Carol G. Email & Phone Number

Internal Security Assessor for PCI-DSS (Payment Card Industry Data Security Standard).Requirements development for HPE NonStop security and compliance software. Defining GDPR (General Data Protection Regulation) and PCI-DSS requirements for compliance and security software. Managing business analysts and documentation team members.

Simi Valley

Regulatory Affairs Operations and CMC:I supported regulatory information management, business process improvements, global data standardization and data remediation efforts including executive leadership presentation support, meeting facilitation and coordinating international teams. Provided CMC support for workload planning, data cleansing and tracking the accuracy and completeness of information consumed by safety systems such as ARGUS.Global Development Organization:Implemented new business processes and governance in support of clinical trials registrations and results postings to Clinicaltrials.gov. After observing the numerous hours staff spent generating reports for upper management, I setup an on-demand reporting service that is a reproducible, reliable method for monitoring compliance and projected workload that removed manual report manipulation, reduced errors and decreased work effort from hours to seconds.Scientific Affairs:I supported the REMS (Risk Evaluation Mitigation Strategies) program by advising on REMS database updates and managing proposals for web-site changes required for submission to the FDA.Documentum and FirstDoc:As the Business Analyst for regulated document management, I liaised between functional areas and technical services to ensure business specific requirements were met. In collaboration with internal clients, I established a service to monitor the day-to-day functions and to pull in the appropriate technical partners to resolve issues or delays that were interfering with the delivery of regulatory submissions. I provided support for the trial master file (TMF) and inspection readiness efforts (MHRA, FDA) by generating reports to view the status of documents, the completeness of the TMF and to assist with TMF cleanup efforts.

I worked with the consulting services in the definition and delivery of customized solutions for drug discovery clients and I provided technical support for end users and for new sales opportunities.I proactively managed customer support for more than thirty customer accounts, including world wide support for three key accounts; Bristol Myers Squibb, J&J, and Sanofi-Aventis. I identified a new consulting opportunity, prototyped a solution and worked with developers through implementation. This project resulted in sales surpassing 223% of the target for the quarter.

In this role, I directed developers, IS staff, and technical support in development of a new line of gene expression software.I elicited customer requirements, consulted on project objectives and trained end users in how to analyze gene expression data.I was also responsible for the business plans and performed marketing and competitive product analysis on competing software including the review of published patents for prior art and related technology.

Working first in Technical Support and later in Product Management I developed customized demonstrations and training materials for technical sales presentations and end user training. My efforts to focus presentations on the issues faced by prospective clients resulted in $607,000 of new business in my 1st year.

B.S.

Doctor Of Philosophy (Ph.D.)