SUMMARY

• Confidential has extensive work experience troubleshooting, supporting, and training for numerous IT applications within highly FDA regulated environments.
• Confidential has excellent administration, customer service support, and Project Management/Coordinator experience.
• Confidential has superb communication skills, lives locally, and is available immediately.

CORE COMPETENCIES:

• Exceptional ability to format and organize fluid and dynamic business environments and organizations
• IT Project & Program Coordination in agile environments
• Expertise in tracking Risks, Actions, Issues, Dependencies, and Decisions to resolution
• Project, Program, and Portfolio Management
• Campaign Management Coordinator
• Technical Writing, EDMS Specialist
• SDLC Documentation Specialist
• Scheduler / Service Delivery
• Release, Point Release, and Patch Manager
• Inspection Readiness and Response
• ITIL Librarian / Release Coordinator
• Compliance & Quality Assurance
• Legal Reviews Coordinator
• PRC Coordinator

TECHNICAL SKILLS

Software: MS Office, MS Project, MS Project Server, Confidential ALM, SharePoint, TrackWise, Service Now, Remedy, JIRA, Documentum, Adobe, SAP WMS Modules, Tableau, UNIX, Confluence, Project Server, Data Repositories, Fire Host, LMS (Saba, Compliance Wire, Success Factors), Clarity, Crystal Reports, Cognos Reports, Confidential Task, Primavera, PeopleSoft, Solution Manager, Rational Rose, InfoPath Forms, FrameMaker, HTML, SQL, Sum Total, and some familiarity with Tin Hat, Compleo, and Daptiv

Applications: Appature’s Nexxus Marketing Campaign Manager Platform, Werum’s MES PAS - X

PROFESSIONAL EXPERIENCE

Jr. Project Manager Consultant/PMO Analyst

Confidential, Princeton, NJ

Responsibilities:

• Coordinated off-shore and near-shore release management of projects in the Confidential commercial IT project portfolio
• Tracked milestones to plan on a dynamic, fluid, very market-centric marketing program
• Tracked risks, issues, actions, and decisions determinedly to resolution across the project
• Co-led new incident, change management, and release management initiatives currently being implemented on Maestro Service Now Coordinator
• Used Tableau Server version 8 on the IMS Health Appature Nexus Platform (campaign event management tool) Insight Server, opened and analyzed static files, and ran reports; helped communications between vendors regarding data quality
• Change control facilitation between disparate organizations
• Maestro artifact Librarian (routed documents through GQ-EDMS)
• Routed legal agreements and SOWs through service management suite, ensuring approvals and rejections are sufficiently documented
• Acted as Data Project Coordinator for the Maestro project, a marketing campaign engagement and analytics project.
• Worked with the numerous different vendors (Nexus Platform tool by IMS Health, call centers, ad agencies, samples programs, speaker programs, etc.)
• Helped coordinate data alignment, operational reports, analytics views, inconsistencies from Tableau, etc.
• Acted as Coordinator and Liaison to the Sales Ops, Digital Marketing, and ATLAS DB teams
• Coordinated and proofed FIA (File Interface Agreements)
• Facilitated KPIs and web analytics meetings between the different Maestro project vendors and agencies
• Reviewed deliverables to ensure all vendor documents were using the correct template and complied with the template requirements before the documents were sent to Confidential &V

Quality Assurance Specialist/Technical Writer/LMS Admin Contractor

Confidential, Bridgewater, NJ

Responsibilities:

• Primary responsibilities included the maintenance and administration of the U.S. Pharmaceutical Operations Standard Operating Procedure (SOP) System, a Documentum-based system
• Maintained the U.S. Confidential training metrics, KPIs, and records
• Acted as SABA (an LMS) Administrator for U.S. Confidential

IT and Compliance Coordinator Consultant

Confidential, Lebanon, NJ

Responsibilities:

