Stephanie Faucheux
West Chester,OH
Summary
Proactive Manager with extensive experience in implementing new processes and driving innovations. Known for exceptional active listening, problem-solving, and a diverse professional skill set, combined with comprehensive knowledge of policies and procedures. Skilled in assessing and improving client and employee capabilities and managing key projects.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Regulatory Submissions Manager
Medpace
Cincinnati, OH
05.2023 - 03.2024
- Managed global start-up processes, including health authority submissions, e-CTD documentation and budget/contract negotiation progress from study start to trial completion, according to Sponsor and Medpace specifications
- Prepared and quality-checked e-CTD submissions, start-up, and amendment documents for CTAs, NDAs, INDs, and other local applications, ensuring compliance with internal and external requirements
- Provided regulatory submissions advice, and guidance to adhere to established deliverables and ensure quality compliance with appropriate regulations and requirements i.e ICH, GCP, Medpace SOP’s
- Developed proactive solutions to operational challenges, aligning with relevant government and institutional guidelines- serving as the main liaison for sponsors and internal project teams
- Facilitated collaborations with Sponsors, medical facilities, academic institutions, Institutional Review Boards (IRBs)/Ethics Committees (ECs, US and ex-US government regulatory authorities, and Medpace team
- Presented in bid defenses, project kick-off meetings, general weekly capabilities meetings, and audits with all levels (C-suite members)
- Oversaw 24 Regulatory Submissions Coordinators, 15 Contract/Budget Specialists, and 6 Clinical Trial Assistants while managing the success metrics for the start-up processes of 10 simultaneous trials in different phases
Regulatory Submissions Coordinator
Medpace
Cincinnati, OH
01.2019 - 05.2023
- Reviewed, approved, distributed and tracked individual site trial master file (TMF) essential documentation at project start and through life of trial
- Collected, reviewed, organized, and assembled regulatory (e-CTD) submissions documents while communicating directly with US/CAN IRB’s, EC’s, and internal team members
- Negotiated, drafted, and reviewed trial documents and site-specific Informed Consent Forms, while also analyzing regulations and guides to develop proactive solutions for clinical trial submission issues
- Established and facilitated timelines for study start-up (including all subsequent submissions) and contributed insights into start-up strategies
- Simultaneously led diverse teams in attaining regulatory compliance, streamlining processes, and enhancing documentation through effective guidance
- Trained and mentored CRAs and RSCs on essential document management for project start-up and ongoing amendments throughout the maintenance phase
Operations Manager (Coach)
Nike
Cincinnati, OH
03.2017 - 09.2018
- Maintained operational database for 80+ personnel
- Facilitated individual team members' professional development
- Tracked achievement of performance metrics, inventory KPIs, and store initiatives
- Supervised day-to-day workflow of employees in order to maximize productivity and maintain quality standards
- Recruited, hired, and trained new personnel on company mission and processes
Operations Lead (Athlete)
Nike
Monroe, OH
03.2015 - 03.2017
- Managed and tracked inventory via database analysis
- Reviewed, evaluated and interviewed prospective new hires
- Conducted onboarding and training of new hires
- Managed community service partnerships and programming against established objectives
- Collaborating with other departments such as apparel, footwear, equipment, and stockroom to ensure smooth cross-functional operations
Marketing / Customer Care Representative
RetireMed
Springboro, OH
04.2014 - 12.2014
- Assisted the Vice President of Marketing and Business Development in the creation and distribution of marketing collateral
- Contributed to and executed process improvement initiatives for customer experience while managing front-end customer service involvement
- Planned and executed live marketing events in support of Business Development
Education
Bachelor of Science - Biological And Biomedical Studies
University Of Cincinnati
Cincinnati, OH12-2017
Skills
- ICF Draft/Review
- EDMS/RIMS- Other Propriety Platforms for: project management, data input, e-CTD submissions
- GCP/ICH Regulations
- FDA/IND Clinical Trials Compliance
- IBC's: Advarra, WCGIRB, Local IBC's
- IRB/EC's: Advarra, WCGIRB, Sterling, Health Canada, EMA (CTR), Local IRB's (Includes ex-US Regulatory Agencies)
- Microsoft Office
- Adobe Acrobat
- Project and Performance Management
- Contract & Budget Control
- Team Leadership
- Time Management
- Verbal and written communications
- Key Performance Indicators
- Workforce Management
Certification
Good Clinical Practice Certification
Volunteer
- Community Ambassador - Nike Inc. (Affiliated with: Evanston Academy, Big Brothers Big Sisters, Beyond Exercise Fitness, Richard E. Lindner YMCA)
- Chiari Cares, Event Coordinator – Cincinnati Children’s Hospital Medical Center
References
References available upon request.
Timeline
Regulatory Submissions Manager
Medpace
05.2023 - 03.2024
Regulatory Submissions Coordinator
Medpace
01.2019 - 05.2023
Operations Manager (Coach)
Nike
03.2017 - 09.2018
Operations Lead (Athlete)
Nike
03.2015 - 03.2017
Marketing / Customer Care Representative
RetireMed
04.2014 - 12.2014
Bachelor of Science - Biological And Biomedical Studies
University Of Cincinnati
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