Richard E. Ware, Ms, Mba work email
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Experienced Business Analyst providing business consulting services through Ware Consulting LLC. I've worked in the Pharmaceutical Drug Development area focusing on computer systems delivery for Clinical and Regulatory affairs. Areas of expertise include: Regulatory and Clinical document management, Regulatory publishing, and data/document migration between business entities.
Ware Consulting Llc
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Business Consultant, OwnerWare Consulting Llc Dec 2016 - PresentGarnet Valley, Pa
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Sr. Principal Business ConsultantAstrazeneca 2006 - 2016- Provided requirements analysis for global Regulatory document repository and submission publishing systems.- Implemented global Health Authority electronic submission gateways (FDA and EMA) for Regulatory Affairs Submission Management Group.- Consulted with the Global Regulatory Affairs professionals to develop new and re-engineered business processes to improve performance, meet new requirements and achieve strategic results.- Provided technical and systems analysis input to Regulatory Affairs continuous imporovements process to identify and propose improved technology- based solutions to optimize the performance, capability and efficiency of business processes.- Developed and managed IS plans and budgets for Regulatory Affairs system development. -
Systems ArchitectAstrazeneca 2004 - 2006- Lead AstraZeneca’s participation in Signatures and Authentication For Everyone (SAFE), a cross industry association to develop and maintain standards for identity authentication and digital signatures. Developed business justification for AZ participation as a founding member. - Lead the cross functional governance team responsible for directing activities related to SAFE technology. - Represent AZ on key SAFE working groups (executive, technical, implementation).- Provided architectural and business impact assessment of Structured Product Label (SPL) to GEL/RA architect and portfolio director as a part of the FDA's implementation team. - Represented AZ on the HL7 SPL Working Group and presented implementation details of SPL at DIA conferences. - Worked with AZ labeling staff to understand implementation issues and bring them to the attention of the SPL Working Group. - Worked as a member of the GEL SPL team to ensure that an SPL authoring capability was in place to meet FDA timelines. -
Director - Regulatory Affairs SystemsAstrazeneca 2000 - 2004Resposible for providing information systems support and skills to Regulatory Affairs department within the US business. Managed a group of twenty IS professionals and two managers. Worked closely with Regulatory Affairs leadership to ensure that IS plans are coordinated with business plans and to ensure that sufficient IS resources are in place to support submission plans. Responsible for identifying opportunities to implement information technology that will improve RA quality and efficiency. Member of the Development IS Reg. Affairs portfolio team to ensure resources are available as required to staff global Development IS projects and to ensure that projects required by the USRA organization are prioritized.In this position I also represent AstraZeneca on the Electronic Regulatory Submissions Working Group of the Pharmaceuticals Research and Manufacturer’s of America (PhRMA) and coordinate this work with other AZ IS representation at the European Federation of Pharmaceutical Industries and Associations (EFPIA).
Richard E. Ware, Ms, Mba Skills
Richard E. Ware, Ms, Mba Education Details
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Business Administration And Management, General -
Computer Science -
Management Information Systems, General
Frequently Asked Questions about Richard E. Ware, Ms, Mba
What company does Richard E. Ware, Ms, Mba work for?
Richard E. Ware, Ms, Mba works for Ware Consulting Llc
What is Richard E. Ware, Ms, Mba's role at the current company?
Richard E. Ware, Ms, Mba's current role is Business Analyst | System ArchitectConsultant specializing in Pharma Drug Development/Discovery business systems.
What is Richard E. Ware, Ms, Mba's email address?
Richard E. Ware, Ms, Mba's email address is ri****@****eca.com
What is Richard E. Ware, Ms, Mba's direct phone number?
Richard E. Ware, Ms, Mba's direct phone number is +120235*****
What schools did Richard E. Ware, Ms, Mba attend?
Richard E. Ware, Ms, Mba attended Widener University, Saint Joseph's University, Widener University.
What are some of Richard E. Ware, Ms, Mba's interests?
Richard E. Ware, Ms, Mba has interest in Science And Technology.
What skills is Richard E. Ware, Ms, Mba known for?
Richard E. Ware, Ms, Mba has skills like Pharmaceutical Industry, Business Analysis, Data Migration, 21 Cfr Part 11, Computer System Validation, Cross Functional Team Leadership, It Strategy, Sdlc, Change Management, Vendor Management, Project Portfolio Management, Validation.
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