SUMMARY:

• 20+ years documentation management, technical writing, project management, business analysis, proposal management, sales analysis, and software training experience
• SCRUM Master certified
• Requirements & Software/Quality Testing
• (GXP) Quality/Validated Documentation Strong knowledge and proven experience in translation of business processes into Quality Document with the ability to read, understand and interpret process maps.
• Ability to prioritize assignments in accordance with assigned project deadlines
• Pharmaceutical industry experience writing quality documents to meet regulatory requirements across regions
• Ability to lead meetings to evaluate and confirm project team deliverables to create, review and revise Quality Documents;
• Utilization of ALM Software Development Lifecycle (SDLC) is used on every project for Software development
• Ability to Perform peer Quality Control on the Quality Document to ensure consistency/harmonization of processes by following quality document templates, writing rules and quality control checklist by respecting the quality document plan and timelines to ensure timely production of Quality Document deliverables

COMPUTER SOFTWARE PROFICIENCY:

MS - Word Excel Adobe PowerPoint Documentum QuickBooks Outlook PhotoShop Quicken PageMaker Corel Draw HTML BaaN IV Cognos SnagIT Ascendant Team Visio Publisher SalesForce.com SharePoint Access DocuProof WIKI

PROFESSIONAL EXPERIENCE:

Confidential, Hopewell, NJ

BUSINESS ANALYST /Technical Writer

Responsibilities:

• supporting the Mainframe ReEngineering project, I am fully responsible for the preparation, analysis and creation of various technology - based and architectural documentation utilizing a project SharePoint site.
• I conduct a wide variety of Business/Technical/Financial analyses by partnering across a variety of teams along with different levels of management.
• I am involved with teams to research and resolve project related issues while digesting the detailed information to identify risks, gaps, and provide conclusions to management.

Confidential, Princeton, NJ

Sr BUSINESS ANALYST/Project Manager

Responsibilities:

• I drove an enterprise Collaborative SharePoint project (WeCollab) to successful delivery and execution in an accelerated timeframe.
• With direction from the Associate Director Business Information Management (BCM) for the project, I worked closely with stakeholders from varying departments and locations in Clinical R&D and the CRO ( Confidential ), to fully capture and document the business and functional requirements, project plan, use cases, process flows, test scripts, communications campaign and additional analysis artifacts required as part of the project implementation.
• I have contributed to the technical and business architecture and roadmap for the capability, worked with IT architects, vendors, offshore resources and peers to ensure alignment with related initiatives.

Confidential, Plymouth Meeting, PA

IS BUSINESS ANALYST

Responsibilities:

• As an IS Business Analyst, I worked closely with stakeholders from varying departments to fully document the business and functional requirements, use cases, Quick Reference Cards, process flows, and additional analysis artifacts required as part of the departmental implementations.

Confidential, Lawrenceville, NJ

IS BUSINESS ANALYST

Responsibilities:

• As an IS Business Analyst, I drove an enterprise software project (Biomarker Data Repository, Integration, & Visualization Engine (BioDRIVE) Project and (VFR) to successful delivery.
• With direction from the Business Capability Manager (BCM) and PM for the project, I worked closely with stakeholders from varying departments and locations in R&D, to fully document the business and functional requirements, use cases, data dictionary, process flows, and additional analysis artifacts required as part of the project implementation. l contributed to the technical and business architecture and roadmap for the capability, working with IT architects, vendors, and peers to ensure alignment with related initiatives.

Confidential, Moosic, PA

IS SR BUSINESS ANALYST / SR .TECHNICAL WRITER

Responsibilities:

• As a Business Analyst, I was responsible for a variety of IS project activities in order to implement approved system / application requests from various business groups within.
• I partnered with functional and technical teams to gather and complete requirements, coordinated development activities, establish test plans, oversee and participate in testing activities, provide necessary documentation and ensure that quality solutions are implemented in a timely fashion for several projects required for launching a new product.
• PR5i SAP project

Confidential, Berwyn, PA

IS BUSINESS SYSTEMS ANALYST / SR .TECHNICAL WRITER

Responsibilities:

• I am responsible for all aspects of the analysis and requirements of assigned projects and provide a single point of contact for those projects.
• Interface with all areas affected by the project, both internal and external.
• Develop detailed requirements documents - both business and system, with traceability into development and test.
• Conduct requirements gathering, test prep and UAT meetings.
• Provide technical and analytical guidance to project team.
• Recommend and take action to direct the analysis and solutions of problems.

