MARIA C. CARLUCCI, BSN, RN
721 Winchester Road
Broomall, PA 19008
WIDENER UNIVERSITY SCHOOL OF LAW, Wilmington, DE
J.D. expected May 2004
Class Rank: Top 30% (GPA 3.097)
Honors: Dean’s List Fall 2000 & Spring 2002 Semesters
Awards: Certificate of Achievement, Administrative Law, Spring 2002
Chadwick Memorial Scholarship, 2001-2002
Activities: The Delaware Journal of Corporate Law
Health Law Society Member
UNIVERSITY OF SCRANTON, Scranton, PA
B.S.N., awarded May 1994
Merck & Co., Inc.
Blue Bell, PA
Acting Associate Manager: December 2002 to Present
Responsible for 4 direct reports. Participate in all matters regarding managerial duties. Additional responsibilities include supervisory review of IND and NDA reports while maintaining worldwide and FDA reporting regulations. Review of IND reports includes maintaining compliance with MAPP 11 and MAPP 13 and facilitating seven day phone calls to FDA. Execute daily distribution of work to each individual team member. Maintain an open-door policy for team members in order to provide problem solving or answering questions to specific situations.
Adverse Experience Reporting Associate: June 2001 to December 2002
Assumed a leadership role among the team which included providing daily
managerial and problem solving to Coordinators. Performed supervisory review
on reports on NDA and IND reports, as well as, all legal cases. Continued to orient new-hires, act as liaison between Department and Merck National Service Center, served as team leader for facilitating NDA submissions to FDA.
Adverse Experience Reporting Coordinator: June 1999-June 2001
Processed marketed, investigational, international and domestic adverse event reports in compliance with worldwide and FDA regulations. Continued to increase responsibilities and work volume while working both independently and collaboratively on projects. Served as point person for organizing and submitting periodic submissions to FDA.
HOSPITAL OF THE UNIVERSITY OF PENNSYLVANIA
Staff RN: August 1994-June 1999
Provided care to complex, critically ill patients in a twenty-four bed Surgical
Trauma Intensive Care Unit. Experiences included: hemodynamic monitoring, ventilator management, EKG interpretation, dialysis with Continuous Venovenous Hemofiltration & Dialysis, and management of intracranial pressure via intracranial bolts and ventriculostomy drains.
Additional Awards: Spirit Award, Merck, November 2003
Achievement of Excellence, Merck 2002