Duration : 12+ Months Contract with possible extension
Location : Collegeville, PA 19426
Title : Global Innovative Products Clinical Quality Control Reviewer
The candidate will review and modify submission-ready clinical documents by demonstrating high attention to detail, in order to guarantee quality of the final document.
The ability to work independently to think through results, resolve data discrepancies, be able to comb through long data ...
Nature and Scope
The Regulatory Associate provides administrative support to the Clinical Regulatory group. He/She is responsible for the organization and compilation of the regulatory submissions and maintains the regulatory files to ensure that dossiers are easily retrieved for review by the team. He/She works with pharmacovigilance to process and file Pharmacovigilance reports to the FDA in a timely manner.
Organization and retention of controlled documents, tracking ...
The general supervisor will be responsible for the day to day operation under the direct supervision of the Laboratory Director. This person will monitor the daily performance of the laboratory through the stated quality control and quality assurance programs; perform and ensure that all corrective or remedial action is taken if the laboratory control deviates from the laboratory's stated quality control policy before any patient test results are reported. They will be responsible for the sample ...
MANAGER is Looking for a Quality Documentation background. -----
We are looking for candidates with solid experience in quality review of pharmacovigilance documents and reports submitted to regulators. GMP, GCP and GLP experience is not helpful." The candidate must have experience in a pharmaceutical environment with a strong background in Quality.
The candidate should also have Extensive experience with filing and auditing -----
Job description: ----- In this role the candidate will Conduct QC ...
Mar 13 -
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