• Project Coordinator of MMD IT ( Confidential Manufacturing Division IT) incidents management, change management, and problem management including known errors, and knowledge management using Remedy as well as paper-based protocols and forms (skill level in Remedy: Specialist)
• Ran reports from Cognos and Remedy for incidents tracking, trends analysis, and inspection readiness; assisted in creating configuration items and assets into Remedy
• Project Coordinator using Quality Center/ALM for tracking COMET (Collaborating on One Confidential Enabling Transformation, an ambitious enterprise-wide transition to SAP for all workstreams such as OTC, SCM, FBM, STS, and HR) unit, integration, operational test cases tracking, and TIRs resolution and follow-ups; mapped TIRs to Remedy incidents/change controls. (skill level in QC: Associate Specialist to Specialist)
• Entered MES site application and server configuration items data into the Confidential Enterprise Remedy CMDB; maintained MES Site CI data in the CMDB
• Release Management Coordinator for complex deployment releases of MES product based upon Werum’s PAS-X product
• Assisted in the maintenance and administration of build/release systems; incorporated new development projects into existing build structures
• Assisted with software configuration management tasks like branching, merging, and tagging the source code in Subversion
• Coordinated internal audit as a pre-PAI exercise for MMD IT periodic reviews to ensure compliance to timelines standards and completeness of each of the periodic review reports
• Lead MES (Manufacturing Execution System) Project Documentation Specialist/Technical Writer; helped author and edit all SDLC Deliverables. Created and maintained two SW and documentation configuration item lists for two versions of the MSD core MES product based upon the base product Werum’s PAS-X versions 2 and
• Maintained MS Project plans for the MES global project as well as MES site-specific project plans
• Lead in moving from paper-based, wet-signature approvals to MIDAS (an electronic document management system) electronic approval workflows
• Spearheaded the use of the MMD divisional iterative development approach SOP; helped create new SOP templates, forms, and tracked usage of the SOP into MMD
• Authored and deployed 30 MES communiqués to the MES global sites; assisted in the creation of several MES-impacted MMD IT technical bulletins
• Tracked and monitored MMD IT projects using JIRA
• Coordinated resource management for the MES CoE using PlanView
• Lead MMD IT MIDAS Steward ( Confidential ’s Electronic Documentation Management System) - on-boarded, trained, troubleshot MIDAS issues such as stuck Approval Workflows and PDF Watermarking issues. Maintained numerous MIDAS Workgroup membership listings and ensured every member met the required MIDAS Training requirements needed for his/her respective role. (Skill level In MIDAS: Sr. Specialist). One of the top contributors to the Confidential Content Management Community Site.
• Following Divisional SOPs, conducted annual audits of access and role profile permissions of MMD IT Workgroup users of the MIDAS (a Confidential Electronic Document Management System).
• Lead MMD IT myLearning Admin using LMS - coordinated migration of over 250 MMD IT courses from the older generation MELS system to LMS. Created courses and new revisions and curriculums for MMD IT Projects. There are approx. 80 GMP-impacted systems within MMD IT. (Skill level in LMS - Specialist)
• Project Coordinator for Tracking CAPAs and NOEs using TrackWise.
• Project Coordinator (document compliance, inspection-readiness, records entry, Learning Management System support, MIDAS Support, Remedy Support. TrackWise entry and reporting) for the GQTS Suite of Systems Confidential Confidential including:
• GQTS CAPA Tracking of corrective and preventative action commitments primarily resulting from audit and deviation observations
• GQTS Deviation Management System - tracking various types of deviation occurrences captured Confidential a site.
• GQTS TrackWise® Global Platform TrackWise Global Quality Tracking System-Used by Global Quality. Contains Global Change Management, Customer Complaint, Deviation Management, Internal Audits tracking modules. Tracking Validated Documents in the Tracking System.
