Dana Arbuckle
North Port,FL
Summary
Driven Certified Litigation Paralegal and Regulatory Submission Manager with 20+ years of mass tort litigation and regulatory compliance experience. Organized Project Manager with experience leading teams, facilitating meetings, overseeing workflow, drafting legal and regulatory documents, and conducting legal and regulatory research. Strong communicator with experience working with cross-functional partners and collaborating on shared project deadlines. Meticulous writer and editor with proven ability to create and edit legal, regulatory, and scientific documentation oriented towards delivering high quality work product to key stakeholders.
Overview
23
23
years of professional experience
Work History
Paralegal
The America Project
06.2022 - 06.2023
- Conducted investigative legal research using Westlaw and PACER, and drafted and edited contracts, NDAs, and pleadings to support legal strategies under the direction of the Chief Legal Officer
- Managed medical records collection, client and local counsel communications, and client intake
- Coordinated calendar scheduling and signatories via Adobe Sign for letters of representation/contracts
Senior Scientist - Regulatory Submissions
RAI Services Company (subsidiary of British American Tobacco)
06.2020 - 02.2022
- Submission manager and author of FDA Substantial Equivalent (SE) Reports along with Environmental Assessments (EA) and Exemption Requests (EXR) in alignment with British American Tobacco’s (BAT) product defense and competitive marketing strategies for American Snuff Company (ASC) and R.J Reynolds Vapor Company (RJRVC)
- Monitored competitive marketing orders and reviewed FDA’s Technical Project Lead (TPL) Reviews to provide recommendations for FOIA requests
- Reviewed FOIA documents and summarized significant FDA responses for tracking and utilization in subsequent Deficiency Responses
- Leveraged SharePoint and Appian for project management to organize documents and manage cross-functional workflow
- Identified and summarized significant FDA responses to competitor’s cleared product submissions relating to nicotine dissolution for incorporation into future submissions to pre-emptively mitigate deficiency responses
Regulatory Analyst II
ITG Brands, LLC
04.2016 - 05.2020
- Promoted in 9 months to lead cross-functional efforts to ensure that all mandatory State and Federal submission deadlines were met for a $3.5 billion portfolio for tobacco products
- Achieved 99.9% success rate for over 300+ mandatory regulatory State and Federal submissions
- As a member of ITGBs cigarette FDA Substantial Equivalent (SE) Response Team, provided significant support with regulatory writing, quality control, and Adobe editing emphasizing accuracy and data consistency
- Served as technical writer in response to FDA’s Requests for Information (RFI) and provided direct support in the assembly and upload of regulatory submissions through CTP portal
- Initial Legal reviewer of documents produced to FDA during mandatory unannounced FDA site inspections for five (5) facilities
- Led team of 8 to electronically search key data elements in over 15,000 pages within 2 days to defend a scientific position for an ingredient, mitigating regulatory risks for 20 key cigarette products
- Selected as initial Legal reviewer for the Legal Health Warning approval process for Tabacalera USA’s 1200+ premium cigar packaging redesign to ensure FDA compliance. Achieved 90% success rate through formal Legal approval by leveraging Excel
- Leveraged PowerPoint to successfully conceptualize, develop, and present regulatory training (12 classes) to key functional stakeholders to educate colleagues on FDA regulatory requirements and inspection processes
- Completed 8 hours of project management training from the Project Management Institute and actively participated in SCRUM
Paralegal and Document Control Specialist
ITG Brands, LLC
06.2015 - 04.2016
- Subject matter expert (SME) for Serengeti, an electronic e-billing/matter management system, responsible for customizing legal matters and reviewing/approving invoices
- Led and implemented a customized ITGB electronic Legal e-billing, matter management system for 100+ users including Regulatory, Legal, and external counsel
- Legal liaison to R.J Reynolds (RJR) for post-merger document requests
Document Analyst
ITG Brands, LLC
07.2010 - 06.2015
- Managed the organization and collection of physical records and electronically stored information (ESI) for pending smoking and health litigation from Lorillard Tobacco Company’s identified stakeholders
- Led document collection process and oversaw outside vendor (TCDi) in document productions
- Leveraged Visio to manage workflow for the Legal Department
