Lyle D. G. Email & Phone Number

Nation-Wide

Working to establish the groundwork forf a nation-wide network of trained Native American fire-fighters and disaster relief personnel.

Cut Bank, Montana

Technical editing of a small-sized book about being an umpire. Also providing document design services.

Billings, Montana

Manage Documentation Change Control System to support critical efforts for document life-cycle maintenance including authoring, editing, approving, releasing, publishing, distributing, and archiving Trained to FDA Good Manufacturing Practices and 21 CFR Part 111Technical writing and composition of document control procedures, corporate manuals, and documentsEstablish and coordinate training of employees on GMP/GLP functionsCertified internal auditor (basic and ISO 9001)FDA… Show more Manage Documentation Change Control System to support critical efforts for document life-cycle maintenance including authoring, editing, approving, releasing, publishing, distributing, and archiving Trained to FDA Good Manufacturing Practices and 21 CFR Part 111Technical writing and composition of document control procedures, corporate manuals, and documentsEstablish and coordinate training of employees on GMP/GLP functionsCertified internal auditor (basic and ISO 9001)FDA Inspection CoordinatorCoordinate and conduct internal audits for adherence to 21 CFR Part 111Write and train staff on AAP and FDA required procedures (inspections, vendor qualification program, adverse events, customer complaints)Wrote a Q&A based dietary supplement labeling guide based on 21 CFR Part 101.36Create, review, and/or approve all domestic and international corporate communications.Set corporate communications standardsKosher program monitoring and inspection coordinatorCreate and coordinate documentation requirements for FDA and international government filings (Europe, UAE, Canada, China, et. al) with AAP management and domestic and International sales staffCoordinated NSF Audit CertificationCoordinated CNCA (People's Republic of China) and FDA applications for a new Infant Milk FormulaWorking on implementing ISO 9001Friendly and considerate communication style when interacting with staff members“Go-To” person for creative solutions/problem-solvingWilling to take on challenges and special projectsUpfront with my commitment to projectsAvailability for 11th hour projects Show less

Santa Fe, New Mexico

Assisted music with music production business. Designed CD covers. Created mailing lists. Created promotional materials.

Three-month contract position to create technical documentation to support the State of New Mexico Division of Information Technology’s eMedicaid system. Restructured three manuals using established formats, editing to conform to professional IT writing standards, and designed Read Me file format. Composed two manuals (Employee Training using MS SharePoint and Trading Partner Management System). Coordinated writing requirements with other staff members. Conducted internet research to support… Show more Three-month contract position to create technical documentation to support the State of New Mexico Division of Information Technology’s eMedicaid system. Restructured three manuals using established formats, editing to conform to professional IT writing standards, and designed Read Me file format. Composed two manuals (Employee Training using MS SharePoint and Trading Partner Management System). Coordinated writing requirements with other staff members. Conducted internet research to support content of manuals. Show less

With general guidance from the Director of QA, worked independently with setting up a QA document control function. Wrote/revised core documentation SOPs, set up and issued documents to controlled binders, set up templates and trained staff on use, established distribution process, issued DCR numbers, tracked documents routing for signature, set up Excel spreadsheets for document number assignments, designed SOP templates, form templates, report templates, and improved or established many other… Show more With general guidance from the Director of QA, worked independently with setting up a QA document control function. Wrote/revised core documentation SOPs, set up and issued documents to controlled binders, set up templates and trained staff on use, established distribution process, issued DCR numbers, tracked documents routing for signature, set up Excel spreadsheets for document number assignments, designed SOP templates, form templates, report templates, and improved or established many other basic document control functions. Set up file room and filing system for documents (SOPs, Forms, Reports, Batch Records, Preclinical Reports, Stability Reports, et al.) and used Excel spreadsheets for tracking. Reported progress and/or problems to Director for discussion and resolution. Provided MS Word, Adobe Acrobat, and PowerPoint expertise to other users throughout the company (resident expert). Assisted with the coordination and production of documentation for an IND filing. Worked with a cross-section of XenoPort staff to meet documentation goals. Show less

