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EXPERIENCE The University of Texas Health Sciences Campus (5/09 - 10/09): Worked as a scientific editor for the Center for Clinical and Translational Sciences in Houston, TX. • Performed substantive editing and reworking of manuscripts for submission to scientific journals. Duties included editing these manuscripts for grammar, punctuation, and spelling; removing and rewriting stilted and awkward phrases; reorganizing the manuscripts as necessary, and making certain that the manuscripts followed the style of the journal to which they were submitted. • Edited abstracts for submission to conferences. Duties included editing these abstracts for grammar, punctuation, and spelling; improving the readability and flow of the abstracts; and making certain that the abstracts conformed to word limits stipulated by the organizations conducting the conferences. • Edited grants for grammar, punctuation, and spelling. Formatted these documents to make certain that they conformed to the National Institutes of Health Guidelines or the guidelines of specific organizations to which the grant was submitted. • Provided guidance to investigators regarding the requirements for the contents of clinical protocols under 21 Code of Federal Regulations and International Conference on Harmonisaton: E6(R1). Specific suggestions included adding content regarding the reporting of serious adverse events (SAEs), provisions for monitoring clinical data, and content regarding Data Safety Monitoring Boards. • Worked collaboratively with medical professionals under deadlines for submission of projects. MannKind Corp (Contractor through Smith Hanley Consulting) (3/08 - 2/09): Worked as a contract medical editor in Paramus, NJ. Specific duties included performing editorial functions for regulatory documents related to MannKind’s New Drug Application (NDA) submission of inhaled insulin for the treatment of type 1 and type 2 diabetes mellitus. • Performed quality control (QC)/data verification on clinical protocols, clinical study reports (CSRs), SAE narratives, investigator brochures, and other regulatory documents and edited these documents for grammar, punctuation, and spelling in accordance with Mannkind’s style guide, Mannkind’s Editorial Working Guidance, and the American Medical Association Manual of Style, 10th Edition. • Formatted regulatory documents in accordance with ISI templates and made certain that various styles, such as heading, text, and footnote styles, were appropriately applied. Finalized documents by entering them into Electronic Data Management System (EDMS), a Documentum-based system. • Served in a key role of the revision of Mannkind’s Regulatory Style Guide and development of the Editorial Working Guidance. Developed training and instructional materials for newer editors and provided training in editorial and QC tasks. • Wrote safety narratives and portions of the quality of life and safety sections for various CSRs. Wrote errata for various clinical studies. Pharmaceutical Product Development, Inc [PPDI] (10/04 - 8/07): Worked as a document review specialist in Austin, TX, in the medical writing department of this global contract research organization (CRO), which provides discovery, development, and postapproval services, as well as compound partnering programs for pharmaceutical, biotechnology, medical device, academic, and government organizations. • Edited clinical protocols, CSRs and appendices, SAE narratives, and other regulatory documents for consistency in grammar, punctuation, and spelling. • Made certain that documents complied with regulatory guidelines and cross-checked regulatory documents with source documents for accuracy. Through this, discovered and corrected factual errors in documents before their submission. • Projects included, but were not limited to, conditions such as diabetes mellitus, AIDS, bird flu, migraines, and travelers’ diarrhea, requiring a great emphasis on detail. Spectrum Staffing and Lakeland Personnel (intermittent employment from 12/03 – 9/04): Worked in various temporary assignments for these New Jersey employment agencies. Assignments included preparing binders for LifeCell and working on the Time Magazine Archive Project at Hewlett-Packard. RSi Communications (6/02 - 12/02): Worked as an intern for six months in the editorial department at this medical communications and continuing medical education company in Hackensack, NJ. Duties included writing and editing biographies, proofreading abstracts, fact checking and entering references into a database in Endnote, performing internet-based research on medication treatments for pain, pulmonary hypertension, and diabetes mellitus, determining the appropriateness of articles for journals, and assisting in special assignments. Drexel University (9/01 - 6/02 and 1/03 - 6/03): Worked as a Research Assistant for the Communications Department. Duties included editing graduate students’ theses for format, editing professors’ papers, data entry using Microsoft Excel, researching topics through the Internet and in libraries for professors, and performing clerical work. OUR PLACE (9/00 - 3/01): At this psychosocial day treatment center for veterans with schizophrenia in Los Angeles, designed and carried out group treatment sessions. Specific groups included music interpretation and self-reflection. Taught social interaction skills through games and craft activities. Ashbrook Nursing & Rehabilitation Center, Greenbrook Manor, Cornell Nursing & Rehabilitation Center, and Clark Nursing and Rehabilitation Center (12/96 - 1/97 and 12/97): Worked as an Occupational Therapy Volunteer on the observational level and performed volunteer work in Recreational Therapy. ScienceTemps (intermittent employment from 1992 - 1997): At this scientific employment agency in Cranford, NJ, helped to prepare mailings at various times and worked on a temporary assignment for one week at Nabisco Foods on Fairlawn, NJ, in March 1997. Camp Merry Heart (summers of 1992, 1993, 1994, and 1995): Was employed as a Junior Counselor at this Easter Seal Camp for disabled children, adolescents, and adults in Hackettstown, NJ. EDUCATION Drexel University, Philadelphia, PA (2001 - 2003): MS in Science Communications, June 2003. University of Southern California, Los Angeles, CA (1998 - 2000): MA in Occupational Therapy, May 2000. Agnes Scott College, Decatur, GA (1994 - 1998): Major: English Literature/Creative Writing. Minor: History. BA, May 1998. PROFESSIONAL ORGANIZATIONS American Medical Writers Association (AMWA) 2006 – Completed AMWA Core Certificate in Editing/Writing 2007 – Completed AMWA Core Certificate in Pharmaceuticals Society for Technical Communication
$50 USD/hr
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