Summary of Experience

• Combined Experience as: Senior Business Analyst Business / Stakeholder Requirements, Non-Functional / Functional, Security Metrics , Technical Writer, IT Project Manager, Clinical Trial Project Administrator, Project Planner, Script Writer, Proofreader, Clinical Executive Assistant, Clinical Trial Data Management Support Associate, Project Coordinator, Project Support, RFP Writer, Regulatory Affairs Specialist, Human Resources.
• I utilize my excellent verbal and written, negotiator, and leadership skills, to work with business executives. Conduct research into a wide range of computing issues as required. Absorb and retain information quickly, specifically complex technical information. Analyze targeted audiences to create, write, and assimilate detailed and accurate business requirements. Translate work in a concise, effective and user friendly language especially technical material for presentations, user guides, manuals, etc. . Ability to make documentation templates straight forward and easy to read even for end users . Good understanding of organization's goals/objectives. Highly self motivated unique individual, excellent time management and organizational skills. Proven analytical and problem-solving skills, which give me the sense of project ownership with the ability to prioritize, manage multiple assignments, responsibilities, and execute tasks in a high pressured environment. I have excelled in every position I have held, as my mindset is to seek solutions.

Proficiency Technical Skills

Business Acumen

• QA Analysis and Testing, Script Writing, Information Protection and Risk Management IPRM , Data Warehouse, ITIL Information Technology Infrastructure Library , SDLC System Development Life Cycle Waterfall Model Requirement gathering and analysis, Design, Implementation, Testing, Deployment, and Maintenance , Adhere to Project Life Cycle Methodology, COBIT Control Objectives for Information and Related Technology , Help Desk, Firewall, Data Power, Intrusion Prevention System, Q Radar , Identity and Access Management including, IBM SIM/SAM, Active Directory, eDirectory, Single Sign On, ACF2 Access Control Facility Security, Anti-Virus, Internet Filtering, VPN Virtual Personal Network Remote Access, Risk Management, Investigations and Forensics, Security Awareness Program, Federal Information Processing Standard FIPS Compliance, HIPAA Health Insurance Portability and Accountability Act , Encryption, Social Security Administration SSA , Payment Card Industry PCI , Federal Taxpayer Information FTI and , Mobile Internet Communications Asset MICA . KBA Input Processing Knowledge Based Process Articles , IMS Identity Management System , Subject Matter Experts SMEs , GNOSIS Pfizer Documentum Repository , PDOCS Pfizer Document Management System , SnagIt, and e-Signature. GDMS Data, SED, PC Portal, GIDM Registration, HR Source/Technology Documents, RAPID Access Portal , Installed RSASecureID's, and gRAS, GRIP, GRPM, and SQL Navigator4.
• PRISM, NIHClinicalTrials.gov, IRIS International Regulatory Information System , ISI Toolbox submission compliance documentation of regulatory guidelines , ISI Publisher publishing regulatory submissions , TransparentCT, ESF Electronic Study File , and Clinical Trial Disclosure. SOPs Standard Operating Procedures , ICH-GCPs, FDA Food Drug Administration guidelines, and regulations, ICD Coding. Oracle Clinical, FFRS Field Force Roster System , Oracle Warehouse Inventory, eCTD Format for Electronic Submissions , EDI Electronic Data Interchange , Oracle e-Business Suite EBS , Oracle Human Resource Management System HMRS and, Oracle Procurement. Good Laboratory Practices, ClinRepGCDSTrack, Documentum, Impact, Business Objects, PD Portal, and CMP tools, and AMA style.
• Proposal Writing, Proposal Content, RFP Request for Proposal RFI Request for Information , streamlined, responded to inquires, created tracking of all RFP's to completion. Windows 2010, Windows NT, SharePoint 2010/2013, Microsoft: Word, Excel, Access, Power Point, Project, Publisher, OneNote, Visio, InfoPath, and Outlook . Pub Med, Document Library, Endnotes, SAP, B2B, Vinet, Elara, and Right Track. UNIX, Internet Lotus Notes, Thunderbird , Sametime, and Infoshare, WebEx, Live Meeting, NetMeeting, Ariba and, Right fax. SQL Navigator4, MIMS, Colt, Budget Wizard Reporting, Crystal Reporting, Trackwise, Page Maker, eAccess, eRoom, Eclipse, Acrobat Reader/Writer marking up pdfs , FedEx, CWT, SABRE, and E-ticketing domestic, international , Training Programs and, Event Planning.

