Dana Arbuckle, NCCP

North Port, FL ***** ǀ 336-***-**** ǀ adz6r2@r.postjobfree.com

CAREER SUMMARY

Seasoned Certified Paralegal and Regulatory Submission Manager with over twenty years of product liability litigation and regulatory compliance experience managing medical records collection, attorney representation letters, client intake and inquiries, calendaring appointments, legal and regulatory research, and drafting legal and regulatory documents. Passionate writer and editor with a proven ability to create and edit legal, regulatory, and scientific documentation oriented towards delivering high quality work product to key stakeholders. Strong communicator with project management and organizational skills.

CAREER PROGRESSION

TAP ǀ Sarasota, FL 2022 - 2023

Paralegal

Conducted investigative legal research using Westlaw and PACER, and drafted/edited pleadings/contracts for personal injury cases 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 signatures via Adobe Sign for letters of representation.

RAI Services Company (subsidiary of British American Tobacco) ǀ Winston-Salem, NC 2020 - 2022

Senior Scientist

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. Managed signatures utilizing DocuSign.

Key Accomplishments:

● Identified and summarized significant FDA responses to competitor’s cleared product submission relating to nicotine dissolution for incorporation into future submissions to proactively mitigate deficiency responses.

● Successfully authored 9 SEs, 15 EAs, and 1 EXR utilizing TEAMS and Outlook to collaborate with internal and external stakeholders including Price Waterhouse Coopers (PwC) for submission to FDA.

ITG Brands, LLC (f/k/a Lorillard Tobacco Company, acquired in 2015) ǀ Greensboro, NC 2010 – 2020

Regulatory Analyst II 2016 - 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 FDAs various Requests for Information (“RFI”) and provided direct support in the assembly and upload of regulatory submissions. Initial Legal reviewer of documents produced to FDA during mandatory unannounced FDA site inspections for five (5) facilities.

Key Accomplishments:

● 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 participated in SCRUM.

Paralegal and Document Control Specialist 2015 - 2016

Subject matter expert (SME) for Serengeti, an electronic e-billing/matter management system, responsible for customizing legal matters and reviewing/approving invoices. Utilized Word to create SOPs and managed document maintenance and facilitated retention procedure.

Key Accomplishments:

● As part of the ITGB/RJR integration Team, successfully 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.

Dana Arbuckle, NCCP

Document Analyst 2010 - 2015

Managed the organization and collection of physical records and electronically stored information (ESI) for pending smoking and health litigation from 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. Collaborated with auditor from PwC in relation to tax documents.

Key Accomplishments:

● Successfully delivered 500+/weekly subjectively coded documents based on 18 categories comprised 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 and record retention process during mandatory unannounced FDA inspections for Lorillard’s three (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.

Womble, Carlyle, Sandridge & Rice, PLLC ǀ Winston-Salem, NC 2000 – 2010

Case Coordinator 2006 - 2010

Promoted in 12 months to write case summaries tracking litigation history for 100,000+ pharmaceutical and tobacco cases. Calendared deadlines in docket in case management system. Liaison for local and national counsels’ case history inquiries and litigation research. As Senior Paralegal, supervised teams of 10+ paralegals by conducting audits of work product for quality control of pleadings summaries with an emphasis on accuracy and data consistency. Leveraged SharePoint to provided monthly reports to local and national counsel.

Key Accomplishments:

● Completed in-house trial preparation training that included mock trial experience and Relativity demonstrations.

● Successfully conceptualized, developed, and presented database training (5 classes) to new employees to educate colleagues on data entry process and procedures.

Paralegal 2005 - 2006

Team lead for the Pharmaceutical Case Intake Team, responsible for achieving 100% success rate in authoring FDA Adverse Event (AE) reports by reviewing Complaints within the mandatory 24-hour deadline. Expected AE response rate of average 32/day. Successfully delivered 500+/weekly objectively coded documents for over 25,000 complaints.

Key Accomplishments:

● Exceeded daily AE response rate by average 7/day.

● Successfully conceptualized, developed, and presented training (8 classes) to new employees to educate colleagues on AE reporting and document coding.

Medical Records Specialist 2000 - 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.

Key Accomplishments:

● 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.

● Authored copy for company promotional brochures to promote ancillary services for distribution at trade shows.

EDUCATION ǀ 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

Notary Public Certificate – Expires 09/19/2026 State of Florida

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