Objective

Seasoned professional with diverse experience in ever-changing corporate environments, coupling my past experiences and background in seeking a challenging position utilizing my Office Coordinating abilities, and an extensive fund of Medical and Pharmaceutical knowledge and use it towards new challenging opportunities within an organization to advance my knowledge.

Dedicated and technically skilled business professional with a versatile administrative and managerial skill set developed through experience as a Director, Office Coordinator, Senior Consultant, and Administrative Assistant
Multi-dimensional, breakthrough thinking individual with an entrepreneurial perspective, possessing intuitive-visionary talent, expertise in performing diversified tasks, excellent communication skills and organizational skills
Charismatic, persuasive negotiator in building integrated marketing, business alliances and cross-branding partnerships, securing commitment and transforming presentations into closings
Successfully lead and motivate teams; advance performance and accountability. Create relationships through collaboration and open communication, navigating and coordinating dissimilar work styles into a mutual, productive entity that enjoys working together
Goal driven and dynamic team player with strong interpersonal skills; Dynamic leader who conceptualizes and absorbs information quickly; Enjoy accepting new tasks, projects, and challenges; Ability to adapt to all levels of personnel and specialize in customer satisfaction

Office Management,
Teambuilding & Supervision,
Staff Development & Training,
Data Entry, 68 wpm,
Records Management,

Report & Document Preparation,
Spreadsheet & Database Creation,
Office Inventory Management,
Internet,
Departmental Organization,

Microsoft Office (Outlook, Word, Excel, Lotus Notes, Publisher, PowerPoint, Visio, Soft Skill, Communicator, LiveMeeting, SharePoint)

Experience

Confidential,East Hanover, NJ

6-2011 to present

Compliance, Quality and Controls Project Manager/Coordinator

• Advanced assistance to the department by performing various complex administrative support functions, including but not limited to, analytical and specialized administrative duties to ensure efficient office operations
• Perform advanced Word Processing, Visio, Excel, PowerPoint, SharePoint, and Desktop Publishing support to include complex presentations, reports, spreadsheets and graphs; transcribes information of a technical, confidential and/or sensitive nature
• Handle highly confidential, sensitive and/or critical information, files, records and reports
• Oversee the scheduling and coordination of faculty meetings, conferences including travel arrangements, material preparation, facilities and catering needs, etc. Review day-to-day priorities and assignments and ensure consistent and compliant support for all departmental activities and services. Assume central identity for all departmental operational functions
• Resolve complex scheduling issues to accommodate multiple priorities across the spectrum of all directors and managers and adjust workloads for existing staff to accommodate peak work priorities
• QC all documents for consistency before obtaining final approvals
• Monitor Annual Review status to ensure completeness and manage Process monitoring
• Website Management
• Operational Assessments including Assist with the data analysis and test work documentation
• Develop and maintain databases to manage the centralization & archiving of all data files (both digitally and manually), reports/summaries and other support documentation
• Process optimization including coordinate with Functional area leads to ensure project tracking documents are current and accessible in SharePoint
• Act as recording secretary at project meetings; prepare action minutes as needed
• Align process optimization outputs with WPD activities
• Develop and maintain detailed administrative and procedural processes that reduce redundancy, improve accuracy and efficiency to achieve better organizational objectives

Confidential,Lawrenceville, NJ

1-2011 to 6/2011

Regulatory Operations Coordinator

• Provide support to Regulatory Affairs staff which includes both compliance and submissions functions
• Filing, tracking and logging serious adverse events (SAE) reports and checking for completeness and accuracy when necessary in the absence of pharmocovigilence personnel
• Assist with maintenance and filing of training records. Register for in-house training classes and assure that all training materials are prepared
• Assist with audit file maintenance including audit file setup, audit checklist preparation and filing of closed audit records/reports
• Maintenance of regulatory advisory committee files
• Preparation of copies of regulatory documents to be sent to Japan, the DSMB chairman & Iron Mountain
• Point of Contact for off-site archive of regulatory files at Iron Mountain; maintain logs and return of documents
• Travel arrangements for various groups in the company (Drug Development, Management, Global Business Alliance, etc.), prepare expense reports, arranges meetings, prepare meeting minutes, register staff for professional meetings, conduct internet searches, prepare and edit PowerPoint presentations & other administrative duties
• Iron Mountain Maintenance

