v********a 发帖数: 646 | 1 The scientist or engineer will serve as the pharmacology/toxicology expert
on a multidisciplinary review team that typically consists of product,
clinical, and pharmacology/toxicology reviewers. Their primary
responsibility will be the evaluation of preclinical data (e.g., in vitro
and animal studies) during premarket review of investigational products. The
pharmacology/toxicology reviewer provides feedback to sponsors regarding
the design of their preclinical development program prior to investigational
submissions. Additionally, they will review the preclinical data in
investigational regulatory submissions to determine if there is adequate
support for the rationale and safety of product administration in the
proposed clinical population. The reviewer is also responsible for the
review of the nonclinical sections of Biologics License Applications (BLAs)
and Premarket Approval (PMA) applications. The regulatory reviews require
written analyses and recommendations, as well as verbal communication of
recommendations. Presentation at various scientific meetings is also an
important aspect of the position.
The FDA offers:
Excellent Federal Government Benefits Package (e.g., health insurance, life
insurance, and retirement savings plan)
Flexible Work Schedules, including the opportunity for telework
Professional development opportunities and paid travel expenses to national
professional meetings
Qualifications:
The Pharmacology/Toxicology Branches in the Division of Clinical Evaluation
and Pharmacology/ Toxicology in the Office of Tissues and Advanced Therapies
in the Center for Biologics Evaluation and Research (CBER/OTAT; Silver
Spring, Maryland) are searching for outstanding scientists and biomedical
engineers with training and/or experience in pharmacological, toxicological,
biological, and/or veterinary sciences to join our team of Scientific
Reviewers. Involvement in research projects investigating tissue-engineered,
stem cell therapy, and/or gene therapy products, and experience conducting
experiments in animals is beneficial.
To Apply:
If you are interested, please e-mail a copy of your curriculum vitae with a
cover letter to
Mercedes Serabian at mercedes.serabian # fda.hhs.gov. | p**********h 发帖数: 1 | 2 谢谢分享,请问需要公民或绿卡吗?
The
investigational
【在 v********a 的大作中提到】 : The scientist or engineer will serve as the pharmacology/toxicology expert : on a multidisciplinary review team that typically consists of product, : clinical, and pharmacology/toxicology reviewers. Their primary : responsibility will be the evaluation of preclinical data (e.g., in vitro : and animal studies) during premarket review of investigational products. The : pharmacology/toxicology reviewer provides feedback to sponsors regarding : the design of their preclinical development program prior to investigational : submissions. Additionally, they will review the preclinical data in : investigational regulatory submissions to determine if there is adequate : support for the rationale and safety of product administration in the
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