Michael Wright

About Michael Wright

Project Management Skill Sets Team Leadership • Work with project team and key stakeholders to devise best practices and continuous improvement of project delivery across the enterprise. • Synchronize the efforts of major initiatives involving multiple groups and departments. • Trained, coach, mentor and motivate PMs and leads. • Escalate issues and concerns appropriately. • Consider, prioritize and balance the competing needs of diverse stakeholders daily. • Manage matrixes of resources and related relationships within each functional area. Project governance and communication • Maximize productivity by setting clear expectations and proactively communicating project status, issues and risks to external, internal stakeholders and senior management. • Draft and distribute project objectives and tasks to the cross functional team. • Negotiate successfully with clients, staff and outside vendors. • Continue to nurture relationships with project sponsors (internal or external). • Develop and disseminate a clear vision by linking projects to the company’s objectives (MBOs) and results. • Developed quarterly (or more frequent) meeting with senior management to review status of projects Project Provision • Direct and oversee multiple PMs and/or team leads on complex projects. • Ensure integrity and delivery of multiple projects with respect to time, budget, scope expansion (creeps), change, risk and resources. • Assess project issues and identify solutions to meet productivity, quality and customer goals adhering to GXP (GCP, GLP and GMP). • Manage resource allocation across multiple projects including tracking resource bandwidth and forecasting future availability for scheduling new projects. • Assure the attainment of key milestones by proactively tracking metrics and project outputs. • Apply effective project management methodologies and control techniques. • Mitigate risk by identifying, escalating and resolving issues across multiple delivery groups and/or projects

Experience

1. Lead Service Specialist Samd

   Johnson & Johnson

   Nov 2017 — Present · West Chester, PA

   Responsible for consulting with Business Partners to steer requirements, develop solution alternatives and estimates, as well as translating client business requirements into specific technical systems/applications or process designs for SaMD solutions. Will also coordinate activities of multiple cross functional teams within IT, our business partners and vendors. Additional responsibilities include supporting the SaMD Regional Service Owner (RSO) to drive continuous improvement of the SaMD service offering.

Education

• Philadelphia University

  Facilitator, SAS Programming Relational Theory

  2000 — 2003

• Widener University

  Management Information Systems, General

• University of Pennsylvania

  MS, Global BUS MGT (Diversity Program)

  1998 — 2004

• Rosemont College

  Bachelor of Science, Business Management

  1996 — 1998

Skills

• Account Management
• Gcp
• Regulatory Affairs
• Gmp
• Cross-Functional Team Leadership
• Oncology
• Outsourcing
• 21 Cfr Part 11
• Fda
• Pharmaceutics
• Management
• Budgets
• Clinical Development
• Clinical Trials
• Team Building
• Ich-Gcp
• Medical Devices
• Line Management
• Biotechnology
• Sales Operations
• Strategy
• Clinical Research
• Databases
• Sas
• Computer System Validation
• Contract Negotiations
• Oracle Clinical
• Ms Project
• Protocol
• Sop
• Project Management
• Crf Design
• Leadership
• Testing
• Regulatory Submissions
• Software Documentation
• Performance Metrics
• Infectious Diseases
• Edc
• Team Leadership