Experience

Daelight Solutions

• United States
• IT Services and IT Consulting
• 1 - 100 Employee

• Senior Consultant

  • Apr 2022 - Present

  Daelight Solutions is an IT consulting company that helps its clients navigate enterprise information challenges. Centered on delivering meaningful outcomes and value, Daelight has an expert team of life sciences IT specialists with more than a century of combined experience in the space, providing clients with services that ensure IT projects begin with the real world in mind. Daelight Solutions is an IT consulting company that helps its clients navigate enterprise information challenges. Centered on delivering meaningful outcomes and value, Daelight has an expert team of life sciences IT specialists with more than a century of combined experience in the space, providing clients with services that ensure IT projects begin with the real world in mind.



AbbVie

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Director, Business Information Management

  • May 2020 - Apr 2022

  Continued role as Controlled Document Management Service Owner responsible for end-to-end service delivery and management of multiple applications supporting the Regulatory and Clinical areas within Research and Development. Managed Veeva Vault domain level configuration settings applicable to all vaults in the domain as Veeva Vault Allergan Domain Administrator. • Performed Vault configuration changes (for example, adding document types and attributes) as Clinical Vault Owner and Administrator; uploaded/modified document attributes, users and other objects using Vault Loader and the bulk update feature; bulk exported documents, renditions, document versions and audit trails to address divestitures, Legal requests, and archives. Managed approximately 24K internal and external Clinical Study Site Personnel Clinical Vault user accounts. • Contributed to the AbbVie Clinical Integration program by participating, as a subject matter expert and content/configuration analyst, to the establishment of Study Start Up functionality in the AbbVie electronic Trial Master File (eTMF) Vault, the migration of content from the legacy Allergan Clinical Vault, the archiving of approximately 700K documents from the legacy Allergan Clinical Vault representing content not migrating to the corresponding AbbVie vault, and the eventual retirement and decommissioning of the Clinical Vault. • Participated in the Regulatory Integration program by providing subject matter expertise on the legacy Allergan ARCH application (OpenText D2 Life Sciences Research and Development) and supported the migration of ARCH content to the AbbVie COSMOS system. Performed data analysis using dqMan, DQL, and SQL Developer to facilitate the successful migration of documents to the AbbVie system, unifying business processes and, via legacy Allergan application decommissioning, reducing the application portfolio. Show less



Allergan

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Technology Delivery Services Manager

  • Mar 2007 - May 2020

  Supported multiple business functions, including Global Regulatory Affairs and Medical Writing, Drug Development Operations, Research and Development Document Management Community, Quality and Manufacturing Document Management users across Global Operations. • Oversaw Health Regulated Authority Controlled Document Management applications that securely stored approximately six million Research and Development documents, including Submission and Clinical Trial Master File Documents in support of over 6,000 Regulatory Applications and 9,000 submissions, include key New Drug Applications. The applications also managed approximately two million Quality and Manufacturing Documents, including Controlled SOPs, Procedures, Engineering Change Requests, and a variety of other GxP documents, in support of critical quality and manufacturing processes globally. • Supported approximately 3,500 Research and Development Document Management customers, approximately 6,500 Quality and Manufacturing customers, and oversaw the resolution of approximately 3,000 support tickets annually. • Facilitated the successful $4M Clinical Vault electronic Trial Master File (eTMF) and Study Start Up (SSU) implementations allowing the business to manage the complex, multi-step Study Start Up process in the Clinical Vault instead of Excel spreadsheets for new studies. • Represented Research and Development and the legacy source systems during the global One Vault (Veeva Qualitydocs) implementation consolidating six legacy applications and decommissioned the legacy applications that were replaced. • Supported the $58M, five-year Agility program, including external hosting, specifically the analysis, design, testing, training, implementation, and content migration to the ARCH application (OpenText D2 Life Sciences Research and Development), achieving a 25% improvement in post publishing process efficiency and enabling simultaneous regulatory submission capabilities. Show less



Triad Financial SM LLC

• Financial Services
• 100 - 200 Employee

• Senior Manager, Application Development

  • Oct 2003 - Mar 2007

  Developed and managed loan origination systems supporting both the Direct and Indirect lines of business. Worked with Senior VP to enhance and support the custom, in-house Direct Lending loan origination system and interfaces. Processed over 2.5 million Direct Lending loan applications annually. Led RoadLoans.com internet site redesign, through which loan applications are directly received. Implemented several strategic Direct Lending partnerships including ELOAN, Capital One, CarMax, and SAM’s Club that significantly increased loan applications and expanded the business. Delivered new indirect lending loan origination system with a configurable decision engine to enable more nimble responses to evolving business requirements and credit score card adjustments. Processed over 1.6 million Indirect Lending loan applications annually. Show less



Conagra Brands

• United States
• Food and Beverage Services
• 700 & Above Employee

• Program Manager

  • Aug 1997 - Oct 2003

  Responsible for the development and maintenance of information systems support the Sales and Marketing business communities. Responsible for the development and maintenance of information systems support the Sales and Marketing business communities.



CSC

• United States
• Information Technology & Services
• 700 & Above Employee

• Senior Computer Scientist

  • Jan 1995 - Aug 1997

  Internet/Web Program Manager for the Emerging Technologies group. (Outsourced from Hughes Aircraft Company). Developed new business proposals utilizing Web-based products and services. Internet/Web Program Manager for the Emerging Technologies group. (Outsourced from Hughes Aircraft Company). Developed new business proposals utilizing Web-based products and services.



Hughes Aircraft Company

• Aviation and Aerospace Component Manufacturing
• 100 - 200 Employee

• Senior Computer Scientist

  • Sep 1981 - Jan 1995

  Developed a high level Information Systems Management Architecture relating major common data initiatives including: Enterprise Architecture, Common Data Definitions, logical project models, the repository, data warehouses and warehouse development tools, and data access tools. Developed and managed business acquisition and pricing systems used to price multi-million dollar defense proposals. Developed a high level Information Systems Management Architecture relating major common data initiatives including: Enterprise Architecture, Common Data Definitions, logical project models, the repository, data warehouses and warehouse development tools, and data access tools. Developed and managed business acquisition and pricing systems used to price multi-million dollar defense proposals.