Confidential, Philadelphia, PA

IS BUSINESS ANALYST / SR .TECHNICAL WRITER

Responsibilities:

• Supporting projects and working with the project team and clinical physicians and doctors in the Cancer Research Department to capture and document business processes and needs for user, functional and technical requirements.
• Conceptualize, document and communicate the business, functional and technical constraints.
• Translation of technical designs for configuration and development and assess the implementation to meet the business needs/requirements.
• Support the unit and integration testing with documentation of the test plans, test cases, test execution, traceability matrices.

Confidential, Bridgewater, NJ

IS R&D TECHNICAL WRITER / BUSINESS ANALYST

Responsibilities:

• Support projects as a business/ technical analyst to work with the project team and business SMEs to capture and document business processes and needs/ gaps, functional and technical requirements utilizing Confidential ’s documentation management system (Documentum)
• Conceptualize, document and communicate the business, functional and technical constraints
• Work closely with the technical teams to assist in the translation into technical designs for configuration/ development and assess the implantation meets business needs/ requirements
• Work closely with the technical team to ensure that the unit and integration tests results meet with the documented requirements
• Assist the test lead and team to write test plans, test cases, execute test, support traceability matrix development and test documentation.
• Utilized SharePoint 2010 for the DITA exchange application and implemented the migration to SP2013.
• Utilize the AGILE methodology for the project management and PUMA Methodology for validated document management.

Confidential, Swiftwater, PA

IS R&D BUSINESS ANALYST / SR .TECHNICAL WRITER

Responsibilities:

• Utilize project management and analysis skills by coordinating business analysis and project deliverables via the PUMA Methodology, on a per-project basis for local North American initiatives, within the R&D IS area, in support of projects within the Global Clinical Immunology and BioStats departments.
• Act as a business liaison, systems integrator and implementer working closely with and under direction of the R&D IS Project Leaders to implement and support solutions for these business areas.
• Work closely with the business users to translate their needs and expectations and with R&D IS project leadership and portfolio managers along with IS shared resources to support their processes.
• Closely involved with business analysis; business data, process and workflow modeling; business case development; project planning and implementation; requirements gathering and analysis; software selection; system documentation, testing, and validation (where applicable); project resource management; change management; and post-implementation support related to these projects utilizing Confidential ’s documentation management system (Documentum).
• Utilized PUMA Methodology for validated document management along with Quality eDoc, SAP, TrackWise, DISC, INIT, NEXTS, Tririga.

Confidential, Swiftwater, PA

IS TECHNICAL WRITER

Responsibilities:

• Created, reviewed and updated existing validated quality documentation where applicable. Worked closely with the business analysts on the IS R&D team to develop documentation in support of IS projects.
• Deliverables include: user requirement specifications (URS), functional specifications (FS), design specifications (DS), validation reports, IS procedures (ISP) and test scripts, standard operating procedures (SOP), Trace Matrices, etc utilizing Confidential ’s documentation management system (Documentum).
• Utilized PUMA Methodology for validated document management along with Quality eDoc, SAP, TrackWise, DISC, INIT, NEXTS, Tririga.

Confidential, Wilkes-Barre, PA

SYSTEMS ENGINEER / SR .TECHNICAL WRITER

Responsibilities:

• design solutions, define functional, physical, operational, and data views, develop system testing strategies, develop concept of operations, transition and migration planning, and other tasks as directed or requested.
• Facilitate the Component Design Documents (CDD’s), the client review meetings, design and edit component design diagrams, the Strategic Plan, Execution Plan, Communications Process Plan.
• Managed the SharePoint site for the document management repository with the client.

Confidential, Hopewell, NJ

CRM BUSINESS ANALYST

Responsibilities:

• Facilitated and provided technical documentation for the conversion and implementation of SalesForce.com for the Confidential project.
• Authored and documented all procedures and processes of the data cleanup, conversion of .pst, SQL, .adb, .qbw, .dbf, .gm2 and .xls data and implementation of the software for the developers, tech team and business analysts.
• Authored and documented all procedures and processes for the end user training guide.