Mary L. Waters CV – CTD Regulatory Affairs

Mary L. Waters

Nineteen years’ experience in the Food and Drug Administration (FDA) regulated environment including clinical research, product manufacturing, and CTD regulatory affairs.

Senior Consultant

  • Provides technical advice and expertise in electronic CTD regulatory affairs publishing services and submissions.
  • Provides technical advice and expertise in the FDA eSubmitter software for electronic Medical Device Reporting (eMDR) 3500A publishing services and submissions.
  • Performs quality control and validation on all documents ensuring correct FDA attributes and specifications.
  • Established and maintains electronic repository for regulatory, reference material, and other product related documents for retrieval ensuring version control.
  • Secure FDA email account.

 

Document Control – Records Management Liaison, Subject Matter Expert

  • Organized, tracked and maintained all documents for the Biomedical Advanced Research and Development Authority (BARDA); electronic filing system (Documentum and eRoom). Records include administrative, training, regulatory library; Program/Project regulatory documents: Records of Review, Audit Reports, Site Visits; Standard Operating Procedures; department correspondence; Quality Plans and Agreements; and personnel records.
  • Created master BARDA and ASPR SOP Templates, forms, process maps; created Division SOP Training Plans and Training Database; provided additional training and support throughout BARDA and ASPR.
  • Assistant Secretary for Preparedness and Response (ASPR) Quality Initiative (Lean Six Sigma) Project: BARDA SOP Improvement Process. Identified and analyzed problems, extracted data from various sources for reports, analyzed records for accuracy; compiled and consolidation data; provided updates to management. Prepared final report for ASPR and BARDA Senior Staff.
  • Organized, tracked, and maintained regulatory records for the Office of The Surgeon General (OTSG) Department of Defense (DOD) Chemical Biological Medical Systems (CBMS) eighteen products ensuring compliance with Agency regulations and guidelines.
  • Established and maintained electronic repository for regulatory, reference material, and other product documents for retrieval utilizing Documentum, Open Text LiveLink®, or Microsoft SharePoint.
  • Ensured documents were complete with appropriate metadata, attributes assigned, and filed in correct location.
  • Resource and Working Group Member for: ASPR’s SOP Working Group; DOD Initial Requirements Working Group, SOP Template Working Group, and Protocol Template Working Group.

 

Electronic Records Specialist

  • Managed the FDA eSubmission software for the electronic Common Technical Documents (eCTD) and Structured Product Labeling (SPL).
  • Prepared documents for review, submission, and approval to the U.S. Army Medical Research Materiel Command (USAMRMC) Human Subjects Research Review Board (HSRRB) and the Animal Care and Use Review Office (ACURO). Coordinated protocols between pharmaceutical managers, subcontractors, and approving officials.

 

Training and Education Specialist

  • Established the SOP Training Program for BARDA staff.
  • Determined, evaluated, and organized training needs and requirements for personnel based on Division, agency regulations, and guidelines.
  • Conducted SOP Training sessions for each Division (161 trainees).
  • Selected appropriate mode of delivery: classroom instruction, in-house sessions, web based seminar, or self-paced.
  • Established, updated, and maintained training materials, training database, and personnel training records.

 

Protocol Administrator

  • Coordinated and prepared documents for submission to the FDA: Investigational new drug (IND), new drug application (NDA), biologics license application (BLA), and pre-marketing application (PMA). Prepare documents for review/submission to the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) Institutional Review Board (IRB), and the USAMRMC HSRRB.
  • Provided regulatory and quality assurance guidance to 12 principal investigators (PIs) and 10 clinical research nurses in the Special Immunizations Program (SIP), USAMRIID.
  • Maintained regulatory files for 30 active clinical research protocols including drug inventory control and accountability records.
  • Scheduled, compiled, and maintained compiled Continuing Review Reports (CRRs) for each protocol. Assisted PI with compiling data, reviewed for accuracy and completeness. Monitored status to ensure PIs met submission deadlines to the IRB.
  • Conducted internal/external audit and monitoring visits.
  • Established and maintained electronic and paper repository of regulatory and other product documents for reference/retrieval by implementing a state-of-the-art medical record and document tracking system for approximately 650 active medical records; 4,500 case report forms; and 60,000 archived medical records.
  • Prepared manufacturing records for vaccines and biologics (batch, solution preparation record, and validation qualifications).
  • Designed protocols, informed consent documents, case report forms, recruiting advertisements, and SOPs.
  • Ensured SIP Clinical staff member’s tasks completed complied with federal regulations and DOD policies and procedures.
  • Medical Research Information Technology System (MeRITS). Resource member actively involved in the Initial Requirements Working Group, SOP Template Working Group, and Protocol Template Working Group.

 

Technology Management Skills

  • Exceptional computer skills using current Microsoft Office Suite (Word, Excel, PowerPoint, Access, Visio, Project); AdobePro; Documentum, SharePoint, Open Text (LiveLink®); Box
  • Lorenz docuBridge, AuthorBridge and eValidation software
  • FDA eSubmitter Software, FDA ESG account, FDA Secure email account

 

Relevant Work History

  • Hartmann Willner, 2016 – Present
  • HHS, ASPR, BARDA, RQA, 2010 – 2016
  • NBACC/BNBI (DHS), 2010 – 2010
  • S. Army (DOD Contractor), 1999 – 2009
  • MedImmune, Inc.,1997 – 1999
  • Digicon Corporation, 1994 – 1997
  • ARC; Technology Application and Services, Inc, 1987 – 1993
  • National Institutes of Health (NIH), 1974 – 1982

 

Memberships

  • Regulatory Affairs Professional Society (RAPS)
  • Drug Information Association (DIA)

 

Relevant Education and Training

  • Lean Six Sigma, Yellow Belt

Security Clearances

  • DOD National Agency Check (NAC), DHS Secret