SUMMARY:

• I'm naturally energized, self - motivated, confident, extremely creative, and results driven (solutions vs. reactionally reckless). The optimist in me believes that there are no problems that cannot be solved.
• I possess superior communication skills, and thrive in the client-facing, stakeholder engagement, vendor relations arena. Drives negotiations from initial contact through satisfaction of objective.
• I thrive in challenging environments - Consent Decree at J&J 2012 and Cyber Attack. at Confidential 2017.
• Focus - Implementation and integration of GXP, Regulated software systems, Acquisitions, Consent Decree, Quality Improvements, Change Management initiatives, Content and Data migrations, ETL, Web/Cloud, and Mobile applications and other emerging technology used across the Global community.
• Thrives in both a Waterfall or Agile environment, Six Sigma knowledgeable, and always seeks to deliver optimal quality and make budget friendly decisions that ensure project success. Develops and manages all project related material, including project plan/schedule, resource plan, requirements, use cases, user stories, and more.
• Extremely knowledge with using various Federal regulations as a foundation for developing software (21 CFR, GXP, cGMP (Current Good Manufacturing Practices...), uses GAMP5 risk-based approach, and manages the development of Compliance and Validation, CSV deliverables (protocols (IQ, OQ, PQ), Leads the change control process for the development of new or the enhancement of existing software, products and/or processes.
• Facilitates project planning and daily status call meetings for cross-functional teams to ensure tasks are being completed according to project schedule (milestones, issues, risks, budget and resources concerns). Monitors and controls project progress, and provides visibility on it by presenting dashboard to the Project Steering Committee and Sr. Management.

TECHNICAL SKILLS:

• Microsoft Office, Google Analytics - Business Intelligence and analytics Compliance
• Wire, SharePoint 2016, Visio, Track Wise, NextDocs eTMF
• InSight Veeva Vault, ETQ, MS Project, Acrobat, ETQ, JIRA, Requisite Pro
• Quality Ctr., Documentum Webtop, HTML; JavaScript, XML, Captiva, Arbotext, Ariba
• Dreamweaver, CSS, Adobe Creative Suite, Plateau/Success Factors, JD Edwards 9.1
• SAP, Oracle, SQL, Rally, Windows 10, MAC, Web APIs, Cognos, Power Designer
• Confluence, Data and Content Migrations, ETL
• AWS, Microsoft, and Google Cloud platforms

PROFESSIONAL EXPERIENCE:

Confidential

Project Lead and Senior Business Systems Analyst

Responsibilities:

• Lead Technical analyst facilitating workshops to define requirements for the implementation of VAULT eTMF.
• Lead Technical analyst and functional area Change Consultant for the upgrade implementation of ORION - Confidential 's Product Registration and Submissions tool.
• Manage deep-dive analysis of IDMP data elements to determine company’s readiness to support EU’s future IDMP regulation (controlled vocabulary, CV analysis. Understand and document current and future states for gap analysis, change control documents, and requirements for harmonizing vocabularies across Regulatory.

Confidential

Project Lead and Senior Business Systems Analyst

Responsibilities:

• Build a project scope for the product swap between Sanofi and Boheringer - Identify and assess risks (including staffing, budget, scope, etc.), as well as produce and execute proper mitigation strategies to minimize risks.
• Consults across all Regulatory information management, therapeutic and functional areas on all aspects of operating model, process, information and technology. Formulates information management solutions.
• Proactively assesses the needs of perspective clients from meetings, conferences, research and business groups. Seeks out novel approaches to meet those needs.
• Provides vision and direction of new technologies and/or processes to increase client value.
• Serves as liaison to senior leadership to develop information management strategies and to communicate perceived opportunities to improve business processes through integration, new technologies /other initiatives.
• Determines technical system and procedural needs, and develops approach to meeting these needs.
• Oversees all aspects of process, information and/or technology implementations
• Provides senior level project leadership; with broad industry perspective, technology direction and process improvement. Participates in and conducts long-range project planning.
• Coaches and mentors junior staff in client relationship building and information management tools and concepts.

Confidential

Senior Business Systems Analyst

Responsibilities:

• Implemented NextDocs’ eTMF across the global Clinical Trials Division - Analyze data elements and map from multiple legacy systems to source solution, capture user stories and transpose them into use cases.
• Defined system specifications for system configurations. Defined and consolidated clinical artifacts and metadata so it aligned with the DIA Model and across clinical trial phases and functional areas.
• Develop team SharePoint sites as an interim location to ensure Regulatory business groups consistently developed submissions data before deployment to target system - grant site access to users, collect data for reporting to management, and play a lead role in information classification and management - ensure a full understanding of what information existed, where it's located and what the current version is.
• Facilitated meetings to capture and document the gap analysis and functional risk assessment, brainstorm with teams on process improvement efforts. Participated in integration, discussions with cross functional teams.
• Developed system validation deliverables (IQ, OQ, PQs), along with applicable project related documentation.

