Medical Product Development
Resume:
TEGRA A. ROSERA
Medical Writer/Editor
WORK HISTORY
The Document Medic (Sole Proprietorship)
Freelance Medical Writer/Editor 12/2009 – present (part-time from 3/2011 to present)
Prepared manuscripts for submission to journals. Duties included summarizing information from relevant source documents (clinical study reports [CSRs], pharmacokinetic reports, and investigator brochures) and organizing and formatting content according to the style of the journal.
Assisted researchers in developing and designing meta-analyses. Duties included writing meta-analysis protocols, researching appropriate statistical methods and consulting with statisticians to determine the appropriate statistical methods, coding data from the articles, and assisting researchers in writing select sections of the manuscripts.
Wrote blogs and white papers on regulatory subjects. Topics have included the approval process for medical devices, successfully submitting an application via the 505(b)2 mechanism, dealing with warning letters, the unique device identifier system, developing standard operating procedures, three-dimensional printing and the Food and Drug Administration, ISO 9001, pharmacovigilance audits, and the regulatory process for small-molecule compounds.
Wrote home study Continuing Medical Education (CME) courses for healthcare professionals. Duties included obtaining the appropriate references, writing the content from scratch, organizing the content, and writing the tests and answer keys. Topics have included tuberculosis, acute respiratory distress syndrome, and the role of digital radiography in the diagnosis and treatment of pneumoconiosis.
Edited medical advertisements, copy for websites, brochures, and brand books. Duties included fact checking the documents for accuracy; editing these documents for grammar, punctuation, spelling, and style (American Medical Association Manual of Style, 10th Edition, and client style guides); making certain that comments were appropriately incorporated during live rounds, comparing the wording of documents with that of previous versions, and checking the formatting of documents.
Wrote patient education materials. Specific duties included locating the appropriate references, writing the material based on an outline provided by the client, and making certain that the language was at a reading level appropriate for a general audience. Topics have included the digestive system, herpes labialis, depressive disorders, addiction, attention deficit-hyperactivity disorder, Alzheimer's disease, sleep disorders, autism, multiple sclerosis, traumatic brain injury, headaches, and cerebrovascular accidents.
Performed substantive editing of medical articles and college essays for authors who were not native speakers of English.
Researched meetings of various professional societies and maintained an Excel spreadsheet of these meetings.
Performed quality control (QC) reviews on protocols and CSRs.
Execupharm
Clinical Technical Editor (Contract) 6/2016 – 8/2017
Performed QC reviews of clinical study reports (CSRs), investigator brochures, and other regulatory documents. Duties included verifying the accuracy of the data and the references in these documents; editing them for grammar, punctuation, spelling, and style (American Medical Association Manual of Style, 10th Edition, and the sponsor’s style guide); formatting them according to the appropriate styles in the template, and verifying the accuracy of hyperlinks and bookmarks.
Assembled and performed QC on CSR appendices. Duties included compiling, formatting, and performing QC on the cover pages for Section 16.1 and 16.2; compiling and formatting documents for Section 16.1, 16.2, 16.3, and 16.4 (e.g., informed consent documents and case report forms [CRFs]); formatting tables, listings, and figures in Section 14 and Section 16.2; and comparing tables, listings, and figures listed on the cover pages of Sections 14.1, 14.2, and 14.3 with those listed in the sponsor’s database of source tables.
inVentiv Health
Medical Editor 2/2014– 3/2015
Performed QC reviews of CSRs, protocol amendments, regulatory responses, Module 2.7.1, Module 2.7.2, Module 2.7.4, and other regulatory documents. Duties included verifying the accuracy of the data and the references in these documents.
Performed QC reviews of journal articles, slide kits, meeting abstracts, and other commercial documents. Duties included verifying the accuracy of the data in these documents.
Performed editorial and formatting reviews of regulatory documents.
Performed editorial reviews of journal articles, slide kits, meeting abstracts, and other commercial documents. Duties included editing these documents for grammar, punctuation, spelling, and style (American Medical Association Manual of Style, 10th Edition and journal styles); verifying that the appropriate format for the journal, meeting, or slide kit template was followed; verifying references on PubMed and other sources and making certain that they were formatted according to the journal style; and making certain that the CONSORT guidelines were followed.
Checked galley proofs for accuracy with the submitted copy.
Premier Research
Technical Medical Writing Editor 2/2012– 1/2014
Updated clinical protocols for medical devices. Duties included rewriting and updating the introduction sections and adding new assessments, information, and justification for the studies per sponsor request.
Prepared electronic common technical documents and regulatory documents related to medical writing assignments when necessary.
