Sharon Lyons, Ms Email & Phone Number

Philadelphia, Pa, Us

Chalfont, Pennsylvania, United States

Otsuka PharmaceuticalWorking knowledge of Pharmaceutical Research and Development business areas such as Global Regulatory Affairs and the Generis CARA product. Knowledge of GxP processes. Assist with content related to system integrations/deliverables such as:Management of Functional/User Requirements Specification.Provide support to Testing Group for the Development and Execution of Test Cases/Runs.Setup and Support of User Acceptance Testing.Post-testing specifications document updates.Provide support for verification of migrated data.Complete gap analysis on system capabilities versus requirements as it relates to the system integrations.Interface with testing team to ensure requirements are testable as they relate to the system integrations.Assist with IT/Quality test execution as it relates to the system integrations.Assist architecture/IT team with any design or integration requirements.Knowledge of a regulated document review and approval system.Working in a fast-paced, team-based environment.

Merck - Upper Gwynedd

Provide stewardship and business analysis services for new GMSA global capabilities including: External Client Medical Portal and additional priority P&S Content Management and Consumption initiatives (as required)User access management in collaboration with IT, AMS, othersPrimary business point for assigned capabilities providing subject matter expertise on the system and process Partner with lead to manage operational governance process, backlog, etc.Partner with internal Business Owner and Learning & Development (where needed) to assist in developing training materials, executing resources, and conducting process and system training where needed.Continuous improvement of processes and systems, including stewardship processes (identify and leverage metrics to identify opportunities, implement improvements, and measure results, etc.)Lead on business side for business/systems requirements (represent/ensure appropriate business representation, ensure documented IT requirements and systems designs are aligned with and accurately reflect business requirements/needs, etc.)Assist with UAT activities for external Medical Portal (define UAT plan, develop UAT scenarios and test cases, identify and lead business UAT team, drive resolution of issues, complete UAT SDLC documentation, etc.)Partner with area leader and MedOps Comms team to develop and execute business Communication and/or Change Management plansEngage globally and cross-functionally in conducting stewardship and project responsibilitiesIn partnership with Client leads, Compliance, and Legal, ensure self, project and system adherence to applicable internal and external policies and procedures (e.g. Client SDLC, Global and local privacy, etc.)Experience partnering with business stakeholders and IT partners across geographies, therapy areas, and functions to inform global process and systems design and execution

Conshohocken, Pennsylvania, United States

Working across a number of application teams to help get consistency with how the brand is applied across various internal and external applications. Understand the intent and vision behind the overall brand strategy and work across brand, design, and development teams to ensure proper application of that branding to IT systems.Act as the primary point of contact for the rollout of branding to all company systems and technology.Work with development teams to scope and estimate branding changes.Work with Brand team, IT resources, and PMO to prioritize branding changes.Work closely with project manager to develop schedules, identify, and manage risks, maintain focus on project execution and delivery.Responsible for business analysis activities in accordance with the company's systems development methodology and supporting projects within a specific portfolio area (sales and marketing, supply chain, finance, etc.).Work independently or with other Portfolio associates to deliver small scale projects or deliverables for larger projects.Responsible for collecting, documenting, and confirming business requirements and functional specifications.Works in close collaboration with business partners and developers to ensure consistent understanding of business processes and requirements.Defines, develops, and delivers test plans and associated test case scenarios.Establishes effective relationships with other company and IT departments; builds and maintains effective business partner relationships.Assists with tasks and deliverables related to System Development Life Cycle phases for package and custom solutions.Attends and participates in user and project meetings and teams to expand knowledge; facilitates project status meetings; tracks project status.Investigates and documents project issues and detailed requirements.Frequently interacts with IT staff including business area management, portfolio managers, vendors, consultants and other contractors.

