Ruth Ann Groff (Kearns)
Beattyville,USA
Summary
In-depth knowledge of investigational and marketed drug product development/life-cycle management. Results-driven management professional with proven ability to lead teams to success. Strong focus on team collaboration, operational efficiency, and achieving measurable outcomes. Adept at strategic planning, process improvement, and fostering culture of accountability and excellence. Known for adaptability and consistently meeting changing organizational needs.
Overview
33
33
years of professional experience
Work History
Manager, Submission Management
Janssen Research & Development, L.L.C.
10.2022 - 05.2025
- Project Management/lead team to establish Dossier Plans and tracked submission timelines.
- Maintained submission calendars to meet company timelines
- Ensured dispatch/distribution was in compliance with Health Authorities and/or Local Operating Company regulations / requirements
- Develop departmental work practices, process enhancements / improvements, and associated training materials. Trained / mentored new employees to current J&J standards
- Cultivates ongoing effective relationships across GRA as well as cross functionally. Maintains open communications with key partners to ensure priority conflicts, resource issues, and deviations from the plan are identified and resolved
- Monitored and ensured adherence to evolving regulatory guidelines, including ICH, FDA, EMA, and local regulations
- Telephone (908) 203-4090
Lead Associate, Submission Management
Janssen Research & Development, L.L.C.
10.2015 - 10.2022
- Management and delivery of regulatory submissions to global health authorities
- Established Dossier Plans for the assigned submission types
- Ensured relevant submission process(es) are applied to all assigned submissions
- Monitored the effectiveness of appropriate submission processes with responsibility for initiating changes within the scope of decision-making authority to minimize inefficiencies and ensure quality
- Ensured dispatch/distribution in compliance with due dates to Health Authorities and/or Local Operating Companies
- Supported development of departmental work practices, process enhancements, and associated training materials
- Telephone (908) 203-4090
Senior Associate, Regulatory Affairs
McNeil Consumer Healthcare
06.2011 - 10.2015
- Dossier lead/submission manager on new IND/sNDA applications (including McNeil and Janssen cross sector project)
- Coordinate/Publish submissions (including annual reports, protocol amendments, CMC amendments, etc...) using eCTD standards
- Participated on IND/NDA application teams to support eCTD requirements
- Trained employees on eCTD template authoring standards
- Trained reviewers and publishers on DocuBridge Publishing/Viewer Software
- Telephone (215) 273-7000
Coordinator/Publisher, Regulatory Affairs
Smith Hanley Consultant assigned at sanofi-aventis
09.2009 - 06.2011
- Coordinated all maintenance items (including annual reports for IND and OD products, protocol amendments, CMC amendments, safety reports, etc...)
- Assisted with IND and NDA original applications (eCTD format)
- Coordinated briefing documents for meetings with FDA, amendments, supplements, responses to requests from health authorities
- Maintenance as required for IND applications
- Published submissions using eCTD standards
- Telephone (800) 684-9921
Associate Manager, Regulatory Affairs (Combination Product)
Ikaria Inc.
08.2008 - 07.2009
- Managed worldwide labeling (including development of core data sheet through labeling approval and labeling updates)
- Provided tactical support to Regulatory Project Leaders and Project Teams
- Managed/wrote all maintenance items (including annual reports for IND, NDA and OD products, protocol amendments, CMC amendments, safety reports, etc...)
- Assisted with coordination of 510(k), IDE
- Managed CRO for Canadian/Australian CTAs
- Prepared briefing documents for meetings with FDA, amendments, supplements, responses to requests from health authorities
- Maintenance as required for IND and NDA applications
- Telephone (908) 238-6600
Senior Associate, Regulatory Affairs (Oncology and Pain therapeutic divisions)
Cephalon, Inc.
01.2004 - 08.2008
- Provided tactical support to Regulatory Project Leaders and Project Teams
- Managed/wrote all maintenance items (including annual reports for IND, NDA and OD products, protocol amendments, safety reports, CMC Amendments, etc...)
