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Job Title: Director, Pharma Forensic
Job Location: NY: New York
Pay Rate: Open
Job Length: full time
Start Date: 2008-09-14

Company Name: KPMG
Contact: Recruiter
Phone: email only please
Fax: email only please

Description: Business Title: Director, Pharma Forensic Requisition Number: 19249 Function: Advisory Area of Interest: Forensic Investigations State: New York City: New York Description: KPMG LLP is a leader in providing audit and advisory services to the public sector, and more specifically, to the federal government. KPMG has long viewed the public sector as an industry in which we do more than just participate - we choose to set an example as a leader - as evidenced by our relationships and experiences with many federal agencies. The Advisory Services team strives to help the federal government improve on both regulatory demands and their strategic approach to performance a nd risk management. Advisory professionals are able to provide relevant industry and functional skills where they need them most. We are currently seeking a Director to join us in our New York City office focused on the Pharmaceutical industry. KPMG ForensicSM uses computer forensic and data analysis techniques to help our clients detect fraudulent activity and other forms of misconduct. In addition, KPMG LLP, the U.S. member firm, operates the Cypress Technology Center (CTEC), which offers sophisticated technology tools and skilled professionals to help clients reduce litigation costs and risks in the areas of evidence and discovery management and the acquisition, management, and analysis of large data sets. Responsibilities: . Assist organizations with compliance program assessment, implementation, and monitoring related to clinical research and pharmaceuticals . Provide pre and post-submission regulatory control, clinical research, clinical monitoring experience for large, complex protocols and/or programs . Maintain working knowledge of technologies supporting clinical development and successful product registration with the FDA . Interview clients and assess external sources for the purpose of effectively obtaining and analyzing relevant information . Design, prepare, and deliver analysis reports and findings . Develop and sustain solid relationships with client personnel and identify opportunities to provide additional services . Assist in assembling, managing, training, and administering team Qualifications: . Ten years of experience managing large, complex clinical trials for pharmaceutical companies and/or providing advisory services to this industry . Knowledge of clinical trial process, including any of the following: study start-up, site selection, patient recruitment, or study termination activities . Experience in clinical development, clinical trial design, protocol development, managing the writing of clinical sections of regulatory submissions, or management of industry-sponsored clinical trials . Understanding of drug development process, SOPs, GXP and applicable regulations, and designated therapeutic/clinical systems . Experience with FDA regulatory submissions, FDA inspections, management, preparation, response, and 483s . Bachelors degree from an accredited college/university . Able to participate in moderate to extensive level of travel KPMG offers and supports flexible work arrangements as well as part-time schedules. We also offer a comprehensive compensation and benefits package. Interested? We strongly encourage you to apply online at www.kpmgcareers.com and search for requisition 19249 or click the job link below. If you are interested in this, and other opportunities within KPMG, please attend The KPMG World Jobs Fair at http://events.unisfair.com/index.jsp• eid=298&seid=29&code=kpmgjobl . It starts at 9am GMT on Wednesday, September 24and closes at 9am GMT on Friday, September 26. Find out what time this is in your part of the world by clicking going to http://www.timeanddate.com/. KPMG. A great place to build your career. No phone calls or agencies please. KPMG Affirmative Action, Equal Opportunity Employer, M/F/D/V. KPMG maintains a drug-free workplace. - 2008 KPMG LLP, a U.S. limited liability partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International, a Swiss cooperative. All rights reserved. GL: 3 GF: 15295

Please refer to Job code kpmg-19249 when responding to this ad.

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