Karen L. Rauen
New York,New York
Summary
Knowledgeable director with proven background in consulting, delivering strategic insights and effective solutions to clients. Successfully led multiple projects, enhancing operational efficiency and driving business growth. Demonstrated expertise in problem-solving and client relationship management.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Expert Consultant, Consumer Product Testing and Regulation
Karen Rauen Ph.D. Consulting
01.2021 - Current
- Provide industry and category knowledge and technical expertise to clients regarding the safety, efficacy, testing, quality and industry / regulatory requirements for consumer products in cosmetics, personal care, and household sectors
Clinical Investigator, Cosmetics and Hygiene
SGS North America, Inc.
12.2022 - 09.2024
- Oversaw the execution of the clinical research studies of consumer products involving paid participants according to good clinical practices (GCP), FDA regulations, SOPs and protocols
- Spearheaded the efficacy testing program as Principal Investigator in Elizabeth NJ location and Site Investigator in the Union NJ location
- Developed, maintained and reviewed Standard Operating Procedures (SOPs)
- Ensured that study personnel had access and were trained to SOPs and that SOPs are followed to ensure high quality
- Interfaced with the Sponsor, staff, contractors, professional societies, Institutional / Investigational Review Board (IRB), subjects, government agents / agencies and other business units as required
- Obtained appropriate information, documentation and signatures
- Protected the rights, safety and welfare of subjects
Senior Technical Manager, Cosmetics and Hygiene; Program Manager, Clinical Studies
SGS North America, Inc.
09.2021 - 12.2022
- Project Management of complex and / or long-term studies (equipment acquisition and setup, human resource recruitment/training, process planning, execution, reporting)
- Responsible for technical support, regulatory compliance and testing program development for the cosmetics, personal care and household product categories
- Developed an internal and external network of testing labs to support the test programs
- Supported responses to tenders and/or projects from a technical perspective
- Served as Program Manager or Principal Investigator for complex or long-term clinical trials, with a primary focus on efficacy testing in SGS’s New Jersey test facilities
- Built a structured matrix tool to facilitate more efficient, effective development of retail test plans
- Provided technical support to sales teams, account managers and clients to support laboratory operations
- Actively participated in interactions with clients, with a special focus on developing test programs for retail and big box store accounts
- Collaborated with sales team and global technical teams to support responses to new client opportunities and engage in client inquiries
- Prepared and supported the preparation of test plans, test protocols and/or SOPs according to regulatory and/or client requirements
- Executed ingredient and product label reviews in accordance with applicable US/Canada regulations
- Supported the development and execution of sensory and consumer panel testing plans
- Contributed to SGS presentations and online content via Digicomply regarding North American regulations (e.g., Modernization of Cosmetics Regulation Act of 2022, Per- and polyfluoroalkyl substances) applicable to cosmetics, personal care and household products sectors
Senior Director, Clinical Evaluations; Principal Investigator
Consumer Product Testing Company, Inc.
04.2019 - 05.2021
- Served as Principal Investigator and primary contact with clients for clinical trials in Clinical, and Special Studies, for activities such as, but not limited to: project management, structure and scheduling of trials, Institutional Review Board approvals, oral and written communications, hosting, monitoring, and inspections, and for support and follow-up activities
- Ensured the overall regulatory and quality compliance of the clinical operation with GCP, GMP, GLP, DEA, EPA, OSHA, and other local, State, and Federal guidelines and regulations
- Developed and reviewed protocols for bioinstrumentation studies and clinical trials consistent with Good Clinical Practices, local, State and Federal laws and regulations
- Reviewed and approved protocols in Photobiology, Clinical, and Special Studies for consistency, completeness, accuracy, and compliance with individual client requirements
- Provided guidance and assistance in protocol implementation and interpretation of results for bioinstrumentation studies and clinical trials
- Advised clients and senior management with regard to clinical, scientific, and business issues
- Assisted the Sales Department in promoting testing services
- Liaised with Administration and the Quality Assurance Unit in the development and maintenance of all Standard Operating Procedures (SOPs) for the laboratory
- Administered the training program in the clinic including the planning, conducting, and documenting of all training sessions
Principal Investigator and Operations Director
SGS North America, Inc.
11.2017 - 04.2019
- Conducted and / or supervised studies in accordance with protocols, Standard Operating Procedures, and applicable FDA / Governmental / International regulations
- Interfaced with the Sponsor, staff, contractors, professional societies, Institutional Review Board, subjects, government agents / agencies and other business units
- Ensure that all individuals working on the study have necessary credentials, are adequately trained, understand their obligations and are properly supervised
- Maintain training records of staff members
- Obtained appropriate information, documentation and signatures
- Protected the rights, safety and welfare of subjects
- Ensure that the Informed Consent is clear and accurate and correctly administered
- Wrote protocols, collected and reviewed data, prepared progress reports, analyzed results, wrote summaries and conclusions and issued reports
- Maintained and reviewed Standard Operating Procedures (SOPs)
- Ensured that study personnel have access to Standard Operating Procedures and that they are followed
- Communicated with Sponsors and Institutional Review Boards regarding protocols and any Adverse Events
- Maintained a safe and hygienic facility
- Monitored Quality Assurance (QA)
- Maintained accurate and complete records
- Assured confidentiality of records
Technical Director, Cosmetics, Personal Care and Household; Manager, Detergents
SGS North America, Inc.
