Peggy Gray Email & Phone Number

Newport Beach, Ca

Data entry of patient's medical reports for biopsies done every day. Setting up Headers for Pathology diagnosis; Assigning Pathologist to each case. Preparing nighly emails to Pathologists regarding next day's case readings. Prepared complex Excel spreadsheets, reports, and charts.

Irvine, Ca

Data entry of patient's medical reports for biopsies done every day for NewPath Labs. Setting up Headers for Pathology diagnosis; Assigning Pathologist to each case. Preparing nighly emails to Pathologists regarding next day's case readings. Prepared Excel reports and charts.

Experience Unlimited is supported by the EDD/One-Stop Center and is an all volunteer organization. Experience Unlimited provides skills enhancement, professional leadership skills, training, and on-going support.As a volunteer in the Operations Department, my managerial and administrative responsibilities include efficient and effective engagement with other Experience Unlimited members in a networking environment.

Provided complex, techical support and review of regulatory documents, Clinical Study Reports (CSRs), electronic Common Technical Documents (eCTDs), protocols, etc. Trusted partner with GSK in completed submission of New Drug Application (NDA) to the Food and Drug Administration (FDA) on epilepsy drug, one of the largest submissions ever received by the FDA. Compiled and published documents for large regulatory submissions, including CSRs and appendices, protocols and amendments, Investigator… Show more Provided complex, techical support and review of regulatory documents, Clinical Study Reports (CSRs), electronic Common Technical Documents (eCTDs), protocols, etc. Trusted partner with GSK in completed submission of New Drug Application (NDA) to the Food and Drug Administration (FDA) on epilepsy drug, one of the largest submissions ever received by the FDA. Compiled and published documents for large regulatory submissions, including CSRs and appendices, protocols and amendments, Investigator Brochures (IBs), etc. Quality checked documents, rendered to PDF, edited, bookmarked, and hyperlinked documents. Created bibliographic reference library of 3,500+ published references.• Instrumental in filing a 2.3 million page regulatory submission to FDA for epilepsy drug; application to FDA was so accurate, precise, and thorough it was approved for review within 2 months of submission.• Earned reputation as a trusted partner with GlaxoSmithKline as a result of completed submission of NDA to the FDA on epilepsy drug, submission of ISS document, and 120-Day Safety Report.• Compiled complex technical/regulatory documents (NDAs, INDs, CTDs, IBs, protocols, supplements, and amendments) for FDA approval using Microsoft Word and Excel, Adobe Acrobat Professional, and ISIToolBox, including extensive internal and external hyperlinks and bookmarks, quality checking and concatenation of all documents, QA'ing TLFs, and preparation of appendices for CSRs, IBs, protocols, and CTDs.• Hyperlinked, bookmarked (internal and external), and created Table of Contents for regulatory documents in accordance with regulatory publishing standards and guidelines.• Troubleshooting document issues, collaborating with scientific personnel in planning, preparation, publishing, and quality control of submissions. Show less

As a member of the Document Services Team for this management consulting organization specializing in human resources solutions, responsible for technical and production support on complex proposals, documents, presentations, letters, memos, and posters; experienced in analyst responsibilities performing client data preparation and reporting.• Created, edited, and finalized complex proposals, presentations, letters, memos, and emails, including proofreading for accuracy and camera-ready… Show more As a member of the Document Services Team for this management consulting organization specializing in human resources solutions, responsible for technical and production support on complex proposals, documents, presentations, letters, memos, and posters; experienced in analyst responsibilities performing client data preparation and reporting.• Created, edited, and finalized complex proposals, presentations, letters, memos, and emails, including proofreading for accuracy and camera-ready production. Managed document production process.• Provided administrative and financial support for clients and managed retiree medical payments monthly.• Depended upon as “go to person” for technical expertise, providing training seminars and one-on-one assistance to improve knowledge and productivity among the analysts and management team.• Provided feedback to clients on deliverables and recognized as valued “Trusted Partner.” Show less

In a fast paced, outsourcing desktop publishing / production design company, I supported our clients in publications, technical typesetting and design specializing in high volume, large documents including aerospace specifications / proposals, architectural / engineering specifications / documentation, college catalogs including their schedule of classes and associated art, medical journals / newsletters, automobile parts catalogs, and statistical books. Our client base included Boeing… Show more In a fast paced, outsourcing desktop publishing / production design company, I supported our clients in publications, technical typesetting and design specializing in high volume, large documents including aerospace specifications / proposals, architectural / engineering specifications / documentation, college catalogs including their schedule of classes and associated art, medical journals / newsletters, automobile parts catalogs, and statistical books. Our client base included Boeing, Northrup Grumman, Hughes, Raytheon, CH2M Hill, and Parsons.• Produced college course catalogs and associated schedule of classes, medical journals/newsletters, automobile parts catalogs, and statistical books per client specifications.• Used labs with various software versions to emulate client environment, including both Macs and PCs.• Using Macs and PCS, and various software to match the client's requirements, including, QuarkExpress, FrameMaker, and Adobe Acrobat. Show less