FOLA RAE

Edison, NJ

732-***-****

acqj8a@r.postjobfree.com

SUMMARY OF SKILLS

Skilled at evaluating and streamlining business processes to write SOPs.

Experience interfacing with cross-functional teams to gather information for reports.

Able to review project goals and resources to delegate responsibilities.

Mastery of Microsoft Office programs (Word, Excel).

WORK EXPERIENCE

Merck & Co., Inc., Regulatory Affairs Operations, Rahway, New Jersey

Project Manager II, February 2012 - June 2013; February 2014 - August 2014 Collaborated with eDiscovery and Records Management department to oversee all aspects of archiving FDA and internal correspondence; performed and re-engineered procedures to draft and continuously update Standard Operating Procedures (SOPs); reviewed Merck records retention and destruction schedules and procedures and incorporated into project SOPs; trained project team to implement changes in procedures; evaluated project effort, cost and support to manage transfer and maintenance of records within storage facilities; responded to customer requests for records by conducting research, retrieving physical records, and providing electronic or hard copies to requestors; created records management storage and indexing solutions.

General Services Administration, Office of Governmentwide Policy, Washington, D.C. Writer-Editor, April 2009 – January 2012

Interviewed Subject Matter Experts and staff members to document and formalize SOPs for the Office of Acquisition Policy; managed gathering, compiling, writing and editing information to draft plans in response to guidance from Office of Management and Budget (OMB) and Office of Federal Procurement Policy (OFPP) including the GSA Open Government Plan, the GSA Acquisition Human Capital Plan and the GSA Acquisition Career Management Handbook; drafted and edited various agency publications including comprehensive reports, acquisition letters, memoranda, web content, brochures, pamphlets, and handbooks.

Waldman & Diamond, Chartered, Kensington, Maryland

Law Clerk, September 2008 – April 2009

Drafted outgoing correspondence and demand letters to clients and insurance companies for personal injury cases; contacted hospitals, physicians, and physical therapy offices to request records of medical diagnosis and treatment; prepared pleadings, interrogatories, requests for answers to interrogatories, and requests for production of documents; served copies of discovery documents; attended meetings with clients to discuss client wishes for preparation of wills and trusts; filed court documents at Maryland, and Washington, D.C. courthouses.

Department of Health & Human Services, Administration on Developmental Disabilities, Washington, D.C.

Fall Extern, September 2008 – December 2008

Reviewed Notice of Proposed Rulemaking (NPRM) and public comments for Developmental Disabilities Assistance and Bill of Rights Act (DD Act) to ensure compliance with statute; reviewed all public comments and considered validity and impact of comments if adapted, and whether proposed changes would alter purpose of statute; compiled final comprehensive report with recommendations to agency based on proposed changes from review of public comments and analysis of existing law.

Foster, Swift, Collins & Smith, P.C., Attorneys, Lansing, Michigan

Library Assistant, March 2006 – August 2008

Communicated with attorneys and paralegals in person, by e-mail, and by telephone, to assist with legal research and recommend additional library resource materials; routed publications to practice group areas manually and electronically; processed inter-library loan requests for other branches of law firm; communicated with vendors to resolve account problems; filed looseleaf services, advance sheets, periodicals, and supplements in appropriate binders; reviewed shelves for missing or misplaced books, removed out of date materials, and restocked shelves; updated “pocket-parts” and other publications in need of revisions, corrections, or updates; maintained master log of library materials.

DLEG, Michigan Commission on Disability Concerns, Lansing, Michigan

Summer Extern, May 2008 – August 2008

Represented Michigan Department of Labor and Economic Growth (DLEG) at meetings with other State agencies to discuss statewide program objectives for persons with disabilities; surveyed sites with architects to document proposed changes to state owned buildings and facilities to comply with requirements of Section 504 of the Rehabilitation Act; contacted clients by telephone to discuss and document disability complaints and prepared written responses to clients; prepared legal memorandum to challenge denial of disabled veteran’s application for property tax exemption; prepared for Michigan Youth Leadership Forum.

Thomas E. Brennan Law Library, Lansing, Michigan

Circulation Assistant, January 2005 – August 2006

Assisted students with electronic and manual legal research; checked out, checked in, and renewed circulating library materials, including course reserves; shelf reading of book stacks to ensure books shelved in correct order; gathered books and shelved by call number and returned reference materials to circulation desk; completed inter-library loan requests by photocopying articles from books or by using machine reader to find and print articles from microfiche and microfilm; monitored student and guest access to law library.

Law Offices of David M. Sternfield, Esq., Chicago, Illinois

Autism Legislation Project, Volunteer West Coast Team Leader, September 2004 – January 2005 Researched existing state legislation on autism and developmental disabilities; compiled research and submitted to law office electronically; supervised 14 interns by conducting orientation fornewteammembers and communicating regularly by telephone and email to expedite research; managed group website and database; participated in bi-weekly conference calls with law office.

YMCA of Metropolitan Lansing, Lansing, Michigan

Assistant to Executive Director, January 2004 – April 2006

Wrote speeches for executive director presentation at non-profit sector events; drafted short and long bios to appear in local publications; prepared agenda and packets for monthly executive board meetings; planned and organized annual volunteer appreciation dinners; edited outgoing correspondence and sorted incoming correspondence; prepared excel spreadsheets for invoices and entered data; researched grant opportunities and drafted proposals; placed calls and worked on call center teams for various fundraising efforts; prepared signage for special events.

Schering Plough Research Institute, Kenilworth, New Jersey

Worldwide Regulatory Affairs Assistant, August 1999 – August 2003

Compiled and submitted domestic New Drug Applications (NDA) and Investigational New Drug (IND) applications and amendments to the Food and Drug Administration (FDA); drafted correspondence to the FDA at direction of managers; published drug filing registration international dossiers and submitted to health authorities and pharmaceutical governing bodies worldwide; edited and proofread patient information sheets and patient medication guides for drug packaging; drafted Standard Operating Procedures (SOPs) for regulatory affairs daily operations; created links and bookmarks within documents to adhere to regulatory affairs publishing guidelines.

EDUCATION

Thomas M. Cooley Law School, Juris Doctor with Administrative Law Concentration

Rutgers University, Bachelor of Arts in English

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