communications & presentations, status meetings for Clin Ops, Scientific teams including Oncology, HEOR, and CMC (Metabolism) sub-teams.
- Support Clin Ops team timeline review for PKV, CRO biomarker activities and Clinical study activation, conduct and closeout.
Sr. Portfolio Program Management
MMI Life Sciences
Basking Ridge
03.2019 - 04.2021
- Sr. Portfolio & Program Management for Global Clinical Development. Responsible for management of assigned pharmaceutical organizational portfolio/program/project initiatives within global development as part of the transformational framework.
- Led portfolio management for IT/RPA and BPM Robotics Division, overseeing project initiatives and resource allocation.
- Managed strategies and relationships with business partners, including vendors, communications, change management/training, sourcing/procurement, and finance.
- Provided assessment, direction, and reporting in portfolio/program management and change management design, including stakeholder communications, operational standards, KPIs, roadshow presentations, and HR rewards and recognition programs.
- Oversaw portfolio, program, and project-level business processes, including status reporting against spending, RFP and SOW approvals, and budget oversight.
- Provided all senior-level status reporting, including portfolio updates, stakeholder information, steering committee briefs, and leadership team summaries.
- The portfolio encompasses IT, Clinical/Pre-clinical (including Oncology), Drug Development, R&D, Regulatory, Compliance, Safety, Training, Change Management, HR.
- (Regeneron Pharmaceutical PMO Portfolio Director)
Organizational Program Change Management Principal
Chaucer Life Sciences
Bridgewater
06.2017 - 06.2018
- Team Director for overall Phase 1 design and implementation of a pharmaceutical organizational global change program with a focus on transformational change in the Regulatory & Compliance arena.
- Governed global program portfolio, overseeing ongoing and new technology projects to ensure alignment with strategic objectives.
- Assessed and directed organizational re-design and change management execution, enhancing communication strategies to support transformational initiatives.
- Defined and implemented communications strategy and plan, facilitated stakeholder identification and approval, and organized roadshow presentations and educational materials, including training and i-learn finalization.
- The program portfolio encompasses strategic identification and organizational carve outs in multiple countries including the US.
- Additional responsibilities include FDA IND/NDA process oversight, executive leadership reporting, steering committee presentations, events Congress, and overall program support.
- (Sanofi Pharmaceutical Portfolio Initiative)
Sr. Portfolio Manager
Aequor
Swiftwater
12.2015 - 04.2016
- Led all marketing and communications strategies for small and large complex organizational projects and programs.
- Led organizational program initiatives, enhancing client communication and improving CRM management.
- Manage cross-functional project teams including focus groups, statistical compilations, and project reporting.
- Manage cross-functional project teams including internal and external services.
- Create and manage required project plans from inception to implementation.
- Manage project resource needs as well as contingency plans.
- Conducted QA and risk management assessments to identify potential issues and ensure timely project deliverables.
- Perform Quality/Compliance reviews and quality analysis assessment of existing Management and Communications processes, tools, and standards to improve quality and enhance efficiency.
- Reviewed and approved technical documentation to ensure compliance and accuracy.
- Technical documentation review/approval against CFR Part 11/Regulatory & Compliance as well as RFIs, RFPs, SOP (s) oversight and adherence.
- Assess existing program, contracts, RFQs, RFPs, process mapping and change management methodologies, operational tools and current service offerings that can be leveraged across all groups for close out.
- Assess vendors, contracts, RFQs, RFPs, process change management methodologies, communications and operational tools and current service offerings that can be leveraged across divisions.
- Managed all internal and external client communication requests, including proofreading and rewriting documents.
- Coordinated client events including focus groups, training forums, and meet & greets to foster engagement and gather feedback.
- Provided training through course curriculum development, e-training, and formal classroom instruction on all tools and standards.
- Provide Project assessment, and status at Team Review meetings.
- Provide Project Management Training and tutorials.
- Finalized short-term clinical programs as part of project responsibilities.
Professional Organizational Management Consultant
Multiple Pharma Client Initiatives
Remote
10.2014 - 04.2016
- A professional consultant who managed overall program and project initiatives.
- Reviewed and managed communications and strategies for complex projects and programs.
- Facilitated stakeholder workshops to clarify project goals and expectations.
- Developed communication and operational tools for use across all groups.
- Managed client communications to ensure clarity and alignment.
