Miriam R. Lampon

Home 908-***-****

E-mail: lb5sb1@r.postjobfree.com

Education

Liberal Arts Associates

Warren County Community College

Legal Office Specialist Certification

Cittone Institute 1995

CFR 21 Part 11 Certification Clinical Studies 2002

Skills

Windows Based Computer Applications

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Visio

Snagit

Ariba

ComplianceWire - LMS

Lotus Notes

Outlook

Schedule + Intranet and Internet

NetMeeting

WebEx Meeting

Executrain Expense

Expense Reporting

Expense Link

Dashboard

Documentum

Documentation Specialist

eDocs

ePrime

Wisdom

cPDM

CTO / AOG Travel Oral and Written Communications•

Bilingual - Spanish

Customer Service

HR Recruitment Process•

Assessment and Evaluation Training Materials

Budgets

Knowledge of ISO and OSHA Standards

Business Law

Litigation

Real Estate

Wills and Estates

Briefs and Motions

Professional Experience

CMS / UCHC - UMDNJ, Annandale & Clinton, NJ 2008 – 5/2009

Administrative Assistant to Medical Service Team

Support all internal medical team members and dental business unit with daily operations in facilitating medical services while tracking, recording and reporting daily functions of clinical treatment team to the New Jersey Dept. of Corrections.

All vendor procurement, tracking, processing logs; as well as credentials, record retention of all state, federal and DOC files updates and site liaison for human resource reporting directly to corporate offices.

Cordis Corporation, a Johnson & Johnson Company, Warren, NJ 10/2004 – 9/2006

Executive Administrative Assistant to the Worldwide Director of CPS

Primarily assisting the Training Director with internal business issues regarding human resources reports / interview process, budgetary issues, general procurement; as well as cash asset requisitions for all sites. Arranging all travel itineraries and filing report to his’ superior.

Providing support to a newly developed international business unit consisting of 125 staff members worldwide to standardize e-learning materials in compliance to FDA standardizes. Daily interactions creating and implementing access for domestic and international staff members share drive folders for retention of training curriculum in either format of presentations or CBTs. These materials are reviewed, modified, assessed with additional criteria to be deployed internationally for all sites.

Provided internal clients with logistical setup session, print production, and reviewing test scores for GCP and GMP training conducted for internal and external clients in accordance to regulatory agencies.

Initial implementing of intranet webpage logistics in conjunction with IM contacts for the development of the home page for all Cordis employees.

All Ariba procurements consisting from purchasing hardware, software, general office supplies, and contractual agreements within the “Evergreen” vendor approval list. An accomplishment of this was the

successful completion of two Worldwide Meetings of all upper level personnel consisting of 55 international staff members to participate in a meeting held in New Jersey. All logistical details, contract negotiations and approved by corporation legal provided a savings of $13,500 on the accommodations over a five-day period per session.

Pharmacia Corporation, Peapack, NJ 01/2002 – 09/2002

Executive Assistant to R&D Clinical Research

Liaison for clinical study reports, adverse reactions and monitoring of investigative sites in accordance to contractual agreements set forth by corporate legal.

Formatting foreign study reports according to company guidelines in preparation for FDA submissions and inputting into Predict, Wisdom or e-Docs data systems.

Calendaring, teleconferences, internal and external meetings, travel authorizations, extensive travel itineraries on corporate jet, web page updates, and presentational materials for Vice President’s, Directors, Investment Lawyers, and Clinical Research Associates

Merck & Company, Inc, Whitehouse Station, NJ 11/2000 – 06/2001

Executive Assistant to Human Resource Director, Operational Excellence – OE

Providing support to director and other team members on scheduling of events, logistical details and preparing presentational materials for executive divisional conferences to enabling growth and development of new strategies for employees worldwide.

Scheduling new recruitment interviews for external candidates and providing security clearances as well as possible accommodations during this process.

Procurement of all office supplies and budgetary cost for OE.

Prudential Insurance Company of America, Livingston, NJ 08/1998 – 10/2000

Executive Administrative Assistant to Director, Marketing Communications of Group Insurance•

Procurement responsibilities for PC equipment, software applications, systems deployment, security clearances, office supplies, budgetary and 1998 accrual cost for two business units consisting of 60 staff members.

Coordinated and prepared quarterly Town Hall meetings working closely with senior management, as well as ad hoc presentations throughout.

Elizabeth General Medical Center, Elizabeth, NJ 02/1998 – 07/1998

Executive Administrative Assistant to VP Corporate Marketing, Business Planning, and Development

Provided secretarial support to the VP and other members of his department. Assisting all members with reports to external consultants in preparation for due-diligence, Certificate of Need and L.A.B. presentation shown to the New Jersey, Department of Health, and Licensing Division in preparation for the merger.

