Jennifer Romaine
Operations Research Analyst, Office of Business Informatics, Strategic Programs, CDER at FDA
- Role
- Operations Research Analyst, Office of Business Informatics, Strategic Programs, Cder at FDA
- Location
- Silver Spring, MD, US
- LinkedIn followers
- 500 followers
About Jennifer Romaine
Results-driven product owner and program manager with over 15 years of diversified…
Experience
Operations Research Analyst, Office of Business Informatics, Strategic Programs, Cder
Jun 2017 — Present
Product Manager (Technical Delivery), Division of Data Management Services and Solutions (Feb 2022 – Present)CDEROne Product Owner: Managed 75+ contractor resources across multiple projects while achieving 11-12% reporting efficiency improvements saving 240-250 hours per user annually through safety dashboardsChange Management: Delivered comprehensive training programs conducting 64+ sessions for 1,226 users across CDER offices with 95% completion rate and 70% improvement in user capabilitiesTechnical Manager: Drove $20M cost savings by leading legacy report transition converting 58 reports into 20 CDEROne replacements impacting 1,600+ users across CDER including OND, OGD, and OPQ teammatesProduct Manager (Implementation) supporting CDER/OPQ, Division of Drug Quality, Compliance Services & Solutions (June 2017 – Feb 2022)• Project Manager - Leading technology solutions for 1,200+ Office of Pharmaceutical Quality (OPQ) users across regulatory review programs, improving efficiency in quality reviews and inspection management through the CDER Informatics Platform• Product Manager - Developing Quality Metrics systems, managing QMIS projects, and leading agile development teams to deliver user-focused technology solutions for pharmaceutical regulatory operations• Process Improvement & Data Analytics - Conducting quantitative analyses for Congressional reporting requirements, optimizing facility catalogs with data elements, and implementing COVID-19 impact tracking systems• Stakeholder Engagement & Training - Establishing relationships with office leadership and industry partners while providing helpdesk support, user training, and technical guidance across complex regulatory systems• Technical Expert & Contract Officer Representative - Managing multi-disciplinary teams of FTEs and contractors while serving as Contract Officer Representative for $6.5M+ technology contracts supporting drug quality capabilities
Education
St. Mary's College of Maryland
Bachelors of Arts
2002 — 2006
University of Maryland - Robert H. Smith School of Business
MBA
2010 — 2013
Bethesda-Chevy Chase High School
International Baccalaureate Diploma
Skills
- Analytical Skills
- Clinical Development
- Analysis
- Research
- Change Management
- Adobe Creative Suite
- Spss
- Cross-Functional Team Leadership
- Research Project Management
- Ctms
- Business Process Improvement
- Protocol
- Compliance
- Biotechnology
- Innovation Management
- Leadership
- Regulatory Compliance
- Data Analysis
- Lifesciences
- Clinical Trial Management
- Clinical Trials
- Project Management
- Microsoft Office
- Life Sciences
- Microsoft Excel
- Training
- Immunology
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