The Periodic Reporting Quality Project Manager (PRC PM) will be expected to review Annual Reports (AR), Annual Report amendments, Periodic Adverse Drug Events Reports (PADER), and other required regulatory documents. This person will also provide support for preparation of Regulatory reports without creating conflict of interest
Review all reports not prepared by the PRQ PM 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; the candidate will be fully knowledgeable of the process
Provide highest level quality assurance of AR /AR Amendment/PADER documents and assistance in execution of the process for generating these documents. This role includes quality assessment of both the regulatory documents and the process to ensure the following:
- that all studies are appropriately classified for inclusion/exclusion
- that all reportable studies sponsored by client are included in the report
- that comments in the spreadsheet are accurate
- that study synopses for completed clinical studies meet the established standards
- validation of all documentation for the ARs and/or amendments, e.g., NDA (New Drug Application), PADER (Periodic Adverse Drug Experience Report), and PMA (Pre-Market Approval) for submission to the FDA.
Bachelor’s Degree in Life Science or related field, preferred.
Extensive experience in peer/quality review of annual reports.
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, and the ability to work with databases, sharepoints, and clinicaltrials.gov, etc. in an electronic environment. .
Other required skills and attributes:
-Demonstrated superb organizational, time management and communication skills (verbal and written)
– Demonstrated experience working on multiple projects simultaneously
– Strong interpersonal skills with the ability to interact with all levels of the organization
– Strong problem-solving, follow-through and decision-making skills for assigned projects with minimal supervision
– Proven ability to work both independently and in a team setting, and to meet goals by managing timelines
Source: Job Diva – Job Listing