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Donna K. Campbell
312 S. Brooksville Ave.Brooksville, FL 34601
Home: 352-397-3557 Mobile: [email protected]
PROFESSIONAL EXPERIENCE
Bristol-Myers Squibb, Tampa, FL September 2016 – presentU.S. Labeling Specialist, R&D – North America Capability Center (NACC)
Independently identifies appropriate labeling information (e.g., medical content, pharmaceutical properties) from various source documents
Prepares required labeling documents (e.g., physician’s label, patient insert, carton, label, blister,) using text verification tools and label history logs to comply with electronic submission
Ensures all labeling supporting documentation and final approved label documents (internal and FDA approved) are logged in electronic management systems
Creates composition copy (single-dimension electronics file reflecting product information and graphics) and ensures that composition copy and final artwork comply with FDA regulations and BMS standards
Approves English version of composition copy and initiates final printed artwork for initial product launches and whenever changes to labeling information occur
Acts as subject matter expert advisor to Global regulatory for U.S. submissions Maintains up-to-date knowledge of regulatory labeling requirements of U.S. and communicates impact
on BMS business and products Prepares and delivers accurate, consistent, timely, and compliant labeling documents for submissions
to FDA Ensures timely and accurate implementation of product labeling for U.S. Determines the appropriate and optimum strategy for original and revisions of labeling text to ensure
FDA approval, including the best way to clearly and concisely present the labeling text in an unambiguous manner
Saint Leo University, Saint Leo, FL October 2015 – September 2016Quality Assurance Specialist/Copy Editor – Learning Design
Perform editorial duties related to all graduate and undergraduate online courses offered by the University, as well as the
support materials produced by Learning Design in conjunction with the developing faculty Review and edit educational content, passages, scenarios, and captions for grammar, punctuation, and
style from the development stage through the online design stage Ensure that all online courses adhere to the University style guide as well as MLA, APA, and ASA style
guides depending on the course subject matter (humanities, sociology, business, sciences, criminal justice, technology,
finance) Perform fact-checking and research as required Secure any needed copyright permissions for course materials Copy edit all supporting documents used in the courses: ADA materials, exams, rubrics, presentations,
videos scripts, slide decks, discussion questions, supplemental materials, directions/explanatory materials, syllabi Test that all links and embedded materials work correctly Provide style-correct citations and references
Bristol-Myers Squibb, Tampa, FL January 2014 – October 2015 Senior Proofreader – Content Development, Marketing Services – North America Capability Center (NACC)
Works as an extension of the brand review team and reviews and approves all promotional projects produced by BMS Studio
Edits all advertising, promotional, and educational projects to ensure: accuracy of spelling, grammar, punctuation, syntax, and
context, accuracy of references and other data, compliance with BMS corporate, FDA, and AMA guidelines, correct usage and
presentation of BMS trademarks, logos, and corporate branding, consistency and accuracy of layout components, overall sense,
continuity, consistency, clarity, and presentation Upon the client’s request, provides copyediting assistance to improve content and readability Proofreads all design and copywriting projects including hard copy documents, PDFs, PowerPoint
presentations (printed and on-screen), CD-ROMs, web pages, as well as various types of creative collateral Ensures all client and LMR annotations are made at specified junctures in the review process Ensures all deadlines are met Ensures Pharmaceutical Regulatory, Legal and, BMS Compliance guidelines are followed to the letter Ensures that branding guidelines are followed to the letter Interacts with the Account Executive to resolve issues, negotiate revisions, and verify information whenever
necessary Verifies correct version of Prescribing Information (PI), Brief Summary, Important Safety Information (ISI),
and Patient Information (PPI) Maintains, updates, and works from current master documents Provides final sign-off on projects at the disk release and blue-line stages to ensure accuracy Provides editorial contribution to and involvement in preparation and processing of materials for product
launches and POAs (Plan of Action meetings) Verifies references and ensures adherence to AMA guidelines
Saint Leo University, Saint Leo, FL October 2012 – January 2014Quality Control Coordinator/Proofreader/Copy Editor – Instructional Technology Department
Perform editorial duties related to online courses and support materials produced by Instructional Technology Department
Review and edit educational content, passages, scenarios, and captions for grammar, punctuation, and style from the
development stage through the online design stage Ensure that all online courses adhere to the University style guide Perform limited fact-checking and research, as required Secure any needed copyright permissions for course materials Proofread items and documents as required Enforce deadlines with diplomacy and tact Review courses after development to ensure quality standards are met Instruct faculty members on usage of online grammar- and plagiarism-checking tools available to faculty and
students
Universal Studios, Orlando, FL May 2012 – July 2012
Proofreader/QA Tester for website managed by IT: Contractor through AQUENT staffing, Orlando, FL
Proof screen text, verify all links and test website changes on main Universal Orlando website Set up procedure/scripts for testing website and merchandise/ticket/sales Be flexible to accommodate IT’s changing production schedule Perform side-by-side proofing and testing of revised site along side of production site Ensure correctness of all updates and functions Test functionality of completed website
UnitedHealthcare Medicare & Retirement (Medicare Solutions), Horsham, PA November 2009 – October 2011
Proofreader & Quality Analyst
Copy edit all pieces entering the versioning process for Agents, Business Development, and Retention Marketing, as well as reviewing new creative pieces
