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Job Title: GCP Specialist
Job Location: NY: Bronx
Pay Rate: Open
Job Length: full time
Start Date: 2008-08-27

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

Description: GCP Specialist Tracking Code 2006842 Job Description The Clinical practices specialist provides quality and good clinical / good laboratory practice (GCP/GLP) support to Clinical Affairs, Regulatory Affairs, and Quality Assurance for products in development. The scope of oversight is clinical trials and all related processes and procedures. Support includes auditing and performance management of Contract Research Organizations (CROs) including Bio-Analytical laboratories as well as clinical site preparation for FDA site audits.

Specifically, this position will review and provide feedback on clinical study protocols for compliance to applicable regulation as well as create and issue audit plans for the audits conducted at Contract Research Organizations (including facilities, personnel, equipment, and SOPs). This position will coordinate with Pharmaceutical Development QA/GMP to strengthen and review systems and facilities within Perrigo that are associated with the shipment, inventory return, inventory and destruction of Investigational Drug Products. The incumbent will communicate and coordinate with Pharmacovigalance in collection and reporting of serious adverse events from clinical trials in compliance with applicable regulatory requirements. This position fulfils the role of study monitor when required and provides support for clinical data integrity for new regulatory filings. This position will also be responsible for the quality training of Regulatory and Clinical Affairs and Quality personnel, specifically in the area of Good Clinical Practices. Additional responsibilities include database management, creating assessment reports for management review, and developing metrics to monitor CRO performance.

This position will be located at the Perrigo New York facility. Required Skills The incumbent must possess substantial knowledge of Clinical Trial Methodologies, Good Clinical Practice, Good Lab Practices, as well as clinical packaging and blinding techniques. Practical experience with GCP, ICH and FDA regulations are required. Excellent analytical skills and the ability to interpret and apply ICH / FDA regulations to company operating procedures are necessary. Excellent communication skills are essential, including well developed interpersonal skills, the ability to work effectively with staff members at all levels, strong technical writing skills and computer literacy. The incumbent must have project management skills with the ability to handle many projects simultaneously. A minimum of bachelor degree in a Biomedical or scientific discipline is required in addition to at least 5 years of prior professional experience in Clinical Affairs within a pharmaceutical development environment or a CRO. Job Location Bronx, NY, US. Position Type Full-Time/Regular

Please refer to Job code perrigo-259431 when responding to this ad.

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