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Periodic Reporting Quality Project Manager

New Jersey All, NJ

Posted: 06/17/2019 Job Type: Clinical Job Number: JN -062019-25085

Review Annual Reports, Annual Report Amendments, Periodic Adverse Drug Events Reports, and other required regulatory documents

Review all reports for accuracy, completeness, and compliance to established SOPs, Federal Guidelines and Regulations

Track and analyze identified errors to determine root causes and to recommend remediation strategies aimed at reducing error rates

Provide back-up support in the generation of the specified regulatory documents

Provide highest level quality assurance of AR /AR Amendment/PADER documents and assistance in execution of the process for generating these documents

Requirements:

Degree

Extensive experience in peer/quality review of Annual Reports within a pharmaceutical/biotech/CRO company

Exceptional project management, including managing multiple complex projects from start to completion

Demonstrated involvement in cross-functional teams and capabilities in planning, initiation, executing, and reporting activities

Demonstrated functional knowledge of Good Clinical Practices, Corporate policies and standard operating procedures as well as knowledge of applicable external regulatory requirements and guidelines

Extensive knowledge of the regulatory requirements for various periodic reports, including knowledge of pharmaceutical clinical trial process and AR documentation requirements

Ability to work under tight timelines and excellent attention to detail is essential

Strong skills in Excel, SharePoint, EDC, etc.

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