
jennifer head
regulatory affairs project manager
About
Regulatory Affairs Consultant with background in pharmaceuticals and medical devices. Focus primarily on submission and maintenance of CNS drug products and controlled substances. Experienced in CE Marking and 510K submission for pharmacogenetic assays as well as pharmaceutical related pre-IND and pre-NDA activities, IND and NDA submission, life cycle maintenance and MAA submission. ASCP certified generalist medical laboratory scientist with 3 years of clinical and Lean Six Sigma experience. Technical background in clinical microbiology, virology, microarray assay development, vaccine candidate development, high-throughput assay design involving cell culture, biochemical, immunofluorescence, and molecular approaches.
united states
san marcos
pharmaceuticals
microbiology, molecular biology, cell culture, virology, pcr, immunology, flow cytometry, rt pcr, cell biology, immunofluorescence, microsoft office, pharmaceutical industry, regulatory affairs, u.s. food and drug administration, project management, consulting, life cycle management, vaccines, microsoft excel, regulatory intelligence, new drug application, united states pharmaceutical regulatory affairs, investigational new drugs, controlled substance
Experience

research associate
the scripps research institute
* Identification and development of new drug therapies to combat human pathogenic arenaviruses. * Design and optimization of cell based assays to identify molecules to be used in identification of potential novel targets and antiviral drugs to combat human pathogenic arenaviruses. * Assessment of identified inhibiting molecules on LCMV replication/transcription via minigenome assay * Assessment of identified inhibiting molecules on LCMV entry and budding * Completed work on T32 Postdoctoral NIH grant and the 2015 Kempner Postdoctoral Fellowship

graduate assistant
utmb
* Identification of antiviral targets for Rift Valley fever virus in addition to characterization of innate immune response against several Rift Valley fever vaccine candidates. * Characterized the function of major virulence factor NSs protein of Rift Valley fever virus (RVFV) * Characterization of RVFV infection in human dendritic cells. * Development of a dominant negative strategy for inhibition of RVFV NSs protein. * Characterization of NSs filament formation and its effect on NSs functions.

medical laboratory scientist
texas children's hospital
* Team member of the clinical microbiology and serology departments within general pathology. * Performed biochemical and visual identification of medically significant microbes in patient samples * Prepared plates, gram stains, and slants for diagnostic analysis * Recorded and entered workup and results for patient samples * Member of Lean Six Sigma team responsible for redesigning the general pathology area for microbiology setup and shipping departments. * Wrote and managed implementation of new protocols for microbiology/serology and shipping departments while working along- side upper level management and department employees

regulatory affairs project manager
bachem

senior associate consultant
parexel
PAREXEL International Corporation is a leading global biopharmaceutical services organization, providing a broad range of expertise-based contract research, consulting, medical communications, and technology solutions and services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. PAREXEL Informatics, Inc. provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in 82 locations in 51 countries around the world, and had approximately 18,660 employees in the fourth quarter.Visit www.PAREXEL.com for more information.

research scientist
autogenomics
* Research and design of microarray assays for use in pharmacogenomics and microbial identification in clinical specimens. Assays are applied to the INFINITI system unique for Autogenomics' proprietary BioFilmChip microarrays. * Specialization in Women's Health and pharmacogenomic analysis for various chemotherapy treatments. * BSL2 design and laboratory safety regulations. * Management of CE-Mark certification on assays I manage as lead scientist. * Guidance and mentoring of graduate students and student interns. * Safety Officer for R&D Chemistry

consultant
parexel
* Pre-IND pre-NDA, IND, NDA submission and life cycle maintenance activities for CNS pharmaceuticals, controlled substances, new molecular entities and new chemical entities. * Initiation and relay of FDA communications (including face to face meetings with the Agency and CSS). * Drafting of protocols and company document templates. * Regulatory intelligence, competitive intelligence and benchmark research. * Project management (maintaining and completing tasks for multiple projects (including budget) in a timely manner to customer satisfaction). * US CPP applications and legalization (eCATS). * Preparation of MAA and MAT submission packages and Manufacturing Site Name Change submission packages (EU). * Basic US Cosmetic claim analysis. * Microsoft Office, ISIWriter and LIQUENT document formatting and drafting. * GEPIC, ORIOM and CREDO experience. * QC of various documents for publication and submission.
Education
skyline high school
texas a&m university - corpus christi
biology
the university of texas medical branch
microbiology
jennifer head's Contact Information
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