SUMMARY OF EXPERIENCE
Regulatory Affairs Administrative Professional with over 10 years supporting upper level management in multiple business disciplines. Strong interpersonal and written communication skills with a keen ability to relate to all levels within an organization.
PHARMACEUTICAL INDUSTRY EXPERIENCE
ZIOPHARM Oncology, Inc. Regulatory Affairs/Quality Assurance/Drug Safety – Boston, MA
Executive Assistant/Regulatory Assistant, 06/07 – 07/08
Assembled information from other departments for initial IND submissions and subsequent updates including completion of FDA Form 1571, authoring and formatting Tables of Contents, confirmation and compilation of new Investigator curriculum vitae, FDA Form 1572, licenses and site questionnaires from Clinical Trial Managers
Updated and maintained electronic and hard copy IND submission files, correspondence files and tracked information for departmental reference
Updated databases for Regulatory Affairs, PreClinical and Quality Assurance reports as needed
Compiled drug product stability tables for different lot numbers for manufacturing
Assisted Drug Safety with assembling SAE and non-SAE information for site and agency notification letters and submissions
Assisted Drug Safety in obtaining follow up information of AE cases from study sites and populated database tables with the data for departmental tracking purposes
Organized and maintained drug safety files
Ordered and tracked Clinical Trial Material for study sites within the US, Canada and India
Maintained and updated Drug Order filing both electronically and hard copy per site
Weekly inventory and reporting of Clinical Trial Material shipments for Quality Assurance
Assisted Quality Assurance in SOP updating; new and existing employee SOP training and tracking, and maintenance of employee training files for audit purposes
Developed and authored Work Instructions for Quality Assurance SOPs and Regulatory Affairs SOPs
Scanned and filed – both electronically and hard copy – drug substance and drug product batch records and release data for CMC/QA
Compiled various articles and papers for reference for FDA submissions
Ordered and coordinated FDA webinar meetings as requested
Coordination of departmental meetings on and off site, formal events and travel both domestic and international for management up through C-level.
Scheduled and contributed in weekly Clinical and Regulatory update meetings
Researched outside information on other pharmaceutical company submissions to the FDA, industry meetings and educational offerings for training purposes
Assisted in other administrative duties such as phone coverage, office supply ordering, mail, calendar management for multiple executives, faxes, calculating, completing and submitting expense reports for managers, copying and filing.
REAL ESTATE INDUSTRY EXPERIENCE:
B&B Demolition, Excavation & Real Estate Svcs., LLC - Tampa,FL/Tewksbury,MA
Property Manager/Broker Assistant, 08/05 – 05/07
Composition of marketing packages for procurement of parcels for development
Maintain correspondence with potential buyers/tenants, assisting with budget preparation for build-outs and improvements, and utility tracking for existing properties
Set up and maintenance of purchase and sale files, lease files and investor correspondence
Authored lease abstracts, contract addendums, vendor and tenant correspondence from principals
Acted as liaison between Florida and Massachusetts offices
Maintained and audited financial records, including rent collection, accounts payable and all applicable state, sales and property taxes
Coordination of travel arrangements between Florida and Massachusetts offices, weekly progress meetings and maintenance of principal’s calendar
Bi-annual company event planning
World Savings – Tampa, FL
Loan Origination Specialist, 10/02 – 07/05
Obtained new business through on-site cold-calling of mortgage brokers and realtors
Developed sales tools and provided training for brokers and realtors on products offered to increase pipeline and retail prospects
Sponsored and planned social events for and with retail accounts to increase exposure to products
Met and exceeded accelerated sales goals monthly beginning at $225,000 up to $2.7 million by the 7th month
Compiled information from both wholesale and retail accounts for application, reviewed credit worthiness of applicants and restructured program options to their situations, audited executed loan documents upon acceptance and closed the sale and file with title company.
The Toni Everett Company – Tampa, FL
Executive Leasing Representative, 07/01 - 11/04
Created marketing packages for luxury properties located in elite Bayshore Boulevard area
Assisted the sales force of a high-rise condominium conversion project with potential buyers and sellers in maintaining all of their property management and leasing of existing properties in-house with our company.
Negotiated purchase and sale agreements, property leases and development contracts as a licensed Florida realtor
Personal assistant to the owner of the company – coordinating company events, travel arrangements, fund-raising for private interests, hiring and management of personal house staff.
Jones Lang LaSalle – Tampa, FL
Tenant Services Representative, 06/00 – 07/01
Provided administrative support to the General Manager and the Property Manager of the commercial properties contracted, including general correspondence to investors, tenants and contractors, light phone responsibilities, and calendar management.
Abstracted leases for new tenants, CAM reconciliation, preparation of vendor contracts
Assisted with annual budget preparation for properties
Coordinated company events and tenant social functions
Conducted walkthrough inspections of leased space with vendors and tenants
Assisted accounting in delinquent rent collection and process of eviction.
Hunt Douglas Real Estate Services, Inc.
Junior Property Manager, 06/98 – 12/99
Compiled information on existing leases for abstracting and budget preparation
Assisted in vendor relations by placing orders, negotiating payment schedules and conducting initial inspections and closeout inspections of jobs
Worked in conjunction with accounting and property manager to reconcile common area maintenance charges per tenant
Assisted property manager in developing marketing campaigns to draw more companies to the buildings under the owner’s management
Developed positive tenant/management relations by providing personal service and coordinating on-site social events to show appreciation.
Cushman & Wakefield of Florida – Tampa, FL
Executive Assistant, 06/97 – 06/98
Provided exceptional administrative support to nine executive level brokers including correspondence to potential business, maintenance of confidential information, scheduling social events and other administrative duties as requested.
Maintained separate C-level executive calendar, assisted in both company and personal travel arrangements
Supervised the personal assistant and child care provider for C-level executive.
8/2007 – Present - Member Drug Information Association
4/2007 – Present - Notary Public – Massachusetts
1/2005 – 8/2005 - Notary Public - Florida
1/1997 – Present - Licensed Realtor, Florida Association of Realtors
American Institute of Banking - Dover, DE
Associates – Finance
University of Delaware - Wilmington, DE
6/2008 ISI Toolbox and Writer – Training 2 days Boston, MA
3/2008 Regulatory – The IND, Phase I – DIA Seminar Baltimore, MD
11/2007 ISI Life Sciences Forum – Training Boston, MA
8/2007 Introduction to Drug Overview – DIA Seminar Princeton, NJ