EXECUTIVE SUMMARY:

• Technical Writing, Training Programs, and BA and PM Information Technology work for Pharmaceutical, Chemical, Energy, Environmental Health & Safety, civil infrastructure and Telecommunications (MAN. WAN. LAN projects); included workflow and system process diagrams, procedures, manuals and explanatory documents for senior management and regulators
• Also experienced with research and writing from both threshold effect studies (environmental projects,) and toxicity approaches (safety - related litigation); research and author for Good Laboratory Practices; Pharmaceutical validation experience; familiar with Confidential standards-related database migration issues
• Developer and Instructor experience ranges from the basic Instructional Systems Development (ISD) and Task Analysis methods, to stand up instructor time, to digital media development. Writing and training experience covers industry and academia.

EXPERIENCE:

Confidential, Horsham, PA

Technical Writer

Responsibilities:

• Develop requirements and documentation for cell phone and crime statistics database systems.
• Refresh databases, develop and refresh wireframes. Respond to RFPs and write detailed bids and specifications.
• Develop analysis and plans for next generation 911 and multimedia-equipped network operations centers (NOC PSAPs cloud solutions & dedicated ESInet MPLS networks)

Engineer, writer

Confidential, Yardley, PA

Responsibilities:

• Manufacturing Execution System planning
• Plan and document manufacturing execution systems (MES) implementation for medical device manufacturer’s packaging retooling for the new California serialization requirements
• Global Medical Safety database and reporting systems replacement and integration of Clinical Trials Management System (among others),
• Work with sponsors and stakeholders to translate the business improvement vision into solid business requirements, support the Program Manager, attend or facilitate workshops and JAD sessions for the future state system, network operations, and roadmap.
• Collaborate to translate business to technical requirements (Visio flowcharting and /or UML) to take in subsidiaries, CRO's, external partners and regulatory agencies
• Extensive process analyses for interfaces for legacy systems of product databases, cloud solutions, clinical trial management systems, and regulatory dictionaries (Agile SDLC processes)
• Develop, explain and document cloud solutions for legacy system interfaces (inside and out of the company firewall,) data warehousing and ETL/EAI, and DR and business continuity The principal team member responsible:
• Documentation across all functions, Compliance/Validation, Information Asset Protection (IAPP,) Records Management, Architecture, Connectivity, Data Migration, Data Warehousing, Interfaces, Support, Disaster Recovery, and systems Retirement:

PM, editor and writer

Confidential, Horsham, PA

Responsibilities:

• Collate, proof and edit the bids and formal applications of several dozen client companies to secure “top-level domains” ( Confidential ) from the Internet Corporation for the Assignment of Names and Numbers; agile methodology with a waterfall deadline due to extreme confidentiality with applicants worldwide

Field Trainer\Technical Writer

Confidential, Philadelphia, PA

Responsibilities:

• Training courses, system and equipment descriptions and specs for all programs and materials that constituted the “deliverables” for client projects (computer applications, databases, communications systems, etc)
• Translate field operations into SOP’s and manuals
• In-house training and written materials for subcontractor work crews associated with telecommunication testing and installation projects.
• Wrote training materials and “toolbox” safety sessions for construction foremen and associated crews conduit rodding, operations for demarcations and telecom, equipment rooms, and support systems; SOP’s, Service level agreements; write or QC all work process and network documentation during testing and implementation
• Wireless Antenna projects for cell phone system reporting, Confidential locating technologies, database mining, RF models and tests for data from T-Mobile, Verizon, Cingular, Nextel & Sprint for the purposes of e911 state law implementation with local authorities (involved 2048 sites); writing for GIS applications and Confidential plans
• Installation and documentation of underground (subway) radio communications (RF engineering and mitigation testing)
• Emergency Call Box problem analysis and reporting: Regional state transportation authority arbitration ( Confidential ) with its vendor; resolution of public safety concerns and performance issues.
• Company voice-over-internet (VoIP) installation, implementation, maintenance, repair and documentation; Administration of Windows Server 2003 and 2008 R2 systems; configure SQL Server and IIS applications; design with Sharepoint Server 2007; setup of Linux PBX systems
• Translate data from field checks and operations of Land Use, Zoning, and ownership records for mass transit-oriented development (rail) and some wireless sites into documents for executive reports and decision-making
• 3D Architectural rendering (AutoCad, 3D Studio, Sketchup products) for civil construction to accompany written proposals
• Construction safety & environmental compliance for infrastructure construction projects write training materials and courses
• Development of city, county and state maps, analyses and reports from city, state and Census Bureau data using Confidential Products ArcMap 9.0-9.2, US EPA tools LandView, Confidential and OpenSource tool; write system documentation and manuals

Regulatory Compliance Training Manager

Confidential, Narberth, PA

Responsibilities:

• Design, write, edit test, deliver and evaluate all Environmental Health & Safety training required by federal, state, and local governments - for several dozen client companies; shop floor to corporate policies and procedures
• Regulatory-required, and additional managerial, and supervisor training courses and programs for client companies (generally those required by federal agencies
• Extensive experience in technical writing for business manuals, audit reports, official filings and reports, training materials, responses to employees, union and government officials, reports on research and responses to citations and legal arbitration.
• Design compliance programs, respond to citations, attend arbitrations, and conduct audits for chemical manufacturers, manufacturers of machined industrial products, food producers, food additive makers, cosmetic and fragrance makers, chemical producers, 2 medical device manufacturers, and consumer products and I&I distributors There were several dozen such client companies in the states mentioned above. The business model was retainer plus costs vs. hiring an in-house staff.
• Includes writing and delivering classes and on-the-job training in most OSHA 29CFR 1910, and 1926 topics including but not limited to: most General Industry section subjects such as RTK, EPCRA, Lockout/Tagout, Respirators, Machine Guards, Confined Spaces, Ergonomics, etc., as well as Confidential CDL, HAZMAT, and Drug & Alcohol requirements, waste management, process safety management, SARA Title III, Clean Air Act, Clean Water Act/NPDES, Oil Pollution Act and Spill Plans, state pesticide registrations under FIFRA, DEA Diversion Control, and GMP programs
• Extensive work (Training courses, auditing, some laboratory analyses, shipping papers and manifests) using 49 CFR 172.100 for several dozen manufacturers and trucking firms (MA to VA). Answer technical, label, placard, packaging and shipping paper questions on call for over-the-road, air (including IATA,) and rail shipping, Investigate incidents, respond to citations and represent clients at arbitration. Constructed overall, integrated emergency plans for facilities - taking in OSHA HAZWOPERS and PSM, EPA’s spills (OPA et. al.) Clean Air Act 112 (r) Risk Assessments and Confidential response (orange book)