Tamara DuBois
Wilmington
Summary
Dynamic publishing professional with a proven history of managing workflows and delivering high-quality documents. Expertise in streamlining processes to ensure timely project delivery while effectively managing multiple priorities. Adaptability to evolving needs is complemented by a solid understanding of FDA requirements, enhancing the ability to meet industry standards and client expectations. Committed to driving efficiency and excellence in every project.
Overview
14
14
years of professional experience
Work History
Senior Electronic Publishing Specialist
Biologics Consulting Group
Wilmington, NC
09.2019 - Current
- Create bookmarks and links in PDF documents to enhance user navigation and accessibility.
- Ability to build applications in eCTD software and troubleshoot issues
- Ensure publication of documents in compliance with eCTD and FDA standards.
- Develop and maintain information files to effectively track submission advancements.
- Utilize RIMSmart to oversee publication and validation of submissions.
- Conduct thorough quality assessments of documents to ensure proper organization and compliance with eCTD submission requirements.
- Facilitate submission processes via FDA's electronic submission gateway.
- Collaborate with clients to troubleshoot and provide solutions for content questions.
- Execute formatting of documents to meet established company specifications.
- Implement process improvements that enhanced workflow efficiency for publishing operations.
- Train staff on best practices in document formatting and publishing.
Electronic Publishing Specialist, Contractor through Greenkey Resources, LLC, Mindlance, & Real Staffing
PPD
Wilmington, NC
01.2012 - 2019
- Assist in the preparation of document output that meets requirements for publishing for both eCTD and CRFs.
- Publish documents that work with sponsor and/or regulatory agency software programs; meeting consistency and security issues for ECTD and CRFs.
- Ensure that all final electronic deliverables meet current regulatory electronic document requirements and guidance.
- Help to develop and implement project-specific processes for sponsors with unique technology requirements and act as the liaison for electronic submissions with the sponsor.
- Serve in a quality review role and be responsible for the thorough review of documents in order to ensure quality that meets or exceeds client’s expectations.
- Compile and publish all documents for inclusion into Clinical Study Reports, INDs, and a variety of other documents; and liaise with Project Manager and Medical Writer.
- Act as lead publisher, for a group of publishers, for large Case Report Form publishing projects.
Background Screening Analyst
Castle Branch
Wilmington
03.2018 - 01.2019
- Responsible for entering records returned from internal and external researchers.
- Evaluate criminal and civil records to determine reportability based on state and federal regulations.
- Enter reportable data into order management system.
- QC entered data
- Collect, analyze, and research data
Freelance Work
Self-employeed
Wilmington, NC
01.2016 - 03.2018
- Editing/Formatting Documents
- Fact-Checking
- Data Entry
- Custom Built Spreadsheets
- Electronic Publishing
Education
Bachelor of Arts - Anthropology with a concentration in Forensics
University of North Carolina, Wilmington
Wilmington, NC05.2017
Skills
- Microsoft Suite
- Boxcom
- Adobe Acrobat Pro/DC, ISI Toolbox
- Liquent InSight Publishing
- RIMSmart
- Rosetta
- Organization
- Detail-Oriented
- Multi-Tasking, Verbal and Written Communications
- Follow-Up
- Initiative/Troubleshooting
- Quality Control
- Editing/Proofreading/Formatting
- Training
- Supervision
Timeline
Senior Electronic Publishing Specialist
Biologics Consulting Group
09.2019 - Current
Background Screening Analyst
Castle Branch
03.2018 - 01.2019
Freelance Work
Self-employeed
01.2016 - 03.2018
Electronic Publishing Specialist, Contractor through Greenkey Resources, LLC, Mindlance, & Real Staffing
PPD
01.2012 - 2019
Bachelor of Arts - Anthropology with a concentration in Forensics
University of North Carolina, Wilmington