Mary L. Waters CV - CTD Regulatory Affairs

Mary L. Waters CV – CTD Regulatory Affairs

Professional Experience and Accomplishments

 Eighteen years’ experience in the Food and Drug Administration (FDA) regulated environment including clinical research and product manufacturing.

 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 Visit; 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.
  • Reviewed, monitored, and audited controlled documents including archived paper and electronic records.
  • 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.

Regulatory Specialist

  • Managed the electronic common technical documents (eCTD) and structured product labeling (SPL) software for Food and Drug Administration (FDA) e-submissions.
  • 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.
  • Developed new procedures and processes which significantly improved the staffing approval and submission delays.

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.
  • Contracts, Acquisition and Program Management
  • Ten years experience in strategic planning, staffing, budgeting, and cost proposal preparation.
  • Program Manager, APHIS task order contract. Managed task orders on a day-to-day basis, monitored and analyzed actual against budgeted cost, and resolved outstanding account receivable issues.
  • Prepared and analyzed revenue projections; overhead and direct labor forecasts with annual budgets up to $180 million.
  • Prepared and presented monthly and quarterly status reports to senior management.
  • Created cost models and documentation to respond to Requests for Proposals or Quotations.
  • Created, reviewed and implemented contracts for terms and conditions, modifications and funding actions.
  • Supervised customer invoice reconciliations and billing discrepancies.

Technology Management Skills

  • Exceptional computer skills using current Microsoft Office Suite (Word, Excel, Power Point, Access, Visio, Project); Documentum, SharePoint, Open Text (LiveLink®); AdobePro; Corel WordPerfect and Quattro Pro; Lotus 1-2-3, Dbase, Paradox, and Deltek Accounting Modules.
  • Thorough knowledge on federal government processes, procedures, and terminology.

Relevant Work History

  • HHS, ASPR, BARDA, RQA 2010 – Present
  • NBACC/BNBI (DHS) 2010 – 2010
  • U.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