Project Manager Management
Resume:
Mary L. DuFort
Cheswick, PA *5024
(H) 724-***-**** ~ (M) 804-***-****
****.******@*****.***
PROFILE
Experienced professional with a strong working knowledge project management for organizations requiring oversight. Effective guidance to senior level executive management relating to liaison relations at state and federal industry levels. Confident senior project manager with a defined practice of achieving a positive return on investment.
HIGHLIGHTS OF QUALIFICATIONS
Management Skills
Serves as senior level representative for regulatory interface with over 15 years of experience providing oversight of regulatory activities and development of comprehensive administrative compliance programs.
Project Manager for operational & business administrative processes for global business segments.
Works closely with cross-functional senior management teams in documenting, designing, defining, reviewing information prior to release and for providing daily support to client executive management.
Supervises in review, training, execution and mobilization of application licensing teams; defining deliverable structure and proposing proactive solutions and resolutions.
Manager for confidential business submissions to State and Federal Agencies.
Excellent communicator with conceptualization between regulatory agencies, business segment personnel and senior level management.
Provides regulatory compliance, testimony, litigation support, environmental permitting and other consulting services.
Professional demeanor, poise under pressure, and the ability to maintain the highest level of confidentiality leadership interactions of operational excellence and methodologies to achieve success.
Excellent problem resolution for multiple site critical problem resolution with decisiveness and people management skills.
Computer Skills
Microsoft Windows XP Professional; Word, Excel, PowerPoint & Outlook, Windows 7 Professional, Lotus 8, Oracle DBMS, SAP, ISO 9000 & 9001, HIPAA & FDA; E-Signature Records Management, ADOBE Professional, UNISYS 80, Oracle, DES Encryption, SAP & SharePoint web-based platform management programs.
PROFESSIONAL EXPERIENCE
Thermo Fisher Scientific, Inc., Pittsburgh, PA Nov 2010 - Present
Regulatory Affairs Specialist – Fisher Scientific Company L.L.C. Contract
Perform daily regulatory reviews on new product applicability, utilizing internal screening processes against federal, state and global regulations.
Involved in the daily regulatory, compliance activities within Product Safety/Regulatory Group acting as a generalist/specialist.
Developed comprehensive assessment of site- specific locations and registrations with instant validation of state verifications.
Designed complex interactive web-based applications and reference data linked to all regulatory agencies.
Liaison with regulatory agencies negotiating and resolving complex issues that support operational methodologies and issuance of difficult state registrations.
IBM Regulatory Services, Pittsburgh, PA Jun 2010 – Oct 2010
Security & Risk Management/ RDL Consultant
Regulatory Delivery Leader Consultant assigned to multiple clients working with account executives and multi-tier project leaders regarding security and risk management on regulated and non-regulated accounts.
Interface with IBM support teams; provide training regarding client specific regulatory requirements.
Manage multiple mainframe networks for regulatory requirements designed for specific customer requirements requiring DES Encryption and Digital Certificates.
Cegedim Dendrite International - Pittsburgh, PA /Richmond, VA May 2007 - Jun 2010
Federal & State Services Manager:
Facilitated and achieved cost efficient domestic and international movement of pharmaceutical drugs and product lines.
Managed ongoing projects for site specific locations. Development, operations and training of personnel pertaining to permit applications, including regulatory interface, site expansion, and amendment and modification changes.
Liaison with regulatory agencies negotiating and resolving complex issues..
Provides continuous public relations to regulatory agencies regarding the due diligence activities preformed at site specific locations, providing administrative violation and resolutions /remediation.
Ensures continued compliance by coordinating and monitoring client assessments, electronic data review, reporting and continuous communication.
Coordinating implementation of prescription drug manufacturing and wholesale distribution requirements; Chain of Custody (Pedigree) and HIPAA compliance for specific clients.
US Department of Justice - Washington D.C./Martinsburg, WV Aug 2004 - Mar 2007
National Firearms Act Branch (NFA):
Federal Contract/ SA:
Managed operational and administrative support to Branch Chiefs
Appointment: US Federal Court – Chain of Custody; Implementation of records management.
Provided guidance on importation, manufacturing, transferring defense articles to the Firearms Industry Personnel regulated under USC 26 CFR Part 53 of the Federal Firearms Regulation.
Responsible for providing oversight and guidance of U.S. Export control regulations Export Administration Regulations (EAR) and International Traffic in Arms Regulations (ITAR).
POC (Point of Contact) for the Department of Defense 2006 Mandated Law Enforcement Inventory; referencing USC 27 CFR, Chapter II.
Virginia Medical Associates - Fair Oaks, VA Apr 1992 - Jan 1996
Occupational Health Nurse:
OSHA & DOT Testing Coordinator.
Q/A Management, Urgent Care, Family, Environmental Health & Out Patient Float.
Code Enforcement Official: Occupation Health and Safety, HIPAA compliance, EPA mandated enforcement of NPDES Water Quality, Title V & ACDP Air Quality validation and compliance.
Assembled the collection, review and implementation of protocol and documentation for ICD-9 CPT revenue coding and Federal and State regulated agencies.
Maintenance and validation of environmental permits for corporate clients.
Managed and developed site specific SOP’s, Annual Reports, Safety Reports, requirements per EPA, DOT & OSHA Regulations.
United States Military - Army Jun 1982 - Oct 1992
Non Commissioned Officer
Q/A Supervisor: Military Entrance Processing Station - Chicago, IL. (MEPS)
Implementation and Maintained Q/A & Q/C teams throughout all medical departments
Manager DOD HIV/ Drug Test Controller resulting in 99.9% accuracy rating.
Evaluation of application and security requirements on Oracle systems procedures to determine compliance with DOD Regulations, SOP’s and Chain of Custody procedures, as well as overall confidentially and effectiveness of secured electronic program transmissions.
Supervisor Out-Patient Services: Southern European Task Force, Vicenza, IT (SETAF)
Senior Coordinator Rapid Deployment Contingency Disaster Exercise.
Medical Security POC (Point of Contact) International Chain of Custody returning to CONUS (Continental United States).
EDUCATION
University of Texas, Academy of Health Sciences – San Antonio, TX
BSN 1983 - 1986
US Army, Medical Aviation - Ft. Rucker, AL,
Aviation Medicine 1986
Federal Training Academy, Bad Tolez, Germany
Professional Leadership 1990
Towson State University -Towson, MD 1995
OSHA Credential
University of Maryland - Baltimore, MD 1995 - 1997
BA
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