We're looking for a Project Manager I - Periodic Reporting Quality, working in the Pharmaceuticals & Medical Products industry in Bridgewater, New Jersey, United States.
Reviews Annual Reports (AR), Annual Report amendments, Periodic Adverse Drug Events Reports (PADER), and other required regulatory documents.
Provides support for preparation of Regulatory reports without creating conflict of interest and reviews all reports not prepared by the PRQ PM for accuracy, completeness, and compliance to established SOPs, Federal Guidelines and Regulations
Tracks and analyzes identified errors to determine root causes and to recommend remediation strategies aimed at reducing error rates and provides back-up support in the generation of the specified regulatory documents
Provides highest level quality assurance of AR /AR Amendment/PADER documents and assistance in execution of the process for generating these documents.
The pay range we're offering is 40 - 49 per hour. This position may present an opportunity to go permanent.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years’ experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
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.
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.