• Ran Crystal Reports from TrackWise in prep of weekly status meetings.
• Assisted in the AIQ (Automation Installation Qualification) of the MES CoE Lab for Clients and Devices. Coordinated Unit, IQ, OQ, and PQ Testing for four TRANSIT Workstreams: LIMS, Warehouse Management, Inventory Management, and Weigh and Dispense against rigorous and aggressive COMET Go Live releases.
• MES CoE and MES Sites SharePoint Designer, System Admin, and Coordinator. The MES TeamSpace is among one of the largest and most extensive and intricate Confidential Confidential . (Skill level in SharePoint - Specialist)
• Project Coordinator for MMD IT Compliance, Risk Management, and Quality Assurance including such activities and initiatives as updating and retiring MMD IT General SOP and Above-Sites SOPs, SDLC Training via myLearning, maintained a huge MMD IT Inspection Readiness Contacts and System Details. Created assets in Field IT Inspection/Audits tool.
• Alarm Point Coordinator the MES System. Maintained 24x7 Support Calendar for the MES CoE to ensure CoE support for Global MES Incidents and Outages.
• Well versed in vendor Quality Systems - gave feedback to vendors on how to improve the Quality Assurance aspects (such as FATs and SATs).
• Coordinator of massive MMD IT Inspection Readiness Efforts for MMD IT PAIs. Assisted projects in ensuring all of their respective SDLC documentation was current and readily accessible for FDA Audits and Inspections. Ensured for each project that only follow-up items detailed in the latest approved version of the system QASR (Qualification Assurance Summary Report) were closed out within the time frame called out in the QASR.
• Helped prepare the MMD IT PAI Findings Response to ensure the responses were aligned and coordinated for the Confidential Gateway. The emphasis was on showing the FDA ancestral requirements tracing throughout the SDLC entire lifecycle. Updated MES Global SOPs to include recommendations specified by the FDA.
• Coordinated System Requirements for input into the SolMan (SAP Solution Manager). Ensured files were properly checked in, checked out, and locked.
• Delivered timely meeting minutes, meeting facilitation, and served as TRANSIT (Shop Floor Systems Remediation for COMET) SDLC Documentation Librarian for the Weigh and Dispense, LIMs, Inventory Management, and Warehouse Management Workstreams. Coordinated the Data Migration efforts of Legacy Shop Floor Systems to COMET.
• Coordinated Vendor Management and SLA Preparation and Coordination with MMD IT Vendors such as Werum, Sparta, HK Systems, and HP. Tracked Vendor SCRs to ensure proper inclusion in Vendor Product Version Release Notes.
• Help Desk Coordinator: Created Help Desk Analysis and Troubleshooting Scripts that the Americas Help Desk Confidential Confidential used quite effectively resulting in far greater accuracy of the Incidents and Trouble Tickets being routed to the correct Support Group first time. Also authored on-line Service Request forms used by the Confidential Portal.
• Coordinator of Decommissioning MMD IT Systems - ensured adherence and compliance to a rigorous and multi-faceted Decommissioning Checklist.
• Coordinated Supplier and Third-Party Audit Results entry into the eSTARS System.
• Project Coordinator for Code Versioning using the Subversion Systems. (Skill level in Subversion - Associate Specialist)
• Coordinator for Test Cases using ClearQuest. (Skill level in ClearQuest - Associate Specialist)
• Lead Trainer for exceptionally well-received Data Integrity Course. Presented this instructor-led course to internal Confidential employees, contractors, and third-party suppliers - anyone who touches Confidential Data.
• Coordinated MMD IT Risk Assessments. Helped devise the spreadsheet gird template. Ensured all high and medium Risks were paired with sufficient Mitigation Strategies and ensured low risks were well documented to demonstrate why there were determined by the Risk Assessors to be low risk.
• Co-Admin and member of the site Governance Board of the MMD IT Compliance Community Site (SharePoint driven) and co-admin of the SDLC TeamSpace.
• Completed Prelim Training of SumTotal Learning Management Software.