Professional Experience

Confidential Business Analyst Contract Ended

• Interviewed / Analyze Business users, Stakeholders Analysis.
• Collaborated with Clinical Research to accommodate to New Business Requirements.
• Developed Business Use Cases, Stakeholder, Business and Non-Functional / Functional Requirements.
• Worked with Analytics team to document New Reporting Requirements.
• Assessed the current system documentation for the Clinical Research Collaborations CRC System and provide recommendations for consolidating and updating the existing system documentation.
• Documented Requirements/updated all relative SDLC documents with new Requirements/functionality for applications.
• Completed Design, Design Specification and Design Verification deliverables, and Security Metrics.

Confidential

Business Analyst / Technical Writer Contract Ended

• Adhered to the SDLC Waterfall Model to build documentation utilizing Strategic planning, Business model analysis, Process design, and Systems analysis , and assisted Integration and Testing of New Solutions on the framework for SharePoint upgrade 2010 to 2013.
• Analyzed IT Project Requirements to determine types of documents needed. Developed project plans and timelines. Planned, designed, researched, wrote, and edited a range of documents, including user guides and manuals, technical specifications, training materials, user policies, and proposals, for both print and online media.
• Collaborated with project teams to collect, interpret technical information, and documented prepared documentation for the specific project SharePoint 2013 Upgrade DMZ Internal Plan, Validation /Verification Plan, User Requirement Specifications, IQ Testing, Configuration Specification, Test Protocols, Architecture Design Specifications, Disaster Recovery Plans, Summary Reports and Traceability Matrix .
• Developed high-quality, scientifically, technical sound communication pieces for our clients through timely and substantive accurate editing, styling/formatting of documents, and proofreading, of publications, presentations, and multimedia tools.
• Tracked and communicate report project status throughout the development process.
• Obtained approvals, e-Signatures, and Business Technology number for PDOCS Pfizer Document Management System .
• Uploaded documents into SharePoint and GNOSIS Pfizer repository databases .
• Incorporated a glossary, acronyms and local jargon for Pfizer's Business Technology glossary for all terminology related to BT Business Technology , called Wordology.

Confidential

Business Analyst / Technical Writer Contract Ended

• Analyzed, transformed, resolved, and an assisted with the implementation and ongoing support of the Health Insurance Exchange HIX environments utilizing Strategic planning, Business model analysis, Process design, and Systems analysis .
• Collaborated with BEST IT Security Division IT Manager and worked closely with the HIX Project Manager, as well as staff from Security, Network, Application Hosting, Data Center and Database Divisions.
• Worked with Information Technology and Security to improve the quality of the services being delivered, for the project.
• Processed design and documentation for the diverse audiences, documentation of IT Support Service technical procedures. Prepare/Edit computer validation documents Validation Plans, User Requirements, Configuration Specification, Test Protocols, Summary Reports, and Disaster Recovery Plans .
• Incorporated a glossary of business terms and local jargon.
• Incorporated Data flow diagrams to illustrate how data flows through the information systems different from flowcharts depicting algorithmic flow of business activities .
• Facilitated and documented the process design reviews, Detailed process flows and Standard Operating Procedures SOP's , Created training materials for the technical staff for learning of the Standard Operating Procedures SOP's .

Self Learning

Maintained skills via online training classes to keep current on software applications.

