Senior Trial Master File Specialist, Clinical Operations - The Emmes Company, LLC - Frederick, MD (Remote)
(2020-01 - 2024-12)
- Executed key TMF system administrator role and duties from study startup through closeout and final archiving in accordance with company guidelines and work instructions (e.g., TMF set-up, quality management, reports and metrics, TMF quality control (QC)/ quality assurance (QA) activities, etc.)
- Managed TMF performance objectives for end-to-end processes ensuring quality, timeliness, and completeness throughout the lifecycle of the study by overseeing and/or ensuring ongoing reviews to confirm documents are collected and maintained per ICH guidelines and global regulatory requirements.
- Developed and maintained TMF Plans and Indexes, organizing TMF content in alignment with the CDISC TMF Reference Model.
- Supported Study Teams to proactively maintain current Expected Documents List (EDL) counts and to file essential documents promptly according to TMF Plans and Indexes, including adjustments due to unanticipated events during trial conduct.
- Delivered biweekly TMF updates to internal/external customers, furnishing them with the latest TMF metrics.
- Collaborated with functional area representatives to guarantee TMFs are submission and inspection-ready.
- Participated in Quality Assurance audits and/or regulatory authority inspections.
- Identified study-specific TMF compliance gaps (missing or low-quality documents) and tracked resolutions to closure quickly.
- Escalated issues and/or process improvement suggestions and collaborated cross-functionally to define and implement solutions, Veeva Vault system changes, or corrective and preventative actions.
- Contributed to the development and improvement of department-level and cross-functional Standard Operating Procedures (SOPs), processes, systems, tools.
- Created and updated training materials and guidelines for digital records/TMF, offering training and guidance to staff as required.
Regulatory Document Specialist 3, Regulatory Operations - The Emmes Company, LLC - Frederick, MD (Remote)
(2019-01 - 2020-12)
Regulatory Specialist, Regulatory Publishing Solutions (RPS) - Pharmaceutical Product Development, Inc. (PPD) - Wilmington, North Carolina (Remote)
(2017-01 - 2019-12)
Publishing Specialist, Electronic Publishing and Submission Management (EPSM) - Pharmaceutical Product Development, Inc. (PPD) - Wilmington, North Carolina (Remote)
(2013-01 - 2017-12)
Onboarded to lead the implementation of an Electronic Document Management System (EDMS) and establish Trial Master File (TMF) archival procedures.
- Played vital role in the remediation of more than 300 boxes of TMF documents for a government client organizing and archiving eTMF content under the auspices of the DIA TMF Reference Model.
- Provided oversight, created training materials and performed training for 20+ contractors hired to assist with uploading TMF documents to the client's electronic regulatory document tracking system.
- Conducted document quality reviews, earning the 2017 Pharmaceutical Product Development (PPD) Employee Achievement Award.
- Transitioned to support Electronic Publishing and Submission Management (EPSM) department, publishing documents for regulatory filings (Investigational New Drug [IND]/New Drug Application [NDA]/Biologic License Application [BLA]).
- Published 200+ client deliverables meeting regulatory requirements, earning the 2017 PPD Employee Achievement Award utilizing technology proficiencies in Adobe Acrobat Pro, ISI ToolBox, Liquent InSight Publisher & Validator, and LORENZ eValidator.
- Coordinated BLA submission for key marketing application including document organization, publishing, and SharePoint upload (2,885 files; 693 folders) ensuring electronic Common Technical Document (eCTD) compliance.
- Won PPD Regulatory and Pharmaceutical Services Excellence Awards (2018 and 2016) for collaboration, organization, and leadership.
- Contributed to development of Standard Operating Procedures (SOPs) and trained staff on document management processes.
Senior Manager, Publishing Operations - DynPort Vaccine Company, LLC (DVC), A CSC Company - Frederick, MD
(2011-01 - 2013-12)
Manager, Publishing Operations - DynPort Vaccine Company, LLC (DVC), A CSC Company - Frederick, MD
(2008-01 - 2011-12)
Senior Publishing Specialist, Regulatory Affairs - DynPort Vaccine Company, LLC (DVC), A CSC Company - Frederick, MD
(2007-01 - 2008-12)
Submission Specialist, Regulatory Affairs - DynPort Vaccine Company, LLC (DVC), A CSC Company - Frederick, MD
(2003-01 - 2007-12)
Advanced through various roles within a company specializing in product development programs for government agencies and consulting services for biotech and pharma industries.
- Implemented and maintained an electronic document management system ensuring consistency and defining procedures for FDA submissions, business proposals, client deliverables, and other documents.
- Received CSC President's Award (2012) for managing 200+ high-quality client deliverables without missing a deadline since 2008.
- Earned CSC White Hat Award (2009) for exceptional publishing expertise resulting in FDA submissions and business proposals generating substantial revenue growth.
- Established the Publishing Operations Department in recognition of exemplary performance and numerous contributions as a member of the Regulatory Affairs Department.
- Directed submission team, vendors, and other personnel to meet service publication requirements, including document design, writing, editing/revising, printing, and fulfillment.
- Reviewed published materials and recommended revisions to satisfy quality standards.
- Uploaded and routed documents for review/approval in NextDocs electronic document management system and maintained document archives.
- Served as a key contact throughout the introduction of EXTEDO electronic publishing software, assisting with testing and qualification of the new system.
- Played a key role in creation of a company-wide style guide to define proper formatting criteria for all publications and delivered training to functional groups on document management procedures.
Consultant/Proposal Coordinator - Kelly Anderson and Associates, Inc. - Alexandria, VA
Submission Specialist, Regulatory Affairs - Human Genome Sciences, Inc. - Rockville, MD
Regulatory Associate, Regulatory Affairs - Human Genome Sciences, Inc. - Rockville, MD
Documentation Specialist, Regulatory Affairs - Human Genome Sciences, Inc. - Rockville, MD
Executive Assistant, Regulatory Affairs - Human Genome Sciences, Inc. - Rockville, MD
