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Welcome to this web site and thank you for taking the time to learn more about the
company.
Areas of Expertise
About J Brooks Consulting
J Brooks Consulting was founded by Jennifer Brooks. Ms. Brooks has over 10
years of industry experience and over 15 years of clinical nursing experience. In
industry, she has worked on projects involving drugs, biologics, devices and
combination products.
Ms. Brooks earned a Bachelor of Science in Toxicology and a Master of Science in
Drug Regulatory Affairs and Health Policy. She holds the following certifications:
Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals
Society (RAPS) and Certified Quality Auditor (CQA) from the American Society for
Quality (ASQ).
In industry, Ms. Brooks has held positions in the Quality Assurance, Regulatory
Affairs, Clinical Research and Development and Pharmaceutical Development
departments. Ms. Brooks is currently licensed as a nurse and works per diem in a
hospital setting. As a nurse, Ms. Brooks has worked in critical, acute, sub-acute,
ambulatory and long-term care settings. She currently holds certifications in
Advanced Cardiac Life Support (ACLS) and Pediatric Advanced Life Support
(PALS).
Summary of Experience
company.
Areas of Expertise
About J Brooks Consulting
J Brooks Consulting was founded by Jennifer Brooks. Ms. Brooks has over 10
years of industry experience and over 15 years of clinical nursing experience. In
industry, she has worked on projects involving drugs, biologics, devices and
combination products.
Ms. Brooks earned a Bachelor of Science in Toxicology and a Master of Science in
Drug Regulatory Affairs and Health Policy. She holds the following certifications:
Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals
Society (RAPS) and Certified Quality Auditor (CQA) from the American Society for
Quality (ASQ).
In industry, Ms. Brooks has held positions in the Quality Assurance, Regulatory
Affairs, Clinical Research and Development and Pharmaceutical Development
departments. Ms. Brooks is currently licensed as a nurse and works per diem in a
hospital setting. As a nurse, Ms. Brooks has worked in critical, acute, sub-acute,
ambulatory and long-term care settings. She currently holds certifications in
Advanced Cardiac Life Support (ACLS) and Pediatric Advanced Life Support
(PALS).
Summary of Experience
- Authored sections/entire submissions for Investigational New Drug
Applications (INDs), New Drug Applications (NDAs), Marketing Authorization
Applications (MAAs) and Investigational Medicinal Product Dossiers (IMPDs) - Provided submissions in Common Technical Document (CTD) and electronic
CTD (eCTD) formats - Wrote, reviewed and edited preclinical, clinical, manufacturing and regulatory
documents; wrote Investigator's Brochures, clinical protocols, toxicology
protocols and chemistry, manufacturing and controls (CMC) documents - Audited facilities, documents and processes for Good Manufacturing Practice
(GMP), Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
compliance - Experienced with clinical and regulatory processes and requirements in the
United States, Europe (pre- and post-Clinical Trial Directive), the Middle East
and South America - Involved in development activities from the pre-IND to post-marketing stages
- Monitored clinical sites and managed contract research organizations (CROs)
- Oversaw implementation and validation of data management, statistics and
regulatory systems including IT infrastructure - Prepared for Joint Commission on Accreditation of Healthcare Organizations
(JCAHO) and Department of Public Health (DPH) inspections
- Regulatory Affairs
- Quality Assurance
- Clinical Research
- Product Development
Serving the Pharmaceutical, Biotechnology,
Medical Device and Health Care Industries
Medical Device and Health Care Industries
| Copyright © 2006-2007 J Brooks Consulting |