Greater Philadelphia

Serve as a liaison between business, vendor, and IT TeamsInterface with systems support and IT to address operational issues with Salesforce, Oracle, SAP, Middleware, Couriers, and Spotfire/Tableau- Data Analytics PlatformCreated Salesforce reports in order to identify data issues and verify successful data correctionsDrill down into root cause of production issues along with proposed solutions (technical and process)Document process steps and system enhancements required to support processLead process re-engineering workshops with business and IT stakeholdersSupport development of business and cases for new business capabilitiesWork alongside business groups to capture requirements and their pioritiesPerform impact assessment on new changing products capabilities, including impact to integrated (Boundary) systemsSupport future Salesforce custom application implementations and migrationsGather software specific requirements and draft SDLC documentsCoordinate testing of changes and enhancements with the business to ensure successful deliveryActively participate in the business analysis process and develop software, scripts, and ETLs to automate processes and adapt to changing needsDevelop interactive data visualizations using web-based technologies, Spotfire/Tableau or other visualization applications to drive insightful decision makingUse project-specific technologies to create custom applications to facilitate data integration and presentation, workflows, and reportingProvide application support and assist with application maintenanceParticipate in needed software configuration, documentation, and validation

Trevose, Pennsylvania, United States

Lannett Company, Inc.IT Application AnalystProvides support, engagement, and guidance to Lannett business stakeholders in managing execution of optimal process and system improvements in championing strategic objectives.Responsible for providing support for ongoing operations of business technology applications and drive new enhancements and improvements to the software platforms.Directs and oversee implementation of new technology applications across all functional areas ensuring user adoption and satisfaction.Knowledgeable in Quality Systems functionality and administration.Ability to think critically and strategically towards department mission and goals of the company.Actively contributes on Stakeholder and Client calls, and engages stakeholder for necessary inputs. Collaborates, leads, and drives discussions with the Business as an SME.Provides guidance with day-to-day administration of the application interfaces.Self-taught Microsoft Power BI as well as all supporting applications.Obtain business requirements.Analyzes and communicates application adoption issues, including problems with application functionality, data design and functional and technical software issues.Recommends alterations and enhancements to improve application optimization and availabilityTranslates business information needs into solution requirements. Educate and assist customers utilizing system tools to help drive reporting and collaboration needs as required. Strong analytical and product management skills including thorough understanding of how to interpret customer business needs and translate them into application and operational requirements.Take input from management and appropriately and accurately apply comments/feedback.Clearly articulate ideas and thoughts verbally.Accurately prepare written business correspondence that is coherent, grammatically correct, effective, and professional.

Plymouth Meeting

Technical writer.Creating/writing test protocols.Creating, writing, and updating functional requirement specifications and data description specifications documents.Running test protocols.Taking the test protocol through the SLDC and seeing it through to completion.Getting signatures and approvals of the test protocols.Working with the development team.Creating and importing documents into MIDAS, a Documentum, FirstDoc system. Creating, importing, and taking control of the documents and running them through the review, approval, and lifecycle process in MIDAS, a Documentum, FirstDoc system, as well outside of the MIDAS application.Creating the documents structure and up keeping that structure in MIDAS.Assisted users with MII application issues related to Java.Set up an audit process for users, access, and security of the MII application system.

Greater Philadelphia Area

Interface with the developers.Taking the business needs and requirements and translating them for the developers. Working on Ciboodle, a CRM Tool, that is being rolled out from 45 seats to 1000.Customer facing.Business finesse. Strong Technical writing experience. Level of knowledge of BA work, and working with CRM tools. "Writing to the blind" - most developers are offshore. Understands technicalities of code - JAVA, Object oriented code, and Ciboodle

Plymounth Meeting, Pa

Team Lead/Senior Business Analyst at Merck & Co., Inc.Objective: Support other BAs post migration, maintain their own worklists as well as support the PM on obtaining required status updates, answering questions around processes from other BAs, and identifying and resolving gaps/issues with the migration quickly. Works closely with other Paragon Team members.Team Lead for the Web Content Migration team.Create the project’s test plan.Create the checklist for testing and validating migrated web sites.Analyzing web sites and content.Using Tridion 2011 for web content migration.Publishing the data in Tridion 2011.Manually test and validate the migrated web sites.Create web page components using the Paragon Migration Tool into Tridion 2011.Create structures and publishing pages in Tridion 2011.Moving web page content manually in HTML in Tridion 2011.Creating structure groups and pages, linking the components to the pages, and publishing the pages in Tridion 2011.Has direct communications with end-users/clients Gathers, documents and organize requirements.Define, track and monitor performance metrics.Leads a 3-5 person teams and tracking progress/tasks for the team.Learns and follows business process - executes the process in a repeatable fashion.Understands business needs, business impact and recognizes issues, risks, exceptions etc.Track and analyze multiple work items through a repetitive process.Organized to keep track of worklist on multiple items in a very dynamic environment. Adaptive to changeIdentify issues, challenges, and take initiative to resolve before they occur.Quality checking other team members/direct reports work.Resolve issues quickly and strives to work under pressure.Understanding of content migrations and technology upgrade.Takes initiative to start and/or complete tasks.Defines and creates the teams’ process and ensures it is followed.

