Quality Assurance Medical
Resume:
David Bogdan
Email: *********@********.***
Address: 22010East Avenue
City: Rochester
State: NY
Zip: 14610
Country: USA
Phone: 585-***-****
Skill Level: Experienced
Salary Range: 85
Primary Skills/Experience:
See Resume
Educational Background:
See Resume
Job History / Details:
David Bogdan, MS
2201 East Avenue, Rochester, New York 14610 585-***-**** - *********@********.***
Finding Solutions for training, medical, technical, and creative writing
az Medical Communications Consultants (MCC) (Home-based) a" May 2012 to September 2012
Freelance Medical Writer
a Wrote/edited regulatory documents including Patient Narratives and a Clinical Study Report project
a Performed quality assurance and statistical data validations (SDV) on above documents
a Applied client style guide standards to documents and performed grammatical and punctuation checks
az i3Statprobe, (Home-based position) a" September 2009 to September 2011
Senior Medical and Technical Writer/Editor
a Wrote, edited, and published regulatory documents including Protocols, Investigational Plans, and Clinical Study Reports
a Performed quality assurance and SDVs
a Wrote patient narratives
a Facilitated meetings related to documentation review and approval
a Developed templates and style guides for the medical writing group
a Wrote/edited regulatory documents (SOPs, standards, charters, etc.) in support of a documentation
re-engineering project
az DB Productions, Rochester, New York a" May 2009 to September 2009
Freelance Medical Writer
a Wrote and edited medical protocols, final reports, and other medical communications materials
a Performed quality assurance and statistical data validation (SDV)
az Bausch and Lomb, Rochester, New York a" January 2004 to May 2006 (Full Time Consultant); June 2006 to May 2009 (Full Time Employee) Senior Medical Writer
a Wrote, edited, and published regulatory documents including Protocols, Investigational Plans, and Clinical Study Reports in the clinical research areas of vision care, pharmaceutical, surgical, and refractive
a Performed quality assurance SDVs
a Edited medical abstracts and journal reviews for non-English authors
a Developed and updated templates and processes, reference guides, Field Observation Studies, and other support documents
a Served as Editor-in-Chief for a quarterly newsletter
a Contributed to the development of submission documents including Annual Reports, INDs, NDAs and CIBs
a Developed templates and style guides for the medical writing group
a Facilitated meetings related to a documentation review and approval of documents
a Applied ICH E3 standards for documentation development for FDA submission
a Received training on eCTD format submissions
az PM&L, Inc., Rochester, New York
Medical and Technical Writer a" May 2005 to April 2006 (contract position)
a Authored book detailing a Grant Management System, a web-based application for the Leukemia and Lymphoma Society with historical references
a Developed and edited instructional materials and marketing documents
az Xerox Corporation, Rochester, New York
Documentation Specialist, Training Developer - March 2003 to November 2003 (contract position)
a Developed documentation and training materials for the Security Risk Management group
a Acted as editor for versioning control
a Developed internal training materials for security assurance
az NexPress Solutionsa"A Kodak Company, Rochester, New York
Training Developer, Technical Writer June 2001 to February 2003 (contract position)
a Wrote/edited user guides and training materials for a high-end digital color production press
a Developed internal and external marketing and training materials
a Wrote/edited material for Knowledge Management Systems
az Technical Learning Recourses, Inc., Rochester, New York/San Diego California
Training Developer - January 1998 to March 2002 (contract position)
a Wrote/edited training books (instructor/student) for a variety of clients, including Microsoft and Gateway
a Supervised the assembly of training materials for final publication
az Alstom Signaling, Inc., Rochester, New York
Documentation Specialist, Project Configuration Manager, Translator - August 1999 to July 2001 (contract position)
a Acted as Document Lead and Configuration Manager for a rapid transit system project
a Performed stand-up training for industry-related topics
a Acted as technical translator and editor for documents from French/English and English/French
az Xerox Corporation, Rochester, New York
Documentation Specialist - April 1998 to August 1999 (contract position)
a Acted as Documentation Team Lead for a large Services Management Systems group
a Wrote/edited technical and user documentation
a Conducted needs assessment and tracking systems for technical and user documentation
az West Publishing Group, Rochester, New York
Training Developer, Technical Writer, Documentation Specialist - September 1996 to July 1997
(contract position)
a Developed training materials in a legal publishing environment
a Wrote, edited, and validated user manuals, training materials, and software documentation
az Johnson & Johnson, Rochester, New York
Medical Writer - November 1995 to July 1996 (contract position)
a Wrote/edited training materials for Technical and Regulatory Affairs (T&RA) Department, including clinical protocols
a Benchmarked ISO9000 and Good Marketing Practices standards with T&RA programs
Technical Experience:
Operating Systems:
All Windows environments
Software:
Proficient in: Microsoft Office, Adobe products (Distiller, Acrobat, FrameMaker, PageMaker, InDesign) ABC Flowcharter, VisioPro, Documentum-based programs, Lotus Applications (Notes, WordPro, Freelance Graphics), WordPerfect, RequistePro, graphic design applications
Education:
Rochester Institute of Technology, Rochester, NY a" Master of Science, Instructional Design
St. John Fisher College, Rochester, NY - Bachelor of Arts, French and English (Minors in Education and Communications)
University of Grenoble (France) Certificat daEtude
AMWA Courses:
Biomedical Research Design - October 2008
Basics of Human Anatomy and Physiology a" October 2008
Basic Cell Biology - October 2008
Ocular Pathology - October 2008
Elements of Medical Terminology a" October 2007
Statistics for Medical Writers and Editors - October 2007
DIA Courses:
Writing a Final Report a" August 2007
Statistics for Medical Reports a" February 2008
Affiliations:
Drug Information Association (DIA)
American Medical Writers Association (AMWA)
George Eastman House and International Museum of Photography (Rochester, NY)
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