- Short-term Program Consultant
Senior Business Program/Project Management CRM, Vendor Relationship Management
NAT Communications
Bergen
10.2014 - 12.2015
- Report to V.P. of PMO (Short-Term Finalization Contract).
- Re-engineered CRM framework and finalized processes for work plans, communications strategies, and financial plans.
- Senior leadership relationship throughout multiple departments to define/finalize existing processes via re-engineering & CM framework, finalize work plans, communications strategies and plans for managing complex projects and programs.
- Managed vendor assessment and contract review, building comprehensive PM communications tools and service offerings for cross-group leverage.
- Developed proposals and finalized processes with in-house clients and external vendors, including contract reviews.
- Facilitated meetings and managed periodic program updates with key stakeholders to ensure alignment.
- Project status communications and communications strategies to project sponsors and key leadership.
- Facilitate key meetings with senior leaders and stakeholders.
- Project and Communications Plan authoring, oversight, execution, and budget/headcount management.
- Execute communication strategies, tools, templates, and methodologies for project management and leadership alignment.
- Provide project leader oversight assistance in authoring and executing mitigation plans for all project risks and issues.
- Manage financial and operational risks and issues.
- Provided oversight and guidance on PMO education, including SOPs, best practices, QA, compliance, and regulatory standards.
- PMO education oversight and guidance; SOPs, Best Practices, QA, Compliance and Regulatory.
- Document new and existing policies and procedures as Lessons Learned to be used as ongoing best practice documents.
- Evaluated social media and marketing opportunities to identify potential growth areas.
- Provide overview for dovetailing alignment in all projects and initiatives.
Senior Pharmaceutical Program/Portfolio Management (CRM)
Indegene Lifestyle Systems
Iselin
02.2013 - 11.2013
- Workstreams: Pharmaceutical: Clinical, Oncology, Medical Affairs, Consumer Products, General Medicines.
- Managed IT systems validation for manufacturing and pharmaceutical medical affairs, including vaccines.
- Client Organizational Business Programs/Portfolios: Communications, IT/Business Side, Web-Based/Content/Documentation Projects, Training, Voice Video, Special Projects.
- Oversaw client/stakeholder relationships, facilitated internal and external partnerships, managed vendor/client/physician relations, negotiated contracts, ensured effective communication channels, led program training initiatives, and directed medical authoring/editing oversight and review.
- Validated client initiatives and projects to ensure compliance with current regulatory standards and regulations.
- Created training materials to enhance staff proficiency in CRM software use.
- Facilitated corporate reorganization and relocation efforts to optimize operational efficiency.
Pharmaceutical Life Sciences
Freelance Program/Project Management
Remote
05.2011 - 05.2012
- Managed organizational structure and functions across HR, communications, medical affairs, IT, and special projects.
- Led project teams and activities for complex large-scale, cross-organizational projects.
- Oversaw project and program deliverables in communications, information management, and operations, ensuring alignment with organizational goals.
- Manage all communications for project tracking across business units.
- Prepared and presented project status updates, escalated issues with solutions, and outlined deliverable timelines to stakeholders.
- Facilitate meetings with clients (including multiple business and technology stakeholders) and team members.
- Developed and managed partnerships with third-party and internal service and data vendors, enhancing collaboration and resource utilization.
- Author & review regular stakeholder communication reports, program status reporting and program vendor assessment reporting.
- Provide content reviews of program and project related documentation.
- Directed project team members in QA approach and strategy for validated and non-validated systems.
- Review all QA Process, Quality and Regulated environment documentation.
- Provided oversight of technical writers/BAs through SDLC (System Development Lifecycle) process: Validation Quality Plans, Testing and closure.
- (Contractor/Subcontractor for various clients)
Program & Project Business Manager (CRM)
Novartis Pharmaceuticals Corporation
East Hanover
07.2006 - 05.2010
- Provided managerial and strategic direction to organizations within the client community and managed domestic and global programs, projects, and teams related to all business side clients and NDA/IND submission processes.
- Managed programs and projects using project management standards, including project development, budget reporting, and formal documentation such as project plans and status reports.
- Developed and implemented strategic business plans that supported corporate goals.
- Managed cross-functional teams to execute project initiatives and enhance collaboration.
- Collaborated with other departments within the organization to coordinate project efforts.
- Validate all projects (Compliance and Regulatory adherence) within the organizational framework.
- Author and manage all proposal submittals and vendor selection process for internal clients.
