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Pediatrician or FDA jobs in Columbus, OH, 43215

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Production Line Lead

KDC-Columbus  –  Groveport, OH
... Performs all work in a manner that is consistent with the company’s quality system and FDA good manufacturing practices, including maintaining a clean and orderly production area at all times. Follows, promotes and enforces safety and environmental ... - Apr 17

Medical Safety Reviewer

DivIHN Integration Inc  –  Columbus, OH, 43219
... - the investigation and reporting of medical product experiences, in-depth investigation of medical adverse events and works with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the FDA; ... - May 04

Scientific Writer Sr

Nationwide Children's Hospital  –  Columbus, OH, 43205
... This includes writing, editing, reviewing, analyzing, and providing guidance in preparation of concepts, protocols, protocol amendments, protocol consents, coordinating written responses to queries from the IRB, scientific review committees, FDA, ... - Apr 30

Medical Safety Reviewer

DivIHN Integration Inc  –  Columbus, OH, 43219
... - the investigation and reporting of medical product experiences, in-depth investigation of medical adverse events and works with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the FDA; ... - May 04

Post Doctoral Scientist - Gene Therapy/CRISPR/Stem Cell Biology

Nationwide Children's Hospital  –  Columbus, OH
... The NCH Center for Gene Therapy has a long track record of training leaders in gene therapy, has been the site of the development of the first FDA-approved AAV-mediated gene therapy for neuromuscular disease (SMA). Our lab is focused on the ... - Apr 30

Regulatory Affairs Intern

Americanregent  –  New Albany, OH
... Learn about the role of FDA in the drug development process for human and animal drugs. Gain hands-on experience in preparing regulatory documents for submission to the FDA. Learn about the different regulatory requirements for ANDAs, NDAs and NADAs ... - Apr 30

Associate Director, Manufacturing (GMP)

Amplifybio, LLC  –  New Albany, OH, 43054
... GMP Compliance: Oversee all manufacturing activities to ensure compliance with GMP regulations, FDA guidelines, and industry standards specific to cell and gene therapy. Adhere to robust quality systems, including batch record review, deviation ... - May 01

Electrical Control Engineer

ACL Digital  –  New Albany, OH, 43054
... Provide technical support in response to the FDA and other regulatory agencies. • Complete advanced maintenance activities or operate and monitor sophisticated plant support equipment in accordance with CFRs, cGMPs, SOPs, job plans and Amgen ... - Apr 17

Clinical Research Coordinator

Ohio State University  –  Columbus, OH, 43201
... supports activities to ensure compliance with all Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state and industry sponsor regulations; assists with coordinating and preparing for external quality assurance and ... - May 02

Quality Assurance Supervisor

Andelyn Biosciences  –  Columbus, OH, 43215
... Excellent detailed knowledge of cGMP, GLP, FDA guidelines Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change. Must be highly skilled in ... - Apr 10
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