SUMMARY

Experienced Senior Business Process Analyst/Documentation Specialist/ Writer and Information Technology Engineer with 10+ years with Fortune 500 Pharma, Information Technologies, Telecommunications, SDLC, Regulatory, Medical, Marketing, and Business industries. Experienced FDA CFR Part II, business process analysis, Marketing and data analytics, technical writing, SDLC, SAP, data analysis, information technology, knowledge engineering, content management, promotional marketing review, and business operations in the pharmaceutical and business industry.

EXPERIENCE

Confidential Bridgewater, NJ

Senior Business Process Analyst/Documentation Specialist

• Developed SOPs in Pharma logistics, clinical mobile web applications, business operations, shipping, and delivering.
• Performed business process analysis, GAP analysis, developed and wrote SOPs and Methods & Procedures for compliance under FDA CFR Part II for system tracking, product ordering, and delivery and shipping.

Confidential Raritan, NJ

Senior Process Analyst/Consultant 2011

• For Confidential Information Technology Web Data Mobile Security Protection initiative, mapped Infrastructure and Web Application business processes, wrote and developed Infrastructure documentation, compliance plans, technical Operating Model, work instructions, project charters, management plans, overseeing all aspects of SDLC.
• Worked with subject matter experts and management coordinating business process reviews, developed Visio ‘As Is’ and ‘To Be’ system workflows as part of SDLC methodologies (Agile, Waterfall, RAD) and adherence to 21 CFR Part 11, SOX, GXP, and J&J global web compliance initiatives.
• Familiar with SDLC compliance project work streams, Waterfall, Agile, SCRUM. Successfully completed required compliance corporate training initiatives.

Confidential, Bridgewater, NJ

Senior Business Process Analyst/Content Developer

• Performed Process Mapping, GAP Analysis and Business Process Improvement for large Pharma and business clients including J&J, Bristol Myers Squibb, Ikaria, Eagle Environmental, and more.
• Experienced in full Software Development Lifecycle (SDLC) project development, Content Management, Process and Data Flow Diagramming including ‘As Is’ and ‘To Be’ scenarios, requirements gathering, GAP analysis & methodology development. Hands on in creating and leading multiple SOP and M&P Development projects.

Confidential, Plainsboro, NJ

Business Edge

Senior Business Analyst/Process Solutions

• Developed company Marketing Promotion Compliance and Labeling ‘Standards of Review’ and General Operating Procedures to support FDA Regulatory Compliance and CFR 21 Regulations and FDA DDMAC compliance for company product brands.
• Defined a ‘To - Be’ workflow process for the controlled review and approval of drug brand promotional materials involving Medical, Marketing, Legal, and Regulatory departments.
• Assisted in policy and directive development for the improvement of agency and joint Pharma venture partner integrations with Sanofi-Aventis.

Confidential, Titusville, NJ

Alliance Consulting

Senior Business Analyst/Pharma Solutions

• Documented processes and mapped data flow diagrams and transition plans for the merging of company business groups and Marketing Sales Organizations and SAP system.
• Evaluated company business processes across sales organization prioritizing issues and recommendations for the merging of Janssen Ortho-McNeil marketing business groups.
• Analyzed company Call Plan for Marketing Analytics and data analytics instituting a methodology for Call Plan Harmonization between Janssen and Ortho-McNeil sales force.

Confidential, Clinton, NJ

Senior Business Analyst / Process Engineering Consultant

• For innovative Biotherapeutic Pharma company, developed new business model and processes for building in-house business operations incorporating new business model processes, customer service Standard Operating Procedures, clinical trial data, and marketing/sales organization methodologies.
• Worked with CFO, VP, Directors, and management with Quality Assurance developing Standard Operating Procedures (SOPs) clinical procedures including process validation, Quality Assurance, CFR Part II and GxP compliance. Performed data modeling/design, wrote SOPs and content.
• Consulted and assisted with FDA content development and compliance regarding pharmacovigilance adverse events and clinical medical claims and content.

Confidential Edison, NJ

Knowledge Engineer/ Senior Team Lead

• As Content Project Lead for Artificial Intelligence (AI) Expert System Company assisted in securing client million dollar web projects for Call Centers, CRM, telecom clients AT&T, Nokia, Bell Atlantic Mobile, and US West. Knowledge Engineering Analyst for GAP analysis, business process development for large domestic and international Call Center implementations, e.g. AT&T, Philips, Ltd, etc.
• Led team of analysts and developers in the custom design, writing, validation, and implementation of large-scale Content and Document conversions for large corporate Call Centers, for AT&T Consumer Products, Bell Atlantic, Verizon Wireless. Legacy content conversions to corporate web-based VPN, Mobile and web applications. Performed Knowledge engineering, project scoping and content development projects.
• Acted as company liaison representative to European Call Center clients at Siemens, and Philips Ltd in the Netherlands and Germany for company knowledge-based product QSupport Pro and IQWeb for Verizon Wireless).