Confidential

Senior Business Analyst / Technical Writer Contract Ended

• Led technical documentation including System Development Life Cycle SDLC - Waterfall Model /Adhere to Project Life Cycle Methodology, Standard Operating Procedures SOPs , User Guides, System Support Guides, proofread, test scripts and project tracking matrices utilizing Strategic planning, Business model analysis, Process design, and Systems analysis .
• Worked with Information Technology to improve the quality of the services being delivered.
• Tracked completion of Information Technology Help Desk Tickets, and followed up with clients on results and close outs.
• Facilitated process for cross functional groups, SMEs subject matter experts , and all relevant stakeholders on project supported such as process flow design diagrams, Functional Requirements gathering, and analysis.
• Translated all Business Requirements into System Functional Specification and System Design Specification to support New Business Requirements. Configurations of workflows, design of forms, create reports.
• Responsible for project plan updates, implemented into Knowledge Base Articles KBAs , and tracked in a common Document Share System SharePoint .

Confidential

IT Project Manager Contract Ended

• Collaborated with the Global Outsourcing Management Team, Regulatory, and Technical Writing Groups.
• Initial setup of Pfizer computers for all users throughout varies countries.
• Liaison with Security and department within the operation of On Boarding and revising policies for varies countries.
• Installation of RSASecureID's, and gRAS on all Pfizer computers.
• Utilized Oracle E-Business Suite Modules - Oracle Identity Management System , Identity Access Management , and Oracle Procurement of required hardware and accessories for external resources so that they can complete their business objectives. Submitted access requests to Pfizer secure systems for new external resources.
• Shipped/Tracked On Boarding /Off Boarding computers throughout varies countries along with user guide upon receiving.

Confidential

Clinical Trial Project Administrator / Planner / Script Writer / Proofreader Contract Ended

• Monitored CTD website for errors, responded to all RFI Request for Information , tracked, and worked with GSS to resolve and run reports. Proofread and script wrote post clinical trial results/data to the PhRMA website for public viewing.
• Assessed scientific data to problem solve complex issues on data presentation, and to recommended presentation options.
• Uploaded approval letters to ClinicalTrailas.gov for Non-IND trials. Import approved CTDB registration forms into ESF.
• Ran IRIS International Regulatory Information System reports for protocol serial numbers.

Self Learning

Since my last contracted position ended at BMS, I had been keeping up my skills in taking on line training classes to keep current on software applications for future employment.

Confidential

Clinical Executive Assistant / Project Planning Contract Ended

• Effectively supported two Group Directors' Alzheimer's Disease, Depression, and Autism Programs.
• Successfully proofread, and negotiated legal agreements consultant and confidentiality Proposal Writing, Proposal Content utilized RFP/RFI process and tracked. Knowledgeable with Oracle E-Business Suite Modules Oracle Contracts , vendor files, and payments utilized Oracle E-Business Suite Modules Oracle Procurement .
• Maintained financial budget for three departments in the global research area.

Confidential

Project Coordinator / Executive Assistant Contract Ended

• Effectively supported President of Northeast Utilities Enterprises / Select Energy / Select Energy Contracting, Inc. / NGS Acquisitions, Inc., Mechanical, Inc., and Northeast Generation Services Company.
• Collaborated with managers of Project Bidding and Deal Origination New England utilized Oracle E-Business Suite Modules Oracle Procurement .
• Served Assistant General Counsel and a team of four attorneys.
• Adhered to standards and guidelines of the Treasury System Development Life Cycle SDLC / Adhere to Project Life Cycle Methodology. Coordinated SEC, NYSE and various court filings, engaged in close involvement with clients and other company employees.
• Worked with Human Resources utilizing Oracle Human Resource Management System HMRS with performance reviews, and compensation adjustments, Worked with Legal on Proposal Writing, Proposal Content for stay letters, and the divestiture of Select Energy. Responded to all RFI Request for Information , composed own tracking to completion.

