Melissa S. Hanley
**** ****** ***** ( Morrisville, PA 19067 ( Cell 215-***-**** (
**********@*****.***
Objective To continue to expand my skill set and establish a
career path within a corporate environment where,
professionalism, leadership, and strong work ethic
are valued.
Qualifications
Highly motivated, team focused and goal oriented
with attention to details.
Strong organizational and time management skills
for facilitating consistent productivity.
Data entry experience from entering medical records
in database.
Work well with people with an ability to understand
their needs.
Computer savvy with proficiency utilizing Microsoft
Excel, Word, Access, Outlook, Adobe Acrobat 8.0,
Webtrader, Ariba and other databases and Medical
Terminology.
Skilled in working under tight deadlines and
multitasking.
Extensive experience in an office environment with
8 years in the Pharmaceutical industry.
Excellent communication and organizational skills
with attention to detail.
Education September 2010 - Present Buck County Community
College Newtown, PA
Currently working toward obtaining a degree in
Sonography
June 1999
Pennsbury High School Fairless
Hills, PA
High School Diploma
Work Experience 2005-2010 Johnson & Johnson
Horsham, PA
Senior Archivist, Benefit Risk Management
Responsible for electronic and manual submissions
of individual case safety reports to Regulatory
Authorities and business partners.
Managed submissions per standardized operating
procedural documents, produced CIOMS/Medwatch
documents for fax/email distribution.
Global distribution of Adverse Events to Regulatory
agencies and business partners.
Participated in multiple audits and inspections by
FDA and business partners.
Assisted in LCR training for ISO Associates,
Coordinators, PvP's and Managers for a better
understanding of the outbound process.
Cross trained on Inbound process and Spanish
Translation process for case processing.
Supported new technologies and process changes by
moving from burning CD's and faxing to emails for
partner distribution and use of the internet for
FDA attachment submissions vs. burning CD's
Work quickly to resolve challenges and issues with
prompt attention to urgent priorities.
2000-2005 Johnson & Johnson
Spring House, PA
Archivist/Document Management, Benefit Risk
Management
Document Management point person for preparing
adverse event case files for offsite storage and
organization of onsite case files to minimize
retrieval time.
Coordination of on-site and off-site filing aspects
of the adverse event case files. Received Encore
award for fileroom project.