- Drafted for Legal review responses to third-party subpoenas relating to employment, personal injury suits, and trademark/breach of contract litigation
- Successfully delivered 500+/weekly subjectively coded documents based on 18 categories composed of 66 requests and 14 key words with emphasis on smoking and health for over 20 million paper and electronic documents
- Successfully led document production/record retention process during mandatory unannounced FDA inspections for 3 facilities
- Initiated, developed, and implemented a standardized document production quality control checklist and procedure resulting in reduction of costly vendor errors by 8-10% in first year
Case Coordinator
Womble, Carlyle, Sandridge & Rice, PLLC
07.2006 - 07.2010
- Promoted in 12 months to write case summaries tracking litigation history for 100,000+ pharmaceutical and tobacco cases
- Utilized case management system to calendar deadlines in docket
- Liaison for local and national counsels’ case history inquiries and litigation research
- As Senior Paralegal, supervised teams of 10+ paralegals by reviewing pleadings summaries for quality control with an emphasis on accuracy and data consistency
- Leveraged SharePoint to provide monthly reports to local and national counsel
- Completed in-house trial preparation training that included mock trial experience and Relativity demonstration
- Successfully conceptualized, developed, and presented database training (5 classes) to employees to educate colleagues on data entry process and procedures
- Participated in volunteer program at Legal Aid of North Carolina to assist community in filing 50B or 50C protective orders
Paralegal
Womble, Carlyle, Sandridge & Rice, PLLC
07.2005 - 07.2006
- Team lead for the Pharmaceutical Case Intake Team, responsible for achieving 100% success rate in authoring FDA Adverse Event (AE) reports for Vioxx litigation by reviewing Complaints within the mandatory 24-hour deadline
- Expected AE response rate of average 32/day was exceeded by average 7/day
- Successfully conceptualized, developed, and presented training (8 classes) to new employees to educate colleagues on AE reporting and document coding
- Successfully delivered 500+/weekly objectively coded documents for over 25,000 complaints by average 7/day
Medical Records Specialist
Womble, Carlyle, Sandridge & Rice, PLLC
06.2000 - 06.2005
- Directed the collection and analysis of medical records and physical evidence in accordance with Health Insurance Portability and Accountability Act (HIPAA) regulations for 100,000+ tobacco cases
- Led team of 3 to search key data elements in over 500,000 pages to build tobacco litigation defense for RJR and Lorillard Tobacco Company
- Successfully conceptualized, developed, and presented training (5 classes) to new employees to educate colleagues on medical records and physical evidence collection processes
- Selected as initial Legal reviewer to work with RJR on multiple special document review projects and to write deposition summaries
Education
Bachelor of Arts - English & Psychology
St. Mary's College of Maryland
St. Mary's City, MDAssociate of Science - Paralegal Technology
Forsyth Technical Community College
Winston-salem, NCSkills
Organizational Efficiency
Project Management
Detail Oriented
Litigation Support
Case Management
Legal Research
Data Collection
Document Preparation
Records Management
Writing and Editing
Cross-Functional Communication
Proficient in MS Office
Education Certification
- Bachelor of Arts, English, St. Mary’s College of Maryland, St. Mary’s City, MD
- Bachelor of Arts, Psychology, St. Mary’s College of Maryland, St. Mary’s City, MD
- A.A.S., Paralegal Technology, Forsyth Technical Community College, Winston-Salem, NC
- Paralegal Certificate - Litigation, Forsyth Technical Community College, Winston-Salem, NC
- North Carolina Certified Paralegal (NCCP), North Carolina State Bar
- Notary Public Certificate, State of Florida, Expires 09/19/2026
- Project Management Course (8 hours), Project Management Institute (PMI)
Timeline
Paralegal
The America Project
06.2022 - 06.2023
Senior Scientist - Regulatory Submissions
RAI Services Company (subsidiary of British American Tobacco)
06.2020 - 02.2022
Regulatory Analyst II
ITG Brands, LLC
04.2016 - 05.2020
Paralegal and Document Control Specialist
ITG Brands, LLC
06.2015 - 04.2016
Document Analyst
ITG Brands, LLC
07.2010 - 06.2015
Case Coordinator
Womble, Carlyle, Sandridge & Rice, PLLC
07.2006 - 07.2010
Paralegal
Womble, Carlyle, Sandridge & Rice, PLLC
07.2005 - 07.2006
Medical Records Specialist
Womble, Carlyle, Sandridge & Rice, PLLC
06.2000 - 06.2005
Bachelor of Arts - English & Psychology
St. Mary's College of Maryland
Associate of Science - Paralegal Technology
Forsyth Technical Community College