Confidential

Clinical Trial Data Management Support Associate Contract Ended

• Data management of records related to Pfizer's ongoing Phase I, II, and III clinical programs. Utilizing IRIS International
• Regulatory Information System , ISI Toolbox for submission compliance documentation of regulatory guidelines , ISI Publisher publishing regulatory submissions , and ESF Electronic Study File , Clinical Trial Disclosure.
• Submittals of Protocols, IND's, Investigator Brochure's, IRBs Institutional Review Board , ICDs to NAMG vendors,
• Assured documentation was in compliance with FDA regulations, Site files, FDA 1572, Informed consents, Drug Safety Reporting.

Confidential

Clinical Project Associate / Regulatory Affairs Specialist / Executive Assistance Divesture/Relocated NC

• Instrumental w/Divesture Transition, changing Bayer systems to Talecris, worked closely with Legal Human Resources
• with performance reviews, compensation adjustments, and stay letters.
• Collaborated with the following positions throughout my tenure in the departments of Oncology, Hemophilia, Neurology, and

Pulmonary:

• Confidential Commercial Operations, National Director of Sales, National Sales Managers, National Account Managers, National Sales Force Reps for Plasma, Operations Manager, Associate Director of Scientific Affairs, Directors' Global Clinical Project Leaders, and Senior Vice President.
• Successfully managed several 10m budgets utilized Oracle E-Business Suite Modules Oracle Procurement , including, but
• not limited to, reviewing, and processing of all invoices, disbursement requisitions, and expense reports.
• Ensured compliance on all submissions in preparation of clinical data to regulatory documentation for the biological licensing
• applications, clinical grants, and ensured compliance. RFP Writer Request for Proposal RFI Request for Information , Proposal Writing, Proposal Content for Legal contracts for US Nurses, Vendors, Travel, SAP, streamlined, responded to inquires, and created tracking of all RFP's to completion.
• Utilized IRIS International Regulatory Information System , ISI Toolbox for submission compliance documentation of
• regulatory guidelines , ISI Publisher publishing regulatory submissions , and ESF Electronic Study File .
• Managed Regulatory Document Files Managing Investigator Sites Files, Form FDA 1572, Informed Consents, Clinical Trial
• Protocols and Amendments, Institutional Review Board IRB document Files, Source Data/Documents, Study Drug Management, Drug Safety Reporting utilizing Trackwise , Crystal Reporting, and SAE's Serious Adverse Reports , created study start-ups and drug shipment.
• Managed/Directed supply/re-supply of study drug shipment to investigational sites, reviewed, processed CRO, CTAs
• mastery of relevant systems e.g. Impact, Business Objects, Study management tools, ESF, etc. , and study payment requests. Interfaced with vendors on ordering of non-drug study supplies as needed.
• Preparation/Publishing of non-clinical, study reports, and regulatory document, e.g., INDs CTAs, CTDs, and reports of
• studies. Preparation of templates for study reports and other regulatory documents, coordination of activities and processes within business units, activities associated with maintenance and use of global DM P document management system. Archived in Trial Master File TMF all study documents, revisions, and additions on a continuous basis, in accordance with departmental SOPs.
• Experienced in Oracle Human Resource Management System HMRS for Onboarding New Employees, Oracle Identity
• Management System, and Identity Access Management, and Oracle Warehouse Inventory.

Confidential

Coordinator/Records Manager / ICD Coding

• Liaison between many physicians, patients, and managed care, along with the insurance companies, commissioners, workers compensation, and attorneys .
• Organized patient, surgical schedules, insurance verification, and follow up visits.

Confidential

Medical Transcription PT Evenings

Transcribed dictation from a Lainer Voice Write Ex Dictation System as well as from a regular dictation machine. Generated reports such as specimen, surgical pathology, cytology, autopsy, and electron microscopy, special procedures, outreach, and consults .