Business Analyst / Project Coordinator

Confidential, Piscataway, NJ

Responsibilities:

• Worked with Confidential and Confidential Process Consultants to design and implement a new Governance Process for new J&J Health Care Systems (JJHCS) projects. The new Governance Process streamlined, harmonized, and strengthened the process of J&J HCS MD D Franchises (such as Cordis, Ethicon, Endo Ethicon, ASP, Therakos, Biosense Webster, OCD, DePuy, Lifescan, and Codman) submitting and realizing their multiple respective project enhancement requests.
• Coordinated new documentation project-tracking templates, weighting tools, and scorecards. Tracked, documented, and presented the project acceptance, testing, implementation, and post-implementation phases of over 200 projects to JJHCS Leadership teams.
• Maintained and updated the entire Governance Process Projects Portfolio. Working with Strategic Business Managers, IM, and Financial Analysts, edited and proofread hundreds of BOAs (Business Opportunities Assessments) and BSAs (Business Solutions Assessments).
• Took the JJHCS Meeting Minutes Confidential the Governance Scoping Sessions and the Solutions Design Meetings. Followed up speedily on all action items and follow-ups to timely completion.
• Wrote the new SOP accurately documenting the new Governance Process with pinpoint precision. Also, updated edited numerous Supply Chain and Quality Assurance SOP's, making all target dates. SOPs passed SOX compliance and were implemented.
• Recorded and documented detail findings from Security and SOX Supply Chain audits. Wrote correction action plans with accompanying timelines for audit results. Managed all follow-ups to a successful and complete resolution.
• Recorded and documented detail findings from Security and SOX Supply Chain audits. Wrote correction action plans with accompanying timelines for audit results. Managed all follow-ups to a successful and complete resolution.
• Coordinated the production and implementation of patient recruitment and retention campaign materials to support both J&J internal and external global clinical trials for a myriad of therapeutic areas and lifestyle-management enhancement programs. Monitored program materials movement and inventory levels.
• Worked with Division Financial Representative to prepare monthly forecast income statement.
• Oversaw all aspects of supplier vendor deliverables to ensure implementation within stiff timelines and budgets and to ensure internal standard policies and processes were followed.
• Tracked inventory and movement of global clinical trials recruitment and retention patient and professional materials from development to the translators to design to printing to fulfillment Confidential the Clinical Trial Sites.
• Monitored the progress of recruitment and retention materials and services Purchase Orders from order placement to delivery.
• Pursued corrective and proactive action to detect and to avoid late materials of bulk orders.
• Created and maintained thorough documentation and spreadsheet files to accurately present a clear audit trail with regard to procurement and shipping.
• Provided research and analysis for new and renewed business contracts. Assured suppliers met all compliance requirements.

Tech Writer Consultant

Confidential

Responsibilities:

• Documented with precision and accuracy the new, richly-featured Undergraduate Admissions web-based, PeopleSoft-based platform system. Working with the Business Processes Teams, created a new User Guide, Installation Guide, and Reference Cards for the Princeton Undergraduate Admission Office.
• Coordinated Status Meetings between the Technical Writing Contractor Staff with the Princeton U Business Process Owners to ensure documentation projects were on target.

Data Migration

Confidential, Bridgewater, NJ

Responsibilities:

• Working as a specialist as part of a mass data migration project, migrated archived decades of Time magazine content from microfiche to static (not hyperlinked, web-based) Confidential graphical, human-readable files using Confidential advanced scanning technology.

Senior Technical Staff Member

Confidential, Middletown, NJ

Responsibilities:

• Release, Point Release, and Patch Management for the PQRS, WMS, and RUBY Projects.
• TMO Coordinator
• Business Analyst and Project Coordination for numerous large-scale to mid-scale Network Operations Systems. Provided project initiation, planning, execution, and reporting. Tracked individual developers milestones as well as project-wide milestones to ensure the release and the entire cogent work program were on schedule and on track.
• Created, conflated, and presented project proposals, project plans, status reports and metrics scorecards to upper leadership in a confident and concise manner.
• Acted as an effective liaison between the different Project Managers to realize improved project stability, efficiency, effectiveness, and communications.
• Singularly drove the project communications. Ensured project plan was consistently adhered to yet provided some flexibility into project plans to allow for roadblocks, funding changes, or supplier-delivery issues. Monitored compliance with existing standards.
• Managed the project schedule and ensured it complied with the stated project goals and targets.
• Coordinated milestone activities and efforts of sub-teams and task forces to ensure the demands of the project were being met.
• Maintained project communications repository.