Sorted, formatted, distributed correspondence for all executive levels; as well as managed the corporate conference area, scheduling meetings, agendas, itineraries, travel arrangements, preparing presentations, disbursements and requisitions.

Merck & Co., Inc., Rahway, NJ 12/1996 – 01/1998

Executive Administrative Assistant (Floater) MRL

Assisted associates with company orientation, scheduling of mandatory clinical courses, legal documentation and provided administrative support to associates, as well as, four MPC's in compliance with clinical studies, adhering to contractual agreements, grants, and corporate compliance.

Executive Administrative Assistant to VP Endocrinology and Metabolism – MRL•

Performed all secretarial duties including correspondence, agendas, and itineraries, scheduling internal and external meetings, and coordinating executive travel arrangements.

Executive Administrative Assistant to Senior Director and Associate Director Clinical Research Operations - CROPS (Latin American Studies)

Processed communication correspondence with various subsidiary personnel utilizing internal, external, inter-office, intranet and internet mail systems. •

Prepared executive itineraries consisting of scheduling meetings, agendas, travel arrangements, accommodations, presentations and expense reports.

Performed quarterly input of subsidiary financial cost projections, expense - disbursement reports, maintaining clinical, administrative and subsidiary organizational files and binders in compliance to company procedures.

The BOC Group, Murray Hill, NJ – Contractual Manpower 10/1995 -11/1996

Administrative Assistant for various departments: Information Systems, Corporate Legal and Expatriation (HR).

Handled daily correspondence, relocation processing, expense reports, employment agreements, formatting database to implement new information systems, assisting expatriate employees abroad with personal expense reports, tax matters and documentation.

Ohmeda Pharmaceutical Products Division Inc.

Executive Administrative Assistant to Operation Directors

Performed secretarial functions, processing personal expense reports, travel arrangements, scheduling meetings and conferences.

Pitney, Harding, Kipp and Szuch, Florham Park, NJ 02/1995 – 09/1995

Administrative Assistant to the Accounting Department

Processed all external, interoffice and e-mail, composing correspondence and updating log books, processing and sorting accounts payable and receivables, researching client files, maintaining and tracking all files for various departments: Accounting, Data Processing and Collection.

Goya Painting Inc., Newark, New Jersey 06/1986 – 02/1993

Office Manager

Assisted in financial evaluation, marketing services, processing health care benefits for union and non-union personnel, supervising staff and field operatives, administrative arbitrator of labor wage agreements and disputes.

Initialed and implemented health care benefits packages, maintained personnel records, prepared certified payroll and filed tax forms (940/941), reviewed tax exemption status with reference to accounts, responsible for purchasing and leasing equipment and processing worker’s compensation.

Addendum for Pharmaceutical / Medical Device Companies

My history within Clinical Research consists of supporting senior level executives such as V.P.’s, Medical Directors, Clinical Research Associates and Medical Practitioners conducting studies monitored by internal and external facilitators; which provide the case history for various developmental products in accordance to SOP’s and criteria of study. As the data is compiled by the different facilitators there could be adverse report (s) regarding patient reaction to the placebo or product. These reactions must be addressed within 24 hours to the facilitator as to how to proceed with this patient. Logging of adverse reactions is needed to depict patterns of abnormality to the study for review by the physicians.

Depending on the length of time (six months or five years), the data complied will provide the information needed in preparation for submission. The final study report will be written and reviewed prior to finalization into a virtual document for submission to the FDA.

Details regarding study reports procedural formatting:

Studies whether internally or externally are submitted for formatting normally as a Word document. There are presently several applications such as Predict, Wisdom, and Documentem; which use Word as a format standardized in preparation for FDA submittals. Normally consisting of table of contents with page references to different sections and possibly links (if virtual document), description of compound or protocol, date of study, authors of study, signature page, description of study (e.g. double blind, etc.); details of study which may include charts, tables and data.

General formatting consist of the following:

Receiving a study report and reviewing information to cut and paste correctly to the specific reference section (s).

Formatting may consist of modifying a document in font, sizing, appearance of chart or tables to fit within document page, page breaking, linking information from table of contents to reference material within a document, and any additional modification to appropriately complete. An example may be correcting a term defined by a medically dictionary for an iris is not gray but rather grey.

Details and inconsistencies such as the correct medical terminology for a grey iris (eye) must be reviewed prior to input.

After the document is completed and reviewed by the Medical Director of the study, it may be keep within a databank such as Wisdom or Predict. Of course each databank has different retention formatting such as system assigned file name possibly by product, code combination or compound file. Each system may have a specific guideline to upload, save, view, extract, and modify an existing file study, but this is determined by grant of authority (gatekeepers) and as to who may have even access to the program itself. Fortunately, limited access is used as a safeguard measure to secure the information.

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