Confidential,Cranbury, NJ

6/2010 – 12/2010

Secured Document Control Coordinator

• TMF auditing – scanning, preparation for NDA submission of AT1001, maintenance of records for Fabry, Gaucher, and Pompe’s disease
• TMF QC – 1572’s, IRB’s, Informed Consent, Investigator CV’s, Site documentation, Financial disclosures, monitoring report updating, IMP (Investigational Medicinal Product) accountability
• Training Files auditing – company spreadsheet formation, SOP documentation & training maintenance, Quality Control Checks
• CRF auditing – organization, QC of Case Books, preparation for Data Entry, QC of signature sheets and correct documentation, Assessments of patient documentation
• Secured document archiving management of TMF, CRF
• Quintiles SOP management and evaluation; Perform source documentation verification
• Created and maintained a centralized filing system for all project documents, manual and electronic by updating master filing index, electronic document files and folders in the project server
• Source documentation verification Served as executive assistant to the management team, handled a busy phone system, functioned as primary liaison to customers and ensured a consistently positive customer experience.
• In-house Clinical research Associate duties in training (assist in protocol development, CRF’s, finding facilities, setting up written guidelines for monitoring the various sites)

Confidential,Princeton, NJ

1/2010-6/2010

Office Manager

• Overall office management coordination with a large talent and management firm
• Assist candidates in executing workforce solutions that align talent strategy with business strategy
• Workshop creations – Record keeping – Confidentiality Procedures, Human Resources
• Assist Career Consultant in creating and implementing a talent management strategy to proactively develop, redeploy and transition employees to meet changing market and workforce needs
• Input of daily statistics, attendance, building career transition candidate relationships, conduct recruiting searches for workforce transition and outplacement

Confidential,Basking Ridge, NJ

5/2008-12/2008

Executive Administrative Assistant

• Travel Authorizations, Travel Vouchers, Employee reimbursement (local), Payroll, Rx upkeep, Mail, HR communication, Distributions, Tuition Reimbursement, Program forms, New employee folders, Meeting Bookings, Videoconferencing set up
• Check requests, Food ordering, Process CME evaluation forms, Confidentiality with employee documentation, i.e. Licenses, CEUs, etc..., Packing Slips, Dictations
• All necessary assignments and request from Hospital Administrator – including calendar organization, travel arrangements

Confidential,Melville, NY

11/2005-4/2008

Employee Relations Sales/Marketing Director

• Designed operations, provided strategic and tactical leadership, built a cohesive team, achieving ambitious penetration into targeted markets
• Directed employees in the marketing, promotion and direct sales of Quill (Office Supplies), Verizon (business to business and residential); Implemented training course for new recruits— speeding profitability
• Conducted direct cold-call selling visits, targeting local businesses. Gained face-to-face meetings with key decision makers; utilized effective sales tactics to achieve rapid closure. Advanced the sales and marketing effort by providing personalized service and building long-term relationships. Consistently followed-up; achieved customer loyalty and a high retention rate
• Daily operations of the business – recruiting, administration, overall operations and driving sales in a fast paced, high volume environment, led daily meetings with consultants to motivate and resolve any concerns, payroll – accounts payable, conference calls with various Fortune 500 company executives, extensive traveling, hiring and training, interviewing procedures daily, maintained inventory and territory
• Ensure successful training outcomes through applied instructional design and demonstrated proper training techniques to employees
• Networked within a competitive business arena; cultivating excellent contacts
• Supervised the direct marketing of telecommunication services of Verizon and Verizon FIOS to companies and individuals
• Traveled extensively to New York and New Jersey and meet with clients for account reviews

Confidential,

4/2003-11/2005

Clinical Office Manager

• Directed patient care, EKG, phlebotomy, immunizations, allergy injections, office safety, Quest and LabCorp connections, pharmaceutical preauthorization’s, sterile techniques (instrument and procedures), assisting in procedures (colposcopy, skin removals, vasectomy, etc.)
• Coding, front office management, billing, scheduling appointments, medical records, dictations, ordering and stocking medical supplies, responsible for clinical aspect of office

Confidential,Easton, PA

6/2002-4/2003

Senior Health Information Manager

• Responsible for conducting emergency room, outpatient and short procedure operations analyses, filing
• Front office management, phones, hospital running, transcription review

Confidential,Belle Mead, NJ

1/2000-11/2001

Mental Health Technician

• Direct patient care, vital signs, psychological assessments, patient charting for various units, i.e. geriatric, acute care, adolescent, & addiction/abuse
• Assisted psychiatrist and nurses with analysis of patients and daily activities

Education

A.S. – Biological Science and Mathematics
B.S. – Labor Studies & Employee Relations