Analyze science, engineering, business, data technology processes, business workflow, and all other data processing issues for applications to electronic data processing systems.Analyze user requirements, procedures, and issues to automate or improve existing systems and review computer system capabilities, workflow, and scheduling limitations. Involved in quality assurance and validation testing. Performs user acceptance testing and testing fixes for reported software issues. Creates updates, and maintains release notes and user manuals for software releases.Worked with Sharepoint through the entire SDLC to assist customers with migrations and objectives.

Created process and operations documentation for all aspects of the business.Gathered all of the necessary requirements to create, facilitate, and document the security model process and to ensure quality compliancy.Facilitated requirements gathering from the users to expidite software fixes.Dealt with requirements gathering, user functionality, and process issues in this “Labeling” system.Tier II Support position that functions in a Production/Application Support role. Performed and operated similar to a Help Desk Technician, but at a higher level. Supported users over the phone for process, functionality, access rights, and technical issues within the Labeling System. Received calls or escalated issues, that may be something that could be troubleshot or give guidance to over the phone and solved the problem right then and there. Built an FAQ document for Training Groups, or potentially even did some light requirements gathering and writing for a development team to fix the issue. Supported Documentum, “Web Top Interface”, XML, and XML Editor. Worked with Documentum in regard to dealing with troubleshooting issues and User Access Rights. Possesses communication skills, the ability to put users at ease, and build a rapport. While there is not a lot of face-to-face interaction, there is this mindset and the role is very “customer focused.” Demonstrated the ability to be very organized, as well as, the ability to follow up with users they are supporting to make sure issues are resolved and the person is satisfied.Operated as the System Administrator.Knowledge of querying in DQL and API calls using Documentum’s Workspace, Samson, and Documentum Administrator.Responsible for User Access Review feeds and made the necessary compliant changes to the system.Possessed basic database knowledge and theory and use that knowledge and theory to acquire information about the Labeling system, tables, and user information.Customer focused.

Interfaced with the clinical team and assisted with there application issues and needs.Assisted with software installs, application administration, and testing duties.Identified, researched, and resolved application issues. Responded to telephone calls, email, and personal requests for technical support. Documented, tracked, and monitored problems to ensure a timely resolution. Demonstrated proficiencies in end user support, including excellent verbal and writing communication skills as well as organizational, troubleshooting, and problem solving skills. Interfaced with the business community. Wrote descriptions of technical problems, e.g. steps to duplicate and error messages, to be used by escalation resources. Supported Documentum products (Documentum Content Server, eRoom, Annotation Services, First Doc) with a strong knowledge of Documentum Administrator and DQL. Also responsible for supporting Cognos reporting. Provided training to the entire US staff and gave demo's to users. Examined the root cause and escalated issues with application vendor. Proactively understood issues end users struggle with and established a training / gap mitigation plan. Created and set up Tibotec to use the FDA Electronic Submission Gateway. Instrumental in figuring out the process and what is needed for using this gateway. Tested all of the components involved, purchasing the certificates, bringing the company live on the use of the gateway, as well as training everyone on its use. Supported users in their use and troubleshoot issues with ISI’s eCTDXPress via desktop and Citrix.

Interfaced with the clinical team and assisted with there application issues and needs.Supported CTMS and Medical Information systems which both utilized Siebel. Responsible for creating accounts, installing the application, troubleshooting, and testing scripts for upgrades on these systems. Assisted users with the usage, the understanding, and figuring out issues with these systems.Provided user and technical support for existing R&D Business Systems including EDMS, First Doc, Drug Safety, Quality Auditing, Medical Information Management including MSLs, Learning Management Systems, Clinical Trials Management Systems, Microsoft SharePoint Team Services, Portfolio management and other future systems. Customer focused support role within the R&D Business Systems team. Monitored all R&D Applications support email addresses and other sources of support calls, and responded quickly to resolve support issues. Provided support to user community via phone, e-mail, voicemail, remote control software, or walk-up consulting. Worked closely with the R&D Applications Support Managers in UK and US to ensure complete “Shire Working Day” support of critical systems. Liaison for the R&D System owners to anticipate key demand periods, for example NDA publishing, to ensure extended support is available when required. Assisted in the technical delivery of new R&D Business Systems or projects as required by the R&D Business Systems Function. Worked closely with the R&D Business Systems Function and the R&D System owners to deliver adequate training. Created and troubleshot SharePoint Team Services sites for users.Worked closely on SharePoint Team Services with the DBA to understand and resolve issues.

