1. Deborah A. Hardgrove
714 Magnolia Lane
Branchburg, NJ
(Mobile) 908-963-5031
debmmkk@yahoo.com
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Synopsis: Ambitious professional with more than 25+ years experience in the
Pharmaceutical and Consumer industries. Excellent organizational skills.
Demonstrated strengths in leadership, customer service, sales, data
management, project management, and communications. Ability to interact
with all levels of management. Complete understanding of regulated
environment. (FDA, State Regulatory bodies).
Professional Experience:
Novo Nordisk, Inc. Princeton, NJ 2010-Present
Sr. Administrator Medical Affairs/ FMA Strategy Operations
• Performs a wide range of administrative and business support duties for 12
Medical Directors, as well as for Sr. Director Medical Strategy & Operations.
• Duties include calendaring in MS Outlook, meeting/conference set-up, domestic
& international travel coordination, and expense reports
• Interacts with internal and external vendors and sources at the executive level,
planning and preparing meetings
• Promotional Review Board (PRB) Coordination of Medical Directors schedules
and coverage
• Coordinates special projects and department activities, assists in the planning and
execution of FMA Mid year and End year National training meetings for 200
people.
Business Support Coordinator 2009-2010
• Support Clinical Trials
• Study Start up (Regulatory Documents) & Maintenance of Clinical Trial Files
• Responsible to send FQ & CDA & process fully executed CDAs
• Process IND Safety Reports for all the studies
• Maintain CTU Tracker for the CDAs and Safety Reports
• Upload IEC/IRB list in NovoDocs for 1842 & AERx studies
• Archive & code Regulatory documents
• Serve as back-up as requested
• Assist in training and development with new hires
Johnson & Johnson GCO Trial Management Bridgewater, NJ 2007-2009
CTA (Clinical Trial Assistant) (Contractor)
Project Support for LTM’S (Local Trial Managers)
• Assist LTM’S in the process in accordance with SOPs incoming Serious Adverse Event
(SAE) forms, including site follow-up for resolution of data queries, assist in the

2. distribution of IND Safety Letters to investigators and tracking of necessary Follow-up
Report, as appropriate.
• Assures completion of required clinical trial documents within Central Files (i.e., CVs,
FDA 1572, Lab Certification, Financial Disclosure and IRB, etc.) throughout the clinical
trial.
• Maintenance of project specific regulatory documents inventory systems.
• Maintenance of clinical trial monitoring/management tracking systems.
• Work with project team to assure successful completion of a trial in accordance with
current federal regulations and SOPs.
• Set-up, populate and maintain the clinical trial monitoring/management tracking
systems.
Hreshko Consulting Group. N.Brunswick, N.J. (2004-2007)
Executive Search Consultant
Processed over 25,000 potential candidates annually. Full recruitment cycle management
including: sourcing, screening interviews, reference checks, assessments, and qualifications
processing of potential candidates. Client base included 1 National account with 30 state
offices as well as 10 locally based companies.
 Project Management duties for all employees.
 Engaging in routine and complex document preparation, file
management, scheduling/arranging meetings, and ordering office
supplies.
 Electronic filing of all office documents.
 Effectively communicated project status with hiring managers and senior
executives throughout each engagement ensuring full client satisfaction.
 Responsible for annual business development ($180K) and maintaining current
relationships on an ongoing basis.
 Provided critical candidate selection advice to hiring mangers, HR
managers, and senior management.
 Maintained daily communications with clients and candidates.
 Conducted salary negotiation, counter offer counseling culminating in closing
candidate on behalf of clients.
 Maintained accurate and detailed files as per State Regulatory Compliance.
 Trained new associates in the recruitment and administrative process.
 Recommended and implemented improvements to the recruiting
screening process resulting in better candidate selection.
 Developed detailed Job descriptions that helped define roles and
responsibilities for each position.
Johnson & Johnson RWJ Research and Development Raritan, N.J. (1988-2004)
Senior Clinical Data Specialist
Served as departmental representative on cross-functional clinical project teams as part of
clinical trials for new drugs.
 Interacted with external groups, contract research organizations (CRO)
and external data supplier staff, for project plan execution and data query
resolution.
 Trained CROs to perform on each clinical trial.
 Recommended and monitored vendor timeliness.
 Maintained accurate project documentation per FDA requirements.

3.  Developed, implemented and maintained clinical trials processing and
reporting databases to established standards with minimal guidance.
 Technical expertise in data management, selected as team tester and
trainer for new systems for internal staff, contractors, external data
vendors, and CROs.
 Participated in implementation of new technologies.
 Contributed to data management process improvements as well investigator
meetings and study site visits.
 Reviewed draft Case Record Forms/protocols and approved final drafts.
 Entered changes/updates to the database from Data Clarification Forms.
Weight Watchers International. 2000 – Present (Part-Time)
Leader/ Mentor
Based on exceptional results over 10 years, selected to pilot first Weight Watchers full
time Leadership Program in the nation. Motivational speaker at 18 weekly meetings
throughout Central NJ, with a member base of 400. Ranked “Powerhouse Leader” for
extraordinary meeting attendance records.
 Plan, deliver weekly educational sessions to members on the Weight Watchers
program and products available for member purchase. Consistently rated in “Top
5” Diamond Leader status for member retention, % member reaching goal, most
members losing 100+ pounds, and member lifetime achievements.
 Selected to supervise, coach, and develop assigned apprentice leaders, guide them and
ensure they meet weekly meeting objectives on a consistent basis.
 Sell Weight Watchers memberships, products, and promotional items.
 Provide assistance and guidance so that members feel cared for, part of the group,
motivated and informed while attending Weight Watcher meetings.
 Accountable for member satisfaction; caring, efficient & informative customer service;
professional representation to the public; processing joining and current members;
recording and reconciliation of sales and receipts; and maintenance of member files.
 Awarded on member retention and members achieving their desired outcome.
 Currently presents in 4 weekly meetings
Education
Raritan Valley Community College 1979 – 1981
Skills
Powerpoint, Excel, Word, Microsoft Access and other populated software packages.