Business Analyst / Technical Writer
7+ years Pharmaceutical Consulting Experience
BS Biology, MS Computer Science
10/2010 - present
Confidential, Morris Plains, NJ
Sr. Technical Writer- IT (EM) Enterprise Management SAP Integration Project
- Author and publisher of Right Answers Knowledge Based Articles (KBA) for online help for ServiceCenter analysts, system administrators and software developers.
- Translates logical/physical data designs and models into data dictionaries accessible by knowledge management software.
- Interface with SMEs including system architects, developers and users
- Support Right Answers Knowledge Management Team by working with clients to clearly identify, document, and analyze critical business needs - and support the team to translate these needs into knowledge community solutions
- Write SOPs, WIs, Job Aids for SAP integration
- Develop training for Business Objects Reporting, ITSM Scorecard, and SMARTS
- Research, write, maintain, and publish high-quality documentation and online content, KB Publisher, HTML/XML templates, and ensure material is accessible and available to customers
- Investigate customer and partner use cases, support statistics, and documentation usage metrics to focus priorities and develop documentation solutions
- Participate in all aspects of documentation development from product planning to rollout
- Provide UAT
- Coordinate hand-offs of the Enterprise materials to the internal Localization team
- Use SharePoint for document and project management
4/2010 - 9/2010
Confidential, Parsippany, NJ
Business Analyst: IT Finance - SAP
- Business process engineering, enterprise architecture diagrams using Visio
- Document processes; write AOPs and AOIs for rollout of SAP (FI/CO) implementation, ERP, ERS, BIP, and AMEX P-Card
- Develop online training including simulations using SAP Productivity Pak uPerform
- Analyze global business processes and procedures using Visio
- Enterprise business architecture, recommend new and/or improved processes
- Compile business requirements and translate into technical specifications
- Complete SAP configurations, for validation testing of final implementation
- Troubleshoot software and business problems, interface with developers, validation team and users
- Participate in projects to rollout SAP to new offices and perform enhancements to the business
7/2009 - 9/2009
Confidential, Rockaway, NJ
SAP Instructional Designer/ Developer: Consultant - Quality Control
Course development using SAP Agile uPerform eLearning software. Developer/ Instructional Designer for new courses develop content and revise existing courses.
Regulatory Course Development:
- Introduction to the FDA
- Introduction to GMPs, 21CFR211
- Good Documentation Practices
6/2008 - 5/2009
Sr. Medical Scientific Writer: Consultant- Confidential, Swiftwater, PA, Regulatory Affairs, Labeling
Development/ updating US Labeling documents (USPI, patient leaflet), CCDSs, Product Inserts (PIs) work with Labeling director to ensure compliance within the labeling sections, creation and updating of the CCDS\'s, assuring LCC process is completed properly, and preparing labeling submissions and responses to FDA.
- Excellent written and verbal communication skills (for native and non-native English speakers) with the ability to meet regulatory requirements and standards while maintaining effective relationships.
- Good understanding of regulatory agencies, industry practice, packaging manufacturing process, and the drug development process.
- Knowledge of Pharmacovigilance reports.
- ReviewCore Data Sheets CCDS and Safety Reports for consistency and potential need for updates.
- Good understanding of the labeling process and related issues in medical safety regulatory and corporate standards.
- Verify the content of labeling text, working collaboratively with members of the Labeling team to resolve issues to meetdeliverables.
- Write responses to FDA questions and review with SMEs to ensure accuracy.
- Leads and manages labeling projects CCDS, USPI, local labeling text effectively, with guidance by supervisor, through decision making, drafting, final approval, and local implementation.
- AttendGlobal Labeling meetings fordesignated products in clinical trials.
- Ability to handle multiple projects and prioritize work independently. Ability to assimilate clinical and scientific information, and present it in a concise manner.
Sr. Medical Scientific Writer: Consultant- Confidential, Swiftwater, PA, Global Clinical Immunology, Nucleic Acids Methods Platform for the Dengue Vaccine project
Lead team in medical writing for large project, including FDA submissions; coordinate and direct work of internal scientists on project. Papers include SOPs, SWIs, and other research papers for Dengue Vaccine Project. Responsible for the production of key documents related to CD & MA activities using document standards.
Documents written include study protocols, ICSR, Clinical Expert Reports, publications, technical reports, ISS, and ISE. Collaborated with other team members to ensure that the relevant function representatives produced appropriate sections according to specific needs of the project and nature of the documents. Co-ordinate input from subject expert contributors to these documents. Wrote GCI (Global Clinical Immunology) survey analysis, presentations and other writing as needed.
4/2007 - 6/2008
Confidential, Collegeville, PA
Sr. Validation Engineer, Consultant:
Global Product Conformance Team: RPI (Regulatory Product Information) ARISg project for the global consolidation of FDA data submission for drug approval.
Global Regulatory IT project experience (following FDA 21CFR Part 11):
- Technical/ Scientific Writing (Regulatory): IT SOPs, SWIs, business process modeling for use cases (using Visual Paradigm) and infrastructure architecture for global data migration to ARIS Register (used for drug product registrations), New Drug Application, Investigational New Drugs and Clinical Data Management. Use Documentum including EDMS and EDMSR.
- Develop SharePoint site for project and document collaboration.
- IT Validation Testing: Including IQ, OQ, PQ validation script writing and testing. Usability testing, discrepancy reporting and tracking. Use Active Directory for user permissions.
