Edward Everett Email & Phone Number

Eastpoint, FL, US

Fremont, California, US

Provide IT Project Management for Pharmaceutical Manufacturing.

For GMP Systems, performed data integrity assessments and created/updated Admin SOPs. Identified supplemental CSV for applications.

Managed Quality oversight for IT System implementations requiring GxP Validation. Organized, reviewed, and approved CSV artifacts. Provided guidance on regulatory requirements. Created Policies and SOPs to support a robust CSV process.Managed a Data Integrity project for a Biotech client. Performed an assessment of all systems and end-to-end data flows in.

Managed projects for Digital Asset/Content Management applications. Work performed in an Agile/Scrum framework following SDLC methodology.

As a consultant to GSK, Managed the schedule and activities for a pharmaceutical manufacturing and distribution site ownership transfer. Managed workstream timelines for IT, Quality, Engineering, Supply Chain, HR, and others. Needed to ensure GxP documentation was created, re-branded, or obsoleted. Worked with new ownership to dovetail restart activities.

As a consultant to AstraZeneca, I was responsible for delivering Big Data projects for Commercial Marketing into a Cloudera (Hadoop) instance hosted in the Amazon VPC cloud. The team I managed was a mix of on-shore and off-shore resources comprised of Business Analysts, Solution Architects, Developers, and Testers. Data was sourced from Veeva.

As a consultant to J&J, I managed a ~$7 Million implementation of Planisware following an Agile Scrum approach. The project followed the J&J SDLC and PMx standards. This Project and Portfolio Management (PPM) system will provide a single source of truth across Medical Devices for J&J. I worked with the vendor to map their release plan into the overall.

As a consultant to J&J, I managed a GxP validated implementation of Salesforce in the Global Consumer Care organization. This global application includes Service Cloud and Marketing Cloud as well as third party apps. I organized and coordinated activities between multiple workstreams including IT development, change management, application support, and.

As a consultant to Ethicon Endo Surgery (J&J), I provided program management consulting services to the Labeling Center of Excellence. The current program is an implementation of a new execution process for labeling of medical devices (21 CFR part 820). In addition to managing program governance, I handled issue escalations from the project managers for.

At Ethicon (J&J), I provided program and project management consulting services for Quality, Regulatory, and Compliance programs/projects for medical devices (21 CFR part 820). Provided project management guidance for a Quality Systems Integration effort. Facilitated the monthly status slide updates across 12 work streams and prepared for management.

Provided Project Management leadership for re-validation effort on numerous GxP systems in support of Medical Devices and Diagnostics. Harmonize existing applications with client's SDLC producing validation documentation set as an output following GAMP 5 approach. Ensure 21 CFR Part 11 and Part 820 requirements are met.Managed re-validation and testing of.

Atlanta, Georgia, US

Scrum Master for Clinical Data Analytics projects. Facilitate planned releases according to the Release Plan for the organization. Implement a workable scrum framework.Program Manager for Clinical IT projects at a pharmaceutical client. Managed projects to migrate Clinical solutions/data to a new AWS big data architecture for improved Analytics.Managed.

April 2011 - January 2014: Service Lead, Safety & Regulatory Book of BusinessLed, managed, and coached a global team of 22 onshore and offshore resources in operations and support of Book of Business activities for Global Safety, Compliance, and Office of Chief Medical Officer. Supported activities include adverse event reporting, compliance, audits and.

New York, New York, US

Defined and implemented IT strategy for Clinical, Safety, and Reporting (R&D IT) (21 CFR parts 11, 210, 211). Focus areas of Global Pharmacovigilance and Adverse Event / Safety Reporting. Successfully implemented offshore development model with onshore support. Additional responsibility of driving Clinical R&D projects to successful completion..

Forchheim, DE

Managed multiple software and IT projects for multi-million dollar, internet-based, healthcare information system.

Consultant in software development for intranet and internet applications with the largest clients being FirstUSA, GlaxoSmithKline, and Siemens Medical Solutions. Development was iterative and RAD primarily using Java (J2EE) and Oracle.

M.S., Computer Science

Software Security Foundations Certificate, Software Security

B.S., Math