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FDA jobs in Chicago, IL

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Director of Quality

Sibel Health  –  Chicago, IL
... With numerous FDA clearances and a recently completed fundraising round, we are poised for growth and expansion. We are seeking mission-driven individuals with a strong sense of purpose who believe that technology can improve the lives of our most ... - Apr 27

Clinical Research Site Director

M1 Health  –  Chicago, IL
... Regulatory compliance: Ensure that the research site is in compliance with applicable regulatory requirements, including institutional review board (IRB) approvals and FDA regulations. Staff management: Recruit the best research coordinators and ... - May 02

Senior Manager, Regulatory Affairs Advertising & Promotions

Xeris Pharmaceuticals, Inc.  –  Chicago, IL
... Leads the development and oversight of the processes and procedures relevant to the creation, review, and internal approval of FDA-approved prescribing information, Medication Guides, and patient labeling. Reviews external communications materials, ... - Apr 19

Assistant Director, Office of Research Integrity and Compliance

Ann & Robert H. Lurie Children's Hospital of  –  Chicago, IL
... Prepares routine reports to regulatory bodies and accrediting agencies (OHRP, ORI, FDA, etc.) for review and approval by the Director, Office of Research Integrity and Compliance and Sr. Vice President and COO of the Research Center. Essential Job ... - May 02

Clinical Research Coordinator III, Nephrology Research Program

Ann & Robert H. Lurie Children's Hospital of  –  Chicago, IL
... Adheres to research protocol in compliance with applicable institutional, local and federal regulations (OHRP, FDA, GCP, etc.). Functions as patient liaison for study questions, billing issues, etc. Maintains all study documents (regulatory binders, ... - Apr 26

Director, Engineering Verification and Release Management

Sibel Health  –  Chicago, IL
... With numerous FDA clearances and a recently completed fundraising round, we are poised for growth and expansion. We are seeking mission-driven individuals with a strong sense of purpose who believe that technology can improve the lives of our most ... - Apr 27

Senior Manager, Regulatory Affairs Advertising & Promotions

Xeris Pharmaceuticals  –  Chicago, IL, 60607
... Leads the development and oversight of the processes and procedures relevant to the creation, review, and internal approval of FDA-approved prescribing information, Medication Guides, and patient labeling. Reviews external communications materials, ... - Apr 19

Medical Science Liaison, Hematology/Oncology (Northern IL, WI)

TMAC's Direct Hire (Executive Search) Service  –  Chicago, IL
... They have received priority review from the FDA for two of their assets. They are looking for experienced MSLs who are working in the myeloma or lymphoma space. This is a can’t miss opportunity! Territories: Northern IL/WI Northern Cal/NV Pacific ... - Apr 10

Quality Manager

TH Daniels  –  Chicago, IL
... Take lead on all FDA / USDA matters. Qualifications You must have experience within the food and beverage industry, working in a manufacturing and quality environment. You must have a proven track record of leading teams of QA and Food Safety ... - Apr 26

Manufacturing