- Instructional Designer/Developer:Project Manager for creating the instructional materials for global certification program for Wyeth ARIS Register application, developing content for student manual, online user guide and help using RoboHelp, Visio, Adobe Captivate, Articulate, Flash, Photoshop, SoundBooth and PowerPoint.
9/2005 - 2/2007
Confidential, Swiftwater, PA, Communications Department
- Project Manager for development of the Strategic Pandemic Preparedness Plan (PPP) and Pandemic Response Plan (PRP) for Continuity of Operations for Sanofi Pasteur Swiftwater, PA site.
- Instructional Design and Development of pandemic training materials for all employees including: Pandemic 101 class in collaboration with Medical Affairs, Human Resources, Health Safety and the Environment, Communications, Security, Industrial Operations, Sales and Marketing departments. Conduct pilot for program and assess for revisions and launch. Use of PowerPoint, AuthorIt, Brainshark, Photoshop, Articulate and other Adobe software.
- Develop/implement a Pandemic Awareness Day event, write all supporting materials documentation including informational materials for attendees, surveys, posters, write speeches, prepare presentations, and plan graphics with agency.
- Design and develop information architecture, strategy and functional prototypes for "Pandemic Information Center" Website.
- Responsible for working with key US business units in developing, maintaining and testing of business continuity plans. Responsible for performing or coordinating all aspects of pandemic contingency including budget requirements, document and report status\' of meetings and activities, create and monitor tasks and issues for pandemic activities as lead project manager.
Sr. Validation Technical Writer: Confidential, Swiftwater, PA, Information Technology
SAW project - test script writer, medical instrumentation, technical writing for SOPs and SWIs for IT department.
Sr. Medical/ Scientific Writer: Consultant - Confidential, Swiftwater, PA
Medical technical writing, SOPs, SWIs, Master Specifications, CMCs-Chemical manufacturing documents, medical technical writing as required.
4/99 - 8/05
Confidential, Livingston, NJ,
Sr. Web Master/ Information Architect, Enterprise Services:
Project lead and information and infrastructure architect for development of Enterprise Services, Security, firewall, Solaris Unix, Peregrine Services, Oracle and Global Telecom Intranet using Vignette products. Other responsibilities included technical writing for enterprise IT standards, development of Sharepoint sites, product recommendation papers, business cases, weekly, monthly and quarterly department project status reports, firewall performance analysis charts, Visio process diagrams for network and firewall. Creation and updating all department project plans for Enterprise Services. Use of ITIL standards framework for best practices.
- Primary architect, designer/ developer, and maintainer of a global support Intranet site.
- Project Management for Enterprise Services projects using CA Unicenter.
- Responsible for writing global network infrastructure architecture standards.
- Interface with senior management, SMEs including application and infrastructure architects and users.
- Daily change control meetings.
- Business case development for projects and upgrades.
- UML modeling for software and system engineering diagrams (Rational Rose).
- Use Active Directory for software deployment, storing security access permissions, printer and computer info etc.
- User Interface Design, usability testing for network infrastructure, site development and modifications.
- Responsible for Enterprise Management standards including UNIX, HP Server standards, Server Naming, CA Agents Server Standard, Vignette application development, server security and white papers.
- Write technical documentation, runbooks and procedures based on input from management, programmers, systems and database administrators.
- Information architecture: Analyze and categorize information and develop documentation for management infrastructure.
- Develop and maintain technical standards and procedures for Enterprise Service Center.
- Software Quality Assurance (QA) and validation testing experience with a wide variety of projects and environments. Functionality, compatibility, reliability, exploratory/ad hoc, load/stress, usability, installation, security and related test methodologies. Testing of web application, client-server, network, multimedia, database, educational and related projects for Windows, and Solaris Unix operating systems. Creation and execution of QA and testing processes, test strategies and plans.
- Use SharePoint, as Web-based collaborative tool and other typical system administrative activities such as site creation, user training, performance analysis, and issue resolution.
- American International Group, Global Enterprise Service Center, Sr. Webmaster/Web Developer for the AIG global network/server support Intranet.
- CTO SWAT Team for large scale technology problems.
- Provide web site architecture, information design and GU design and development.
- Firewall and security evaluation.
- Writing technology standards for UNIX, Windows, Security, and other software products such as Vignette, Adobe products and ColdFusion.
- Provide leadership and support in information management and project delivery while ensuring that business applications effectively integrate with enterprise information architectures.
- Promote the benefits of data modeling, metadata, and model management.
- Develop and maintain the Enterprise Information Models and Common Data Architecture for the Corporation as driven by the business strategy.
- Maintain the deliverables of the Common Data Architecture and the Global Information Support Services infrastructure.
- Consult on information management projects to ensure they meet information strategy and architecture design.
- Conduct usability studies for existing site for transition to new site design and implementation.
Confidential, New York, NY
Sr. Technical Trainer: 4/1998 - 2/1999
Consultant for technical training and instructional design using the Vignette web development and content management application for large scale enterprise solutions, nationally and internationally.
Confidential, New York NY
Customer Training Specialist:1/1997 - 2/1998
Technical trainer teaching Solaris UNIX System Administration, nationally. Certified Solaris System Administrator.
Unix/Solaris (certified Solaris System Administrator), Linux, Windows
- Graduate School of Engineering
- Instructional Design ¾ finished
- MS in Computer Science, BS in Biology