Since 2006, J Brooks Consulting has strived to provide its clients with the highest quality service.

We work with each client to ensure that project objectives, requirements and timelines are met.

With an average of 20 years of experience in healthcare and medical product development, our staff are capable of providing a variety of consulting services.

about the founder

J Brooks Consulting was founded in 2006 by Jennifer Brooks.  Ms. Brooks began her career as a nurse in 1991 and has worked as a nurse in ambulatory, long-term, sub-acute, acute and critical care environments.  Her most recent nursing experience includes 14 years working in emergency and urgent care departments.  In these roles, she has been involved in department initiatives and committees and was often called upon to perform department audits in preparation for Joint Commission on Accreditation of Healthcare Organizations (JCAHO) inspections.  She also completed the Centers for Disease Control and Prevention (CDC) National Hospital Ambulatory Medical Survey.  Ms. Brooks recently earned both a bachelor of science in nursing and a master of science in nursing (family nurse practitioner; FNP) from Regis College as part of a three-year, full-time, acclerated program while continuing to work and run her business.  While at Regis, she was inducted into the Sigma Theta Tau nursing honor society. 

Her nursing experience has given her the unique ability to understand the impact of decisions made during the medical product development process.  Having witnessed product failures in a clinical setting, Ms. Brooks has seen the devastation that product defects can cause.  Using the principles of risk management, Ms. Brooks is able to carefully assess each situation and provide a reasonable solution for each problem, while maximizing product safety and minimizing the impact on the client's bottom line.

In parallel to her nursing career, Ms. Brooks earned a bachelor of science in toxicology from Northeastern University, where she graduated magna cum laude and received several honors including the Toxicology Faculty Award, the Dean Constatine N. Meriano Achievement Award in the Toxicology Program, the Bouvé College of Health Sciences Honors Program Distinction and the University Honors Program Distinction.  She was also inducted into the Phi Kappa Phi honor society.  Ms. Brooks then earned a master of science in drug regulatory affairs and health policy from the Massachusetts College of Pharmacy and Health Sciences. 

Ms. Brooks is a lifelong learner and participates in a variety of continuing education activities.  In 2004, she earned certification as a Certified Quality Auditor (CQA) from the American Society for Quality (ASQ) and Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS).  In addition to her academic achievements, Ms. Brooks has also received an entrepreneurship award and service awards from two employers.

While at Northeastern, she began working at Praecis Pharmaceuticals, where she started in the analytical chemistry laboratory developing methods to evaluate active pharmaceutical ingredients and drug products.  In this role, she also performed stability testing and performed experiments to characterize drugs and to optimize their manufacturing processes.  After a year in this role, she was offered opportunities to work in both the quality assurance and the pharmaceutical development groups.  For the next year, she worked jointly for both groups, eventually choosing to move into quality assurance.  While at Praecis, her career progressed with positions of increasing responsibility in the quality and regulatory organization and culminated in the position of Quality Assurance Manager.  She continued to gain experience implementing systems and performing audits to evaluate compliance to good manufacturing practice (GMP), good laboratory practice (GLP) and good clinical practice (GCP).  Working collaboratively with other departments, she implemented a competency system for evaluation of training, developed standard operating procedures (SOPs), developed and implemented a blood donation program, developed a digitial archiving system for laboratory notebooks, implemented an electronic document management system, assisted with technology transfers and monitored contract manufacturers.  She was also a member of the institutional animal care and use committee (IACUC) and worked with preclinical staff to achieve Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) accreditation. Because of her nursing background, she was relied upon to perform formulation experiments and to develop administration instructions for products in development.  In addition, she was involved in the submission of several regulatory documents including:  investigational new drug (IND) applications, a new drug application (NDA) and a marketing authorization application (MAA) in Germany.  Because Praecis was a small company, she gained experience in regulatory operations and regulatory writing. In addition to writing sections and performing quality control checks of regulatory submissions, she developed the risk management program for Plenaxis™ and designed and developed protocols for two Phase 4 studies. She was also the designated contact for Division of Drug Marketing, Advertising and Communication (DDMAC) during the approval process and worked with sales and marketing staff to obtain approval of marketing materials. She also participated in meetings with Food and Drug Administration (FDA) reviewers during the approval process.  Ms. Brooks left Praecis after seven years to join Aeris Therapeutics as Manager, Clinical Operations. 

At Aeris, she was the first clinical employee and was required to initiate the company's first Phase 1 study within 2 weeks of hire.  In this role, she was responsible for developing all clinical SOPs and clinical documents, developing and maintaining timelines and budgets and selecting and managing vendors that performed study-related activities.  She also wrote, assembled and submitted several clinical trial protocols/applications, including three in the United States, two in Europe, two in the Middle East and one in South America.  In this role, she had direct communication with regulatory agencies in several jurisdictions.  She was able to obtain fast-track designation for Aeris' lead product, a combination product that included a biologic (blood product), drug and device.  She brought data management activities in-house, saving the company approximately $1 million over about three years.  As part of this implementation, she designed the necessary information technology (IT) infrastructure, hired consultants to assist with the technical portion of the implementation and validated Oracle Clinical, Oracle TMS (thesaurus management system), SAS and eCTD (electronic common technical document) preparation and submission software.  Because Aeris was a small company, she often was called upon to assist other groups in the company with activities such as auditing manufacturers and assisting with the implementation of systems to ensure GLP compliance for preclinical studies.  After one year at Aeris, she was promoted to Associate Director, Clinical Research and Development.  After more than two years at Aeris, Ms. Brooks left and founded J Brooks Consulting. 

At J Brooks Consulting, Ms. Brooks has provided a variety of services.   She has been involved in a variety of projects ranging from relatively straightforward projects, such as writing SOPs, to very complex projects, such as implementing new systems.  She has performed over 100 audits and has reviewed and/or audited thousands of documents.  An experienced technical writer, she has been involved in the submission of several INDs and NDAs.  One client, an academic medical center, hired her to assist with the implementation of GMP systems to produce cultured autologous stem cells.  This project involved the development of associated procedures, execution of process qualification runs, development of master records and preparation of the IND.  The program was successful and the site was allowed to proceed with their clinical study.

In addition to her consulting activities, Ms. Brooks works part-time as Regulatory Affairs Manager at Microbiotix, where she is responsible for all product development activities.  In this role, she has also written many grants, some of which have resulted in large awards to Microbiotix.  She has run over 50 preclinical studies, overseen the manufacture of several drugs and obtained orphan designation for Microbiotix' lead product.  Ms. Brooks is also planning to work per diem as a nurse practitioner and is currently credentialing at a local hospital. 

Ms. Brooks has been involved with the development of many investigational drugs and commercial products.  She has worked with a variety of small molecules, biologics and devices in several therapeutic areas including:  oncology, pulmonology, neurology, infectious disease, dermatology and stem cell therapy.  Her experience spans from preclinical development through product launch and includes phase 1 through 4 clinical studies.  Ms. Brooks is a member of the American Society for Quality, the Regulatory Affairs Professionals Society, the American Society for Microbiology and the American Medical Writers Association.