11.2014 - 07.2018
- Provided technical knowledge, test solutions, and regulatory guidance to customers and internal technical teams in the cosmetics, personal care, and household segments
- Managed test projects across a global network of testing laboratories
- Played a key role in the development of retailer testing programs for the US division of Cosmetics, Personal Care and Household, which generated millions of dollars in revenue over the years
- Developed protocols to address regulatory requirements and packaging and performance testing demands
- Directed, monitored and managed the testing for cosmetics, personal care and household sectors
- Ran the Detergents laboratory
- Developed strategic management initiatives across profit centers to help support and grow the business both locally and globally
- Provided global technical support
- Utilized strong technical knowledge, experience and communication skills to educate and advise clients and provide guidance to technical profit centers
- Oversaw the development of test protocols and procedures for all categories, using standard methods or, when standard methods were unavailable, developed internal test methods to help substantiate claims
- Performed label and ingredient reviews for cosmetics and personal care
- Provided claims review
- Investigated new capabilities, and qualified and secured contracts with laboratories for possible subcontract work or acquisition
- Created and edited educational publications regarding new technical or regulatory issues for internal and external distribution
Director, Health and Consumer Sciences Operation
Consumer Reports
07.2007 - 06.2013
- Directed testing and reporting of consumer products in foods, dietary supplements, cosmetics, personal care, fitness, and medical devices
- Managed the Sensory department and Analytical laboratory
- Utilized strong communication and editing skills to generate, copy edit, and fact check editorial content
- Supervised 15 direct reports including chemists, engineers, food scientists, and public health professionals
- Managed a testing budget of $1 million+, accommodating additional projects while remaining at or under budget
- Proven ability for defining test objectives and priorities for operational efficiency
- Procured and contracted independent laboratories, medical and technical professionals
- Directed studies at clinical, chemical, physical and microbiological testing labs
- Oversaw the development of test protocols and procedures for all categories, using standard methods or, when standard methods were unavailable or industry-proprietary, developed internal test methods
- Edited copy and managed the presentation of test findings in all media products and documentation
Education
Ph.D. - Chemistry
University of Cincinnati
Cincinnati, OHBachelor of Science - Chemistry
Northern Kentucky University
Highland Heights, KYSkills
- Problem-solving
- Attention to detail
- Team leadership & development
- Client relationships
- Consumer Product Testing
- Regulatory Compliance
- Method Development
- Protocol Design
- Clinical Research
- Technical Documentation
- US FDA, GXP Regulations
- Client Management
- Process Planning
- Product, Label Reviews
- Presentation Skills
- Data Analysis
- Collaboration Skills
- Project Management
- People Management
- Critical Thinking
Affiliations
- American Chemical Society (ACS)
- American Society of Testing and Materials International (ASTM)
- The Association of Clinical Research Professionals (ACRP)
- Cosmetic Executive Women (CEW)
- International Association of Women (IAW)
- Society of Cosmetic Chemists (SCC)
Certification
Certificate Principal Investigator (CPI), The Association of Clinical Research Professionals
Timeline
Clinical Investigator, Cosmetics and Hygiene
SGS North America, Inc.
12.2022 - 09.2024
Senior Technical Manager, Cosmetics and Hygiene; Program Manager, Clinical Studies
SGS North America, Inc.
09.2021 - 12.2022
Expert Consultant, Consumer Product Testing and Regulation
Karen Rauen Ph.D. Consulting
01.2021 - Current
Senior Director, Clinical Evaluations; Principal Investigator
Consumer Product Testing Company, Inc.
04.2019 - 05.2021
Principal Investigator and Operations Director
SGS North America, Inc.
11.2017 - 04.2019
Technical Director, Cosmetics, Personal Care and Household; Manager, Detergents
SGS North America, Inc.
11.2014 - 07.2018
Director, Health and Consumer Sciences Operation
Consumer Reports
07.2007 - 06.2013
Certificate Principal Investigator (CPI), The Association of Clinical Research Professionals
Ph.D. - Chemistry
University of Cincinnati
Bachelor of Science - Chemistry
Northern Kentucky University
Similar Profiles
Asal AbdolhosseiniAsal Abdolhosseini
Digital Marketing Specialist at Karen Lab / Karen Poya NoavarDigital Marketing Specialist at Karen Lab / Karen Poya Noavar
Ziheng ShanZiheng Shan
Intern at Sophia Koutsogiannaki, Ph.D.Intern at Sophia Koutsogiannaki, Ph.D.
Ericka N. Negrón ColladoEricka N. Negrón Collado
Undergraduate Student Researcher at Rafael Montalvo Rodríguez, Ph.DUndergraduate Student Researcher at Rafael Montalvo Rodríguez, Ph.D