Provided documentation support and problem-solving for Regulatory and Clinical departments on software applications used in department documents (MS Word, PDF, graphics, scanning, PowerPoint, and Visio). Assisted in development of templates for clinical study reports, clinical protocols, IND annual reports, clinical forms, investigator’s brochures, audit forms, and other templates as needed. Wrote abbreviated style guide based on the American Medication Association (AMA) Style Guide, 9th… Show more Provided documentation support and problem-solving for Regulatory and Clinical departments on software applications used in department documents (MS Word, PDF, graphics, scanning, PowerPoint, and Visio). Assisted in development of templates for clinical study reports, clinical protocols, IND annual reports, clinical forms, investigator’s brochures, audit forms, and other templates as needed. Wrote abbreviated style guide based on the American Medication Association (AMA) Style Guide, 9th Edition used as a resource for medical writing and other technical publishing guidelines (scanning, pdf creation, technical editing, using software programs, word processing, FDA links, and more).Established procedures for color and B&W scanning based on FDA guidelines for submissions. Created a customized Adobe Distiller script for creating PDF files compliant with guidelines for FDA submissions. Created a FileMaker database for the Regulatory staff to provide a submissions trail for FDA submissions and trained staff on its use. Worked with a vendor for implementing a documentation control system for evaluation and testing. Worked on Clinical Study Report template based on ICH E3 Guidelines. Assisted Regulatory Associates with FDA submissions. Show less

Technical writing of core document control procedures (Standard Operating Procedures, Change Control, Generation of Specifications, and other procedures). Developed templates for SOPs, Forms, Specifications, Master Batch Records, and other documents. Conducted employee group training for using templates and advanced Word 2000 capabilities. Developed instructional-use reference files (QA dictionary, “Read Me” files for using templates) for employees.

Technical editing and processing of controlled documents. Worked with authors to ensure timelines. Developed, redesigned, and maintained templates for controlled documents which were implemented company-wide. Established and implemented procedures for document processing. Issued batch records. Distributed indexes and controlled documents to binder stations, and coordinated audits of manuals and files. Provided electronic system administration for controlled documents. Assisted with the… Show more Technical editing and processing of controlled documents. Worked with authors to ensure timelines. Developed, redesigned, and maintained templates for controlled documents which were implemented company-wide. Established and implemented procedures for document processing. Issued batch records. Distributed indexes and controlled documents to binder stations, and coordinated audits of manuals and files. Provided electronic system administration for controlled documents. Assisted with the development, use, and maintenance of Excel and FileMaker databases. Hired, trained, and supervised other Document Control employees. Participated in and contributed to planning activities for an FDA review. Show less

Technical publishing for company BLA filing. Assistant document control department with processing documents.

In Regulatory Affairs, technical editing/word processing of clinical documents and FDA submissions. Edited documents to ensure consistency in grammar, style, and terminology. Provided advanced document creation for special projects. Extensive text and graphics conversions.In QA Document Control, created and edited controlled documents using QA standards, adhering to established guidelines and styles. Provided lead support in document creation and editing. Creation and testing of Word 6… Show more In Regulatory Affairs, technical editing/word processing of clinical documents and FDA submissions. Edited documents to ensure consistency in grammar, style, and terminology. Provided advanced document creation for special projects. Extensive text and graphics conversions.In QA Document Control, created and edited controlled documents using QA standards, adhering to established guidelines and styles. Provided lead support in document creation and editing. Creation and testing of Word 6 templates for an extensive document conversion. Contributed to content and format of QA and Technical Publishing Style Guides. Trained staff members on creation of controlled documents. Configured Apple Workgroup server. Systems Administrator (Xerox workstations and server maintenance and backup program).Acknowledgment in Clinical Immunology and Immunopathy, Vol. 74, No. 2, p. 191, Feb. 1995 for manuscript preparation of research article (Bispecific HER2xCD antibodies) authored by Dr. R. Shalaby, et al. Show less

Supported senior executives in Finance and Software divisions at Versatec and XSoft, Santa Clara and Palo Alto, CA.

Business Administration

High School Curriculum