Medical Management

Andrew Carter, MPH

212-***-**** **********@*****.*** https://www.linkedin.com/in/andrew-carter-41610037

Professional Profile

Extensive project management experience in clinical, legal and information solutions environments.

High proficiency in gathering business requirements, managing work flows and providing end-to-end client support, including training.

Excellent organizational, analytical and communication skills.

Recognized for consistent performance, creative problem solving and finding innovative efficiencies.

Military Service

United States Navy 1984-1990

Laboratory Technician, Emergency Medical Technician

Experience

Regulatory

Responsible for the technical assistance in developing regulatory strategy for the preparation, submission, and approval of Investigational New Drug (IND) documents/ submissions to the FDA, as described in 21 CFR 312. Assists the Senior IND Manager to provide regulatory guidance to clinical investigators and other clinical staff.

Provides general assistance to managers with the compilation, review and submission of regulatory documentation to the FDA.

Coordinates activities pertaining to the compilation and submission of original Investigational New Drug (INDs) for management and multi-disciplinary team review.

Requests or reviews documentation for Amendments, Annual Reports, Safety Reports, and other submissions required for maintenance of INDs and master files for management review and sponsor approval prior to submission to the FDA.

Submission of all IND documents utilizing eCTD platform.

Researches reports, regulations, guidelines, databases, internal policies, etc. as appropriate in response to regulatory inquiries from other departments and external operating units.

Assists in the collection and review of study specific documentation for each protocol submitted under an IND.

Clinical Research

Initiated and marketed Penn Medicine’s Center for Resuscitative Sciences CPR Hospital Initiated Training Project (CHIP) at Chester County Hospital.

Presentation of clinical study protocol and continued communication with Institutional Review Board (IRB).

Subject Recruitment, screen potential subjects, obtain informed consent and instruct subjects in CHIP clinical study.

Collected and analyzed data for demographic statistics and to address research questions.

Clinical/Medical Experience

Handled multiple aspects of emergency room care, including triage and routine care of patients such as basic first aid, IVs, drawing blood, and dressing wounds.

Served as an EMT and provided ambulance coverage for the Bethesda Naval Hospital base.

Served as an Advanced Laboratory Technician, providing coverage for all functions within laboratory areas.

Project Coordination/Management

Engaged daily with affiliated information officers and business partners to determine stakeholders, gather business requirements and provide timelines for programming and implementation of work requests.

Coordinated communication across work partners to provide status updates, overcome obstacles and develop solutions for the timely completion of work requests/ projects.

Provided leadership in reforming IS work processes to more closely align business requirements and work estimates with department capabilities.

Engaged actively with change management department to insure seamless implementation of work requests.

Researched delivery system reforms, strategic planning, electronic health record implementation and health reform laws.

Business Analyst

Trouble-shot, researched and provided business-wide front end administration for SharePoint.

Provided marketing leadership to generate increased usage of SharePoint sites.

Developed training modules and provided training for SharePoint users.

Developed SharePoint dashboard applications to aggregate various system data points for program management.

Legal/ Administrative

Provided attorneys with relevant medical and legal research, procurement and review of all medical records, identification of expert witnesses, deposition digesting, exhibit preparation and attendance at trial.

Worked with industry and federal regulations regarding settlement of mass tort litigation cases and maintained proper documentation for same.

Assumed responsibility for large case files during transfer of docket between firms.

Maintained budget deadlines and provided accurate accounting of budgetary requirements on a monthly/quarterly/yearly basis.

Engaged with counsel to accurately review and process all settlements to ensure proper and timely payment.

Processed and provided timely payment of all attorney and vendor invoices; updated database with new cases.

Work History

Leidos Biomedical – Frederick, MD 2017 – present Regulatory Associate

AmeriHealth Caritas – Philadelphia, PA 2014 – 2016

Project Coordinator – IS, Business Analyst –Business Intelligence

Sea & Air International - New York, NY 2010 – 2012

Project Coordination/ Sales

Back Page Sports Bar – New York, NY 2008 – 2010

Bartender/ Event Coordination

McDermott, Will & Emery – New York, NY 2003 – 2008

Legal/Administration

United States Navy – Bethesda, MD and Groton, CT 1984 – 1990

Medical/Clinical

Education / Professional Associations

West Chester University - Master of Public Health/Health Care Management, 2016

Temple University - Bachelor of Arts Theater Arts/Political Science, Magna cum Laude, 1995

George Washington University Associate of Science Medical Laboratory Technique, 1991

Member of the American College of Healthcare Executives (ACHE)

Technical Skills

Microsoft Office: Word, Excel, PowerPoint, Outlook, Trackwise, eCTD

Concordance, CMS Open, Lexis/Nexis, Westlaw, basic SPSS, ArcGIS

Tier 1 SharePoint administration

cGMP certified, GCP trained

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