About J Brooks Consulting
J Brooks Consulting was founded by Jennifer Brooks. Ms. Brooks has over 13 years
of industry experience and over 20 years of clinical nursing experience. In industry,
she has worked on projects involving drugs, biologics, devices and combination
products.
Ms. Brooks has earned the following academic degrees:
- Bachelor of Science in Toxicology
- Bachelor of Science in Nursing
- Master of Science in Drug Regulatory Affairs and Health Policy
- Master of Science in Nursing, Family Nurse Practitioner (FNP)
Ms. Brooks holds the following certifications:
- Regulatory Affairs Certification (RAC) from the Regulatory Affairs
Professionals Society (RAPS)
- Certified Quality Auditor (CQA) from the American Society for Quality (ASQ)
- Nurse Practitioner from the American Academy of Nurse Practitioners
(AANP)
Nursing experience:
- Acute and critical care: 14 years in emergency and urgent care departments
- Sub-acute and long-term care: 6 years in nursing home, sub-acute care units
and temporary agency providing staffing to a variety of facilities
- Obtained data and consent from patients for academic research studies
- Prepared for Joint Commission on Accreditation of Healthcare Organizations
(JCAHO) and Department of Public Health (DPH) inspections
Industry experience:
- Quality Assurance/Regulatory Affairs
- Audited/Reviewed Thousands of Documents
- Performed over 100 Audits in the United States, Canada and Europe
- Preclinical contract research organizations
- Bioanalytical vendors
- Raw material vendors
- Active pharmaceutical ingredient (API)/drug substance
manufacturers
- Intermediate manufacturers
- Drug product manufacturers
- Packaging, labeling and distribution vendors
- Analytical laboratories
- Clinical research organizations (operations, data
management)
- Phase I clinical trial units
- Clinical sites
- Clinical laboratories
- Document storage facilities
- Software vendors
- Implemented Systems/Programs
- SOPs/Quality Systems
- Archives
- Blood Donation Program
- eCTD submission system
- Provided Training
- Prepared Regulatory Submissions (preclinical, CMC and clinical; in
traditional and CTD formats)
- United States
- Europe
- Central America
- Israel
- Operations (Preclinical, Manufacturing, Clinical)
- Designed and Conducted/Oversaw over 50 Preclinical Studies
- Caco-2 permeability
- hERG
- Cytochrome P450 induction and inhibition
- Genetic toxicology
- Safety pharmacology
- Subacute and acute toxicity
- Bioanalytical method development and validation
- Dose formulation analysis method development and validation
- Manufacturing (experience with peptides and small molecules in a project
management-type role)
- Oversaw process scale-up and manufacturing of APIs and drug
products
- Coordinated physicochemical characterization and release testing
of APIs and drug products
- Oversaw validation of analytical methods
- Selected and managed formulation development vendors
- Assisted with the design of a GMP facility
- Started a clinical organization in a small company
- Wrote approximately 20 clinical trial protocols
- Wrote several Investigator’s Brochures
- Prepared informed consent forms
- Coordinated translation of clinical documents
- Designed and produced case report forms
- Managed clinical trials in the United States, Europe and Israel
- Selected clinical research organizations (CROs), clinical trial
sites and clinical laboratories
- Data Management/Statistics
- Implemented and validated Oracle Clinical, Oracle TMS and
SAS Enterprise Business Intelligence Server; designed IT
infrastructure to support implementation
- Set up data management systems in a company where there
was no data management function
- Performed data rescue on a study that had been poorly
managed
- Developed global library, edit checks and manual checks
- Performed data validation
- Utilized MedDRA and WHO-DD dictionaries
- Project Management
- Grant Writing
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