Emily A. Email & Phone Number

Pflugerville, Tx, Us

Performs detailed QC review of complex clinical and regulatory documents, tables, publications, annual reports, literature summaries, submission sections, internal documents, etc. Verifies content to ensure accuracy of all factual statements within document text compared to post-text sources cited and interprets clinical data as needed to perform QC duties. Copyedits documents to correct and streamline grammar, spelling, punctuation, style, and format, while troubleshooting functionality and presentation of documents and templates. Prioritizes tasks, works simultaneously on multiple projects, and produces high-quality documents while adhering to tight timelines and shifting priorities and demands. Leads resolution of discrepant findings within documents, including documenting actions, verifying implementation of findings, and archiving results. Represents the QC group on study teams and on cross-functional project teams as needed. Identifies training needs and assists in the conduct of the training and development efforts of new and current global team members. Trains new hires and junior colleagues within the QC group and functions as a mentor. Provides QC training to members of the global Medical Writing team in aspects relative to their roles. Assists Medical Writing and QC management during the sales process by providing client support and proposals input. Serves as the project lead for deliverables of complex and/or large medical writing/QC projects, such as scheduling and leading internal project-specific team meetings, organizing project-specific requirements, and ensuring that all information is distributed to the QC team members and implemented as required. Leads standalone QC projects focused on process development, improvement, and implementation.

Remote

Performed detailed QC review of clinical documents, regulatory briefings, tables, safety summaries, publications, submission modules, and internal reports. Interpreted clinical data and literature as needed to perform QC duties. Proofread documents to correct and streamline grammar, spelling, style, and format. Verified that document content is consistent with internal, client, and health authority guidelines. Formatted, styled, and troubleshot functionality and presentation of documents and templates in Microsoft Word using Omnicia and PerfectIt toolbars. Assisted with literature searches, reference management, and bibliographies. Supported the validation of new software and alterations to existing software, such as Veeva Vault RIM and SharePoint. Updated and maintained the QC team's internal style guide.

Austin, Texas Area

Oversaw and maintained the archiving of all raw data, correspondence files, reports, equipment maintenance/repair/calibration records, and other archived materials for the analytical laboratory, as well as the archiving of all clinical and subject data, such as regulatory study binders, subject folders, and disqualification folders. Functioned as the liaison between Worldwide and the off-site archive facility. Interacted with clients and conducted tours of the on-site archive facilities. Employed TrackWise as a central system for tracking all archived studies. Maintained documentation for efficient retrieval of any material from archives and a current inventory list of clinical studies on site. In addition to archivist duties, initiated new, revised current, and obsoleted analytical test methods and common forms. Ensured analytical test methods and common forms were written in accordance with applicable SOPs, GLPs, and client requests. Set up and managed projects in TrackWise and Watson LIMS for the initiation of test methods. Communicated effectively internally with all levels of personnel and assisted the Document Coordinators with report compilations, reissues, and generation and revision of SOPs.

Remote

Proofread documents for spelling/grammar, formatting, and consistency to help facilitate the successful production and completion of deliverables in a professional and polished manner. Conducted literature and reference research activities to support medical writers and regulatory professionals. Performed QC verification for various regulatory and clinical research documents (including protocols, CSRs, statistical and pharmacological analysis plans, IBs, IND submissions, and other regulatory response components). Prepared appendices for CSRs in accordance with applicable national and international guidelines. Verified internal documents and appendices met publishing standards for submissions. Maintained and updated macro-enabled SOP templates for medical writing deliverables while verifying compliance with the following guidances: ICH, FDA, European Medicines Agency, AMA Manual of Style, and CORE reference. Provided trainings and one-on-one assistance for several internal departments regarding macro-enabled templates, formatting, Microsoft Word, and various other queries. Trained and mentored junior editors and other personnel in the Medical Writing department.

Austin, Texas

Initiated new and revised current technical documents written by scientists. Revised SOPs for formatting, grammar, consistency, and updated policies. Edited and formatted nonclinical reports for grammar and spelling errors and verified documents were submission ready prior to delivery to the FDA. Ensured documents were written in accordance with applicable SOPs, GLP/GCP guidelines, American Chemical Society style guide, and client requests. Maintained a record of multiple deliverables in various stages of completion or review with several internal departments. Completed numerous first-to-file studies with expedited deadlines while collaborating with team members. Designed and implemented VBA macro-enabled templates to reduce errors and ensure consistency throughout documents. Provided classes and support for scientists regarding troubleshooting and formatting in Microsoft Word.

Colorado Springs, Colorado

Edited complex military software documents and technical engineering forms for grammar and formatting errors. Conducted author reviews with engineers to discuss illustrations, track changes, and questions/concerns. Assisted technical writers with editing and reviewing specifications and specification change notices. Established a training guide for new editors and worked with the editing team to develop a standard checklist for all editors to use. Developed a descriptive formatting guide based on knowledge collected from subject matter experts. Recorded minutes for several confidential government meetings. Identified a study with plagiarized material and designed curriculum to educate engineers about copyright infringement and proper citations. Employed various style guides, including The Chicago Manual of Style, United States Government Printing Office Style Manual, and Strunk and White’s Elements of Style.

Colorado Springs, Colorado Area

Assisted orthodontist and clinical staff with patient care and good health practices. Wrote and copyedited exposés for local children’s magazines while managing the advertising on a social networking site. Edited letters mailed to both patients and insurance companies. Handled patient interactions, financial information, new consultations, and Medicaid insurance questions. Proactively tracked Medicaid patient claims, appealed denials, and submitted requests for reimbursement.

Monument, Co

Assessed hundreds of students’ papers for English grammar and syntax. Taught 7th grade English grammar, research, and writing classes while working with a team of teachers and a variety of students, including both special education and gifted students. Assisted in developing community service projects for students to participate in. Wrote behavioral contracts, detailing student conduct and developing skills, for parent-teacher conferences. Collaborated with teams to focus on interventions for at-risk students to help improve their reading and writing skills.

Webb City, Mo

Edited and graded student’s papers based on a strict set of guidelines from the Missouri Department of Education, which included grammar, spelling, punctuation, and formal usage/phrasing. Taught 9th and 10th grade grammar and literature while working with a team of teachers to document strategies/modifications for students who struggled in reading, writing, and research. Collaborated with co-workers to develop a study hall hour for students that focused on making up missed assignments and practicing grammar skills. Attended continuing education courses to gain knowledge about journalism, business, and technology skills. Successfully directed a Publications class and produced a yearbook as the high school's yearbook advisor.