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Job Title: Director, Regulatory Affairs and Compliance
Job Location: NY: New York City
Pay Rate: Open
Job Length: full time
Start Date: 2007-05-08

Company Name: The Cambridge Group Ltd.
Contact: Stephanie Oscar
Phone: E-mail or fax only
Fax: 203-226-3856

Description: Director, Regulatory Affairs and Compliance



Northeastern medical research foundation is currently searching for a seasoned Regulatory Affairs/Compliance professional for their main office in New York City. Incumbent will be responsible for regulatory oversight including responsibility for regulatory programs relating to over 35 ongoing clinical studies and development of strong Standard Operating Procedures/Operating and Quality Manuals for Data Coordinating Center to include the US and OUS regulatory requirements relating to: study start-up; clinical site selection; protocol development; Case Report Form development; database selection, programming and documentation; database validation; data collection and cleaning; data analysis and report generation; conduct of Clinical Events Committees, Data Safety Monitoring Boards, Scientific Steering Committees and Clinical Investigation Meetings. In addition, you will: serve as regulatory resource to staff during all phases of clinical study management, be responsible for current knowledge of US/OUS clinical regulatory requirements; represent Data Coordinating Center Regulatory function during visits from study sponsors; serve as main liaison with these entities in their clinical programs; perform business development/marketing function as applies to regulatory systems and processes; with the Quality Assurance Department, plan for and administer all clinical regulatory vendor (Sponsor) and regulatory authority (FDA/BIMO or other) audits; author IDE (and possibly IDE) submissions for FDA and assist outside contractors in the development of OUS submissions to Ethics Committees and Competent Authorities; develop and administer staff training programs in regulatory compliance, including all aspects of FDA and ICH clinical trial requirements; and assist in due diligence and qualification efforts in the selection of vendors to provide clinical services. The ideal candidate will have a degree in natural sciences and an advanced degree is preferred. Formal training (and preferred certification