Confidential

Senior Business Systems Analyst

Responsibilities:

• Lead role in conducting workshops to capture requirements for building a Reservation application in JD Edwards (ERP) - Primary objective was to implement a product for reserving surgical kits for hospitals serviced by the Spine Division, similar to an existing application being used by the Trauma Division. Benefits - increase the use of existing inventory by 2% per year beginning in 2015 and enhance the process for delivering surgery kits to hospitals by increasing usage of $382K of existing inventory and allow virtual return of kits.
• Authoring Validation documents in collaboration with SMEs and the technical team, transposed customer needs into user and functional requirements, and liaise with tech team in the development of system requirements specifications. Constructed test scripts that validate that the solution conforms to requirements and are aligned with the traceability document . Facilitated UAT; documented test defect report.
• Configured JD Edwards’s enhancements to align them with system requirements.
• Facilitated meetings to collaborate with team members, customers and stakeholders to establish the technical vision and analyze tradeoffs between usability and performance needs throughout the lifecycle of the project.
• Collected the necessary details for change request submission, authored SOPs, Work Instructions, and managed approval and submissions to Documentum for controlled documents.

Confidential

Sr. Systems Analyst

Responsibilities:

• Engaged clients to review existing content, discuss migration schedule, provide a preliminary overview of SharePoint Team sites, and to introduce project direction on developing metadata, document properties, versioning and more. Also provided direction for final content health - such as security, version control, content lifecycles, workflows, categorization, search, properties, and metadata.
• Facilitated user acceptance testing for user groups to ensure the integrity of the integration with other tools and migration from source to target repositories. Created test scripts and facilitated UAT, completed applicable test reports and validation documentation. Collaborated with technical teams to resolve systems errors and fix bugs.
• Consulted with technical trainers and SMEs to make suggestions on improving the quality of work Instructions, and improve functional processes. Also developed work Instructions and material. Managed the change control process throughout implementation.

Confidential

Senior Technical Business Analyst

Responsibilities:

• Participated in planning meetings to create solutions for completing deliverables listed on the FDA Work Plan.
• Conduct research and Collaborated with other consumer product divisions to capture existing ETQ functionality
• Collaborated with user groups to capture requirements and provide coaching to encourage setting realistic goals that would align with the objectives set by the management team for ETQ.
• Managed the communication between the technical team and business lines throughout system development, assisted in configuring the system's user interface, workflow, and security processes.
• Lead role in approving CSV documentation and ensuring that all SDLC documents aligned with validation processes - Validation Plan, System Requirements, Test Protocols (IQs, OQs, PQs), and Validation Summary.
• Leadership role in the development of the ETQ program and course content, and Train the Trainer.
• Facilitated UAT sessions, documented defects, and managed testers and testing schedule throughout.

Confidential

Senior Business Analyst

Responsibilities:

• Consult with business leads to capture requirements to ensure success of data migration.
• Developed project scope, requirements and system specifications, built data migration mapping specifications/ taxonomy to ensure appropriate configuration of properties, metadata, and workflows prior to migration.
• Collaborated with technical team to ensure success of migration into development, quality and production.
• Managed the development of SharePoint portals that functional areas used as an interim data repository which allowed an opportunity to cleanse data prior to migration. Used SQL to retrieve large dataset for analyzing, and building reports. Automated processes where possible to allow self-management for project tasks.

Confidential

Sr. Business Systems Analyst

Responsibilities:

• Call Center Consolidation Project - Conducted group workshops to document end to end processes for 3-existing call centers with similar or duplicate processes. Final analysis resulted in $250,000.00 savings for J&J.
• SDLC Projects - Contributor in product development sessions, conducted product research, analyzed and documented results, facilitate planning sessions with stakeholders to understand business objectives and build project scope (identified gaps and recommended solutions). 1. Mobile apps 2. Virtual meeting application (reduced travel expense by 35%). 3. Knowledge base (consolidated 100s of intranet sites).
• Developed requirements for future releases, contributed to the research, system configurations and GUI design sessions for new products, managed UAT efforts - author, approve, and execute test scripts.
• Web Development - Managed the change control and publishing approval process for drug content changes (e.g. Label updates, drug history...), and Documentum releases for Medversation.com.
• Managed off-shore team, quality and technical teams during system release - bug fixes, smoke testing, site map issues, crawl errors, and search and fetch anomalies.
• Used Google Analytics to translate analytical data from website, used results to create metric reports

Confidential

Quality Business Systems Analyst/Technical Trainer

Responsibilities:

• Conduct workshops to capture requirements for existing and go forward business process for managing documents and to develop a plan for fulfilling objectives that would ensure a healthy migration.
• Manage the creation of migration specifications / taxonomy, analyzed data, scheduled migrations and assisted each group with resolving any migration and integration issues thorough release of application and Hypercare.
• Managed deliverables for 3 analysts and SMEs from more than 10 functional areas during implementation.
• Constructed test scripts and facilitated UAT. Consult with vendor to resolve functionality issues.
• Lead role for the instructional design and development of the web-based and classroom programs.
• Played a pivotal role in authoring the Enterprise taxonomy and quality policy documents.
• ETQ technical for SMEs and 100s of end-users - class sizes averaged 25-40 students.
• Controlled project costs by suggesting configurations vs. customizations, managed timelines, provided project status updates, and aanalyzed data and prepared mapping specs and configuration sheets prior to migration.