English, Professional Writing Certificate, University of North Carolina Wilmington (2006)

Associate, Biologics Consulting Group, Inc.
Alexandria, VA

• Experienced in publishing and submission of electric documents via the FDA Electronic Submissions Gateway
• Experienced in eCTD building/validation
• Familiar with FDA electronic submissions specifications
• Familiar with legacy IND format (following form 1571) and CTD format
• Expertise in publishing of clinical study reports
• Provides regular support to US Agent clients with regard to IND and BLA maintenance (amendments)
• Responsible for regular maintenance and updating of BCG web site (using Adobe Dreamweaver)

Electronic Publishing Specialist, Pharmaceutical Product Development Inc. (PPD, Inc.), Wilmington, NC.

• Provided clients with submission-ready, regulatory-compliant, deliverables in CTD/eCTD, eNDA, Loose Electronic and PDF Compilation formats
• Proficient in multiple versions of Adobe Acrobat and ISIToolbox, major tasks include but not limited to: Publishing CRFs, Bookmarking, Internal/External linking, Distilling, Margin-Adjusting, Page Cleaning, and several other duties
• Maintained a level of expert knowledge in publishing standards, and in ICH and FDA guidelines
• Worked closely and directly with Medical Writers, Regulatory Submissions, Biostatisticians, Data Management and internal and external clients
• Managed and tracking client deliverables in an internal archive

Editor’s Assistant, American Geophysical Union (AGU), Washington, DC

• Solicited/assigned editors, reviewers and associate editors to each manuscript for the peer-review process, quality control of incoming manuscripts, problem-solving, fact-checking
• Uploaded, prepared and formatted manuscript files (text, images and dynamic content) and content to our online tracking system, inputting critical data for each manuscript into our system using a variety of programs
• Problem-solving and working closely with: authors, editors, associate editors, copy editors, and reviewers in the geophysical community to ensure that the publication process is efficient and on schedule
• Member of AGU’s “Clear and Uniform Policy” Task Force

Proofreader, American Geophysical Union (AGU), Washington, DC.

• Proofreading responsibilities included: proofing and editing manuscripts and book chapters in PDF, HTML, LaTex and XML formats, and editing online journals using XML code
• Helped implement AGU’s “Legacy Project,” putting scientific journals, articles and books dating from 1919 to electronic and web format

Community Support Specialist, CNC/Access, Wilmington, NC.

• Duties included: providing support and helping adolescents and adults with mental disabilities function and maintain a normal lifestyle in the community and at home

The Seahawk Newspaper, Wilmington, NC

• Promoted from Staff Writer to Senior Staff Writer and from Senior Staff Writer to News Editor
• Duties included assigning, editing, writing and laying-out stories for the front page and news section

PUBLISHING / JOURNALISM-RELATED EXPERIENCE & AWARDS

• Earned the 2005-2006 Best Section Editor Award as News Editor for The Seahawk, the University of North Carolina Wilmington’s weekly newspaper
• 2004-2005 Outstanding Rookie Award for work at The Seahawk, from the University of North Carolina Wilmington, Student Media Board
• Experience using HTML, XML, Adobe Acrobat,  InDesign, Photoshop and PageMaker programs, ISIToolbox, Microsoft Word, Excel, PowerPoint, Publisher, FrontPage and Adobe DreamWeaver
• Completion of Certification in Professional Writing