- Reviewed contracts with vendors and suppliers for compliance with company standards.
- Client projects include but are not limited to: USCO Tax Stream financial application project, Project Harmony (global payroll harmonization project), SharePoint Migration and the Message Broadcaster Communications Organizational Program initiative.
- Develop and manage relationships and deliverables with business owners, project sponsors (including business/technology stakeholders).
Education
Bachelor of Science - Management Labor Relations
Seton Hall University
South Orange, NJ05-1994
Skills
- Clinical Program Management
- Drug Development Cycle (R&D)
- FDA (IND/NDA) review & approve
- Regulatory & Compliance
- Compliance Management
- Pharmaceutical expertise
- Marketing Commercial Launch/Drug Development (Phases 1-4)
- Budget management
- Portfolio Management
- Project Management
- Program Management
- Risk assessment
- Stakeholder engagement
- Internal Stakeholder Relations
- Client Relationship Management
- Event & Congress Management
- Digital Transformation
- Data Analytics
- Vendor Management
- IT/Systems Validation
- Google Docs/Sheets
- Smartsheets: Program/Project Management
- Organizational & Change Management
- Executive Leadership Council (EC)
- Steering Committee/Stakeholder
- Training & Delivery
- Speaker Engagements/Leadership Council
- Time management
- Soft Skills
- Smartsheets: Program/Project Mgmt
Certification
• CCMP Certified Change Management Professional, Prosci, In Progress, 2027
• PMP Certification, PMI, 2026
• Agile Project Management at Work: Reporting with Agile Charts & Boards Course Credential, 2025
• Transitioning from Waterfall to Agile Course Credential, 2025
• Ethics in the Age of Generative AI, 2025
• Generative AI Tools Course Credential, 2025
• Change Management for Projects Course Credential, 2022
• Managing Organizational Change for Managers Course Credential, 2022
• Vital Change to Level up in Business Course Credential, 2022
• 5 Conversations of Accountability & Performance Course Credential, 2022
• Building Effective To Do List for Projects, 2022
• Managing Virtual Teams Course Credential, 2021
• Communicating about Culturally Sensitive Issues Course Credential, 2020
• Confronting Racism & Bias Course Credential, 2020
• CFR Part 11/Validation, 2025
• MicroStrategy Database Developers Course Certificate, 2000
• PMP Certification, PMI, 2026
• Agile Project Management at Work: Reporting with Agile Charts & Boards Course Credential, 2025
• Transitioning from Waterfall to Agile Course Credential, 2025
• Ethics in the Age of Generative AI, 2025
• Generative AI Tools Course Credential, 2025
• Change Management for Projects Course Credential, 2022
• Managing Organizational Change for Managers Course Credential, 2022
• Vital Change to Level up in Business Course Credential, 2022
• 5 Conversations of Accountability & Performance Course Credential, 2022
• Building Effective To Do List for Projects, 2022
• Managing Virtual Teams Course Credential, 2021
• Communicating about Culturally Sensitive Issues Course Credential, 2020
• Confronting Racism & Bias Course Credential, 2020
• CFR Part 11/Validation, 2025
• MicroStrategy Database Developers Course Certificate, 2000
Timeline
Targeted Skills Certifications
Professional Development Sabbatical
11.2025 - Current
Director: Program/Change Management Global
Medasource Life Sciences
08.2025 - 10.2025
Sr. Director, Program/Project Management
CMK Life Sciences
02.2022 - 03.2024
Associate Director/Director Program Management
JGB BioPharma
06.2021 - 09.2021
Sr. Portfolio Program Management
MMI Life Sciences
03.2019 - 04.2021
Organizational Program Change Management Principal
Chaucer Life Sciences
06.2017 - 06.2018
Sr. Portfolio Manager
Aequor
12.2015 - 04.2016
Professional Organizational Management Consultant
Multiple Pharma Client Initiatives
10.2014 - 04.2016
Senior Business Program/Project Management CRM, Vendor Relationship Management
NAT Communications
10.2014 - 12.2015
Senior Pharmaceutical Program/Portfolio Management (CRM)
Indegene Lifestyle Systems
02.2013 - 11.2013
Pharmaceutical Life Sciences
Freelance Program/Project Management
05.2011 - 05.2012
Program & Project Business Manager (CRM)
Novartis Pharmaceuticals Corporation
07.2006 - 05.2010
Bachelor of Science - Management Labor Relations
Seton Hall University