Centocor, Inc. (a division of Johnson & Johnson)Promotes and builds effective working relationships with IT staff and Business Partners. Responsible for documentation, as well as, excellent written and verbal communication skills that are reportable to all levels in the organization. Software development including reports, styles, formulas and resource algorithms. Unit and System testing including problem solving and system troubleshooting. Documentation of OPX2 System. Implementation Support for OPX2.

Acts as the communication between the Global Product Safety and the Information Systems departments. Speaks both the clinical and technical languages. Their system is comprised of Phase Forward’s Clintrace application used for front end adverse events tracking and an Oracle for the database application. Designs databases, queries, designs MedDRA guidelines and cases, looks and tracks data signals, data mining, and adhoc queries, using Microsoft’s Access all within the Post Marketing Database. Communicates and works within the Safety (Clinical) and IT departments. Troubleshoot and assist the department with their technical issues/concerns.

Served as a System Engineer providing support. Their system is comprised of Clinarium's ARISg application supplemented by a Microsoft Access-based custom reporting application, and a custom Web-based query tool. Maintained data integrity of 3 global adverse event databases. Designed and implemented changes to case report form processing workflow. Developed and enhanced reports using change management and testing procedures. Assessed the needs, gathered requirements, and developed new reports required by the safety team.Trained the safety team and co-workers on those developed and enhanced reports. Developed user and training manuals for these developed and enhanced reports.Provided user support for their publishing application system designed to facilitate New Drug Application submissions. It is Documentum 4i integrated with Xerox Dossier Publisher software, Core Dossier and Core Reports, which generates submissions and compound documents. This system supports the usage of Docutech printers, as well as, Adobe Acrobat.Ensured prompt resolution of support issues. Designed solutions for outstanding publishing issues, and troubleshot virtual document creation, versioning, annotating, routing, importing, and approval and security/permissions in Documentum. Monitored and troubleshot Publisher Rendition servers, as well as all aspects of this system. Involved in the system administration and troubleshooting of Documentum, Core Dossier, Adobe Acrobat, the Windows system, password, JAVA runtime, DFC Library, rendering, rendering queues, transformation, transformation servers, TOC, and reconciliation issues.

Software Engineer. Integrated client databases that supported clinical and financial research data. Used Cognos products, both Impromptu and PowerPlay, which included both client and Web versions to perform the integration's. Acquired instructor certification in Impromptu and PowerPlay. Conducted on-site training for the product line. Performed the installation, setup, and implementation of the products. Closely worked with clients to ensure a smooth integration. Utilized SQL*Plus in an Oracle, SQL Server, Sybase, Microsoft Access, and UNIX environment.

Software Engineer. Integrated database applications with Omnidex. Worked with relational databases Developed programs using SQL, SQL Server, Sybase, Access, Oracle, SQL*Plus, and DB2 mainly in UNIX environments.

As the team lead of five engineers, I coordinated, organized, and distributed the workflow. Held weekly staff meetings and provided training to staff, as required. Responsible for all paperwork and system change orders for all foxes. Ensured all fixes complied with FDA regulation guidelines. Served as a member of a front-end team to provide software support for laptops. The laptops utilized a custom Watcom database application for field data collection. The system ultimately consolidates data from international sites back to a UNIX based Oracle Data Warehouse. Isolated, identified, and resolved software problems in a fast-paced production environment. Resolved complex issues in-house, over the phone, via modem, and occasionally on-site in support of the clients and field staff. Performed relational database programming using SQL in a Windows operation environment.

Master'S Of Science, Instructional Technology

Activities and Societies: Assisted fellow students with computer issues.

Bachelor'S Of Arts, Psychology

Activities and Societies: Behavorial Science Society Minor in Sociology Recipient of W. W. Smith Scholarship