Wrote serious adverse event (SAE) narratives from listings, pharmacovigilance narratives, and MedWATCH forms as appropriate.
Maintained document templates for protocols, CSRs, investigator brochures, statistical analysis plans (SAPs), and new drug applications. Developed new templates as needed.
Performed QC editorial, and formatting reviews on CSRs, clinical protocols, SAE narratives, investigator brochures, and other regulatory documents.
Assembled CSR appendices. Duties included compiling, formatting, and performing QC on the cover pages for Section 16.1; compiling and formatting documents for Section 16.1 (e.g., informed consent documents and case report forms [CRFs]); formatting tables, listings, and figures in Section 14 and Section 16.2; and comparing tables, listings, and figures with those listed at the end of the CSR and in the SAP.
Performed QC reviews on SAPs and associated documents. Duties included editing the SAPs and the listing shells for grammar, punctuation, and spelling; comparing the SAPs with the associated protocols to ensure that the information presented within them was accurate; editing listing shells for grammar, punctuation, and spelling and formatting them, comparing them with the CRF and the lists in the SAP, and numbering them according to the International Conference on Harmonisation guidelines; and performing blinded listing reviews after the data had been generated.
Celgene Corporation (Contractor through Aerotek Scientific)
Document Coordinator 3/2011– 1/2012
Performed QC and editing of clinical protocols, CSRs, investigator brochures, and other regulatory documents; Made certain that references in the text were in the reference list and in eSub, a Documentum-based system. Formatted regulatory documents in Word in accordance with Celgene templates and the style guide and made certain that the heading, text, and footnote styles were appropriately applied. Topics have included cancer and psoriasis.
Formatted pdf documents so that they complied with the Celgene style guide. Specific duties included creating bookmarks for various sections in the text, inserting hyperlinks to references within the text, making certain that the references to sections and studies in the text were in blue, fixing scanned pages that were skewed, and making certain that the document properties conformed to those in the Celgene style guide.
Compiled, formatted, and performed QC on appendices for FDA regulatory submissions.
Finalized bioanalytical reports and entered them into eSub. Specific duties included checking the documents for format and resolving any discrepancies, obtaining signatures from the appropriate personnel, and uploading the documents into eSub.
The University of Texas Health Sciences Campus/Center for Clinical and Translational Sciences
Scientific Editor 5/2009 - 10/2009
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 SAEs, provisions for monitoring clinical data, and content regarding Data Safety Monitoring Boards.
Performed substantive editing and reworking of manuscripts for submission to scientific journals.
Edited abstracts for submission to 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.
Worked with medical professionals under deadlines for submission of projects.
MannKind Corp (Contractor through Smith Hanley Consulting)
Contract Medical Editor 3/2008 - 2/2009
Wrote safety narratives and portions of the quality of life and safety sections for various CSRs.
Wrote errata for various clinical studies.
Performed QC and editing of protocols, CSRs, SAE narratives, investigator brochures, and 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. Formatted regulatory documents in accordance with ISI templates and made certain that styles were appropriately applied. Entered documents into Electronic Data Management System, a Documentum-based system.
Revised MannKind’s Regulatory Style Guide and developed the Editorial Working Guidance.
Developed training and instructional materials for newer editors and provided training in editorial and QC tasks.
Pharmaceutical Product Development, Inc (PPDI)
Document Review Specialist 10/2004 - 8/2007
Edited and performed QC on clinical protocols, CSRs and appendices, SAE narratives, and regulatory documents.
Projects included documents on conditions such as diabetes mellitus, AIDS, avian flu, migraines, and travelers’ diarrhea.
EDUCATION
Penn Foster College, PA
Currently enrolled in an Associate’s Degree program in Veterinary Technology, April 2016 to present
Drexel University, Philadelphia, PA
MS in Science Communications, June 2003
University of Southern California, Los Angeles, CA
MA in Occupational Therapy, May 2000
Agnes Scott College, Decatur, GA
Major: English Literature/Creative Writing. Minor: History. BA, May 1998
Raritan Valley Community College, NJ
Clinical research associate training
Drug Information Association
Regulatory writing course
National Institutes of Health
Grant writing workshops
InQuill Communications
Medical writing courses
Biostatistics and epidemiology courses
CME writing course (advanced)
American Medical Writers Association (AMWA)
Completed AMWA Core Certificate in Editing/Writing, 2006 Completed AMWA Core Certificate in Pharmaceuticals, 2007
Completed AMWA Advanced Certificate, 2013
AFFILIATIONS
AMWA
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