- Coordination/management of IND and NDA (eCTD) original applications
- Managed CRO submissions for foreign applications (Canada, Australia and Germany)
- Reviewed/managed marketing material for NDA products (including two product launches)
- Managed product labeling (core data sheets through approval and updates as required)
- Prepared briefing documents for meetings with FDA, amendments, supplements, responses to requests from the FDA, as well as ongoing file maintenance as required for IND and NDA applications
- Telephone (610) 344-0200
Assistant/Coordinator, Regulatory Affairs
Cephalon, Inc.
01.2002 - 01.2004
- Supported/coordinated Regulatory team to provide submissions (CMC and Clinical) to FDA (including compiling, book marking and hyper-linking)
- Reviewed/processed Safety Reports
- Reviewed promotional/labeling pieces
- Reviewed/processed new investigators and revised 1572 forms
- Authorized clinical supply to sites
- Managed travel arrangements/Meeting schedule
Non-Conformance/Calibration Administrator
Micro-Coax, Inc.
09.1999 - 08.2001
- Managed non-conformance reports
- Monitored preventative and corrective actions
- Maintained ISO 9002 requirements
- Performed internal audits
- Arranged/performed calibrations of equipment used for final measurements
- Organized calibration certification logs
- Telephone (610) 495-0110
ORP Course Coordinator
Synthes, USA
10.1997 - 09.1999
- Coordinated all administrative details for Spine & Maxillofacial ORP courses
- Organized hotel contracts
- Developed floor plans, managed set-up of A.V. equipment, banquet menus
- Developed budgets and maintained financial records
- Interacted with outside vendors: printers, travel agency, faculty gift selection
- Documented/maintain American Nurses Credentialing Center’s accreditation files
- Telephone (610) 647-9700
Quality Control, Manufacturing
Wyeth-Ayerst Labs
03.1994 - 03.1997
- Monitored batch mixes for quality control
- Statistical Control Committee (member): Trained Continuous Improvement Teams on obtaining information and utilization of charts and graphs with their projects and presentations
- Continuous Improvement Team (sponsor): Overlooked a team with the project of improving quality and increasing production on the liquid penicillin line
- Continuous Improvement Team (team member): Improved throughput time and decreased lost product on the NOACK birth-control packaging line
- Telephone (610) 644-8000
Senior Clerk- Hospital Sales Regional Office
Wyeth-Ayerst Labs
02.1992 - 03.1994
- Assisted field consultants with daily transactions/general office functions
- Revised/monitored marketing statistic reports
- Planned sales conferences/training seminars
- Arranged travel schedules
Education
Commonwealth Diploma Program - GED Received
Pennsylvania Department of Education
(some credits obtained)
Immaculata University
Immaculata, PA01.2010
Skills
- Project management
- Cross-functional teamwork
- Policy implementation
- Product management
- Coaching and mentoring
- Policy and procedure development
- Change management
- Regulatory compliance
- Process improvement
- Customer service
Timeline
Manager, Submission Management
Janssen Research & Development, L.L.C.
10.2022 - 05.2025
Lead Associate, Submission Management
Janssen Research & Development, L.L.C.
10.2015 - 10.2022
Senior Associate, Regulatory Affairs
McNeil Consumer Healthcare
06.2011 - 10.2015
Coordinator/Publisher, Regulatory Affairs
Smith Hanley Consultant assigned at sanofi-aventis
09.2009 - 06.2011
Associate Manager, Regulatory Affairs (Combination Product)
Ikaria Inc.
08.2008 - 07.2009
Senior Associate, Regulatory Affairs (Oncology and Pain therapeutic divisions)
Cephalon, Inc.
01.2004 - 08.2008
Assistant/Coordinator, Regulatory Affairs
Cephalon, Inc.
01.2002 - 01.2004
Non-Conformance/Calibration Administrator
Micro-Coax, Inc.
09.1999 - 08.2001
ORP Course Coordinator
Synthes, USA
10.1997 - 09.1999
Quality Control, Manufacturing
Wyeth-Ayerst Labs
03.1994 - 03.1997
Senior Clerk- Hospital Sales Regional Office
Wyeth-Ayerst Labs
02.1992 - 03.1994
(some credits obtained)
Immaculata University
Commonwealth Diploma Program - GED Received
Pennsylvania Department of Education