Act as member of Agents, Business Development, and Retention Marketing teams in review of initial creative pieces of their marketing initiatives, as well as versioning and refinement of campaigns in process, and signing off on all pieces from initial to vendor-proof stages
Attend all weekly status meetings for the Agents, Business Development, and Retention Marketing brand teams as an integral and valued team member
Assign work to junior analysts as needed Take full responsibility for the accuracy and proofing signoff of all Agents, Business Development, and Retention
Marketing tasks – whether through the online task assignment system or through offline e-mail/hand delivery Proof online almost exclusively, either in office or from remote location, using in-house task system in
conjunction with Adobe Acrobat Retain knowledge of specific brand and legal requirements and alert brand managers and project managers of any
discrepancies noted Review materials before going to print or Web portal Review all contents during material development process for spelling, grammar, punctuation, and consistency
within project deliverable and timeframes Work with project manager to help verify compliance with client and brand objectives, requirements, and
standards, including branding guidelines Review corrections to materials and monitor resolutions of all content issues to ensure accuracy Review heavy number comparisons on Excel spreadsheets Add metadata tags for tracking purposes to all pieces that are final proofed and approved
Group 360, St. Louis, MO – Telecommuting Position September 2008 – September 2009
Pharmaceutical Proofreader through Group360 agency for the Johnson & Johnson pharmaceutical companies:
Ortho-McNeil, Janssen, Centocor, Animas
AMA-style Proofreader Review, edit, and approve all assigned project deliverables against project documentation and specifications prior
to client delivery Proofread copy across all brands as a generalist, as well as handle copy for clinical trials and consumer campaigns Online editing/proofing using Adobe Acrobat for sales training modules and presentation pieces, internal and
external advertisements, product advertisements, slide decks, complex Web sites and visual aids Use online proofing software called Comparator for all jobs to be run against and any discrepancies resolved Manage time for projects through an online workflow Attend team meetings in New Jersey as needed Attend online and teleconferenced training and meetings as needed Knowledge of medical and pharmaceutical terminology
Institute for Corporate Productivity (i4cp), St. Petersburg, FL January 2008 – November 2008 The Institute for Corporate Productivity, formerly the Human Resource Institute, is a private membership network of major U. S. corporations with the focus on assisting their human resource departments in improving workforce productivity.Copy Editor/Proofreader
Work remotely to ensure accuracy of spelling, grammar, punctuation, syntax, and content of reports, surveys, white papers produced by a
Ensure compliance with nomenclature guidelines set forth by Managing Editor and Assistant Editor Ensure compliance with corporate nomenclature guidelines
Disney, Destinations Marketing – Yellow Shoes Creative Marketing June 2006 – December 2007
Copy Editor, Celebration, FL
Edit and proofread all advertising, promotional, and marketing collateral, including brochures, maps, guides, billboards, radio/TV/video scripts, as well as web and banner ads for Disney Parks and Resorts (Walt Disney World in Florida and Disneyland in California), Disney Cruise Line, Adventures by Disney Travel Company
Ensure accuracy of spelling, grammar, punctuation, syntax, and content Ensure compliance with legal guidelines as well as correct usage and presentation of all corporate and third-party
trademarks, logos, and branding Ensure compliance with corporate nomenclature guidelines Maintain and update corporate nomenclature files Contribute editorial expertise, ensure that all changes mandated by stakeholders have been implemented, verify all
art and layout format, and sign off at each stage up through blue-line/final proofs
Bristol-Myers Squibb, Plainsboro, NJ, February 2005 – June 2006
Pharmaceutical Copy Editor/Proofreader: Long-term contract through AQUENT staffing, Parsippany, NJ
Supervisor and Lead Creative Second-shift Non-product AMA-style Copy Editor/Proofreader Edit and proofread copy across all brands as a generalist, as well as handle copy for clinical trials and consumer
campaigns Online and hardcopy editing of sales training modules and presentation pieces, internal and external
advertisements, product advertisements, slide decks, and visual aids Hardcopy editing of Patient Information documents, web pages, and promotional premiums Frequent interaction with studio designers, account executives, traffic coordinators, regulatory, legal and medical
departments; as well as outside advertising agencies Extremely efficient in meeting and exceeding deadlines, especially during product launches and Plan of Action
(POA) campaigns when accommodation to scheduling necessitates extreme flexibility of days/hours
GCom2 Solutions, Aston, PA August 2004 – February 2005 Contract Proofreader through Creative Group staffing, Philadelphia, PA Provided Chicago-style of copyediting/proofreading services for a client who services national mutual fund
companies Proofed/reviewed prospectus reports, quarterly, semiannual, and annual financial statements Prepared Bluelines and Edgars to meet strict SEC regulated and client-mandated guidelines Also proofread color ads, brochures, and directories produced internally by their graphics designers
Merion Publications – Advance Newsmagazines (Healthcare) August 2001 – May 2004 Proofreader – Recruitment Ad Design Third-shift Proofreader for recruitment ads and product ads in 26 healthcare-related publications Responsibilities included content (grammar and spelling) as well as design layout Proofed text that was both recruitment and healthcare related
M. Campbell Associates, Finance Recruiters, Philadelphia, PA July 1997 – present Part-time Internet Researcher/ Database Coordinator Extensively research web for both potential client companies and potential candidates Set up and maintain web-based corporate database of clients and candidates Produce all corporate communications, both for the internet and hardcopy Produce all of the ad copy for positions in Treasury and Cash Management and put these out to both Big Boards &
niche sites
Education: BA in American Studies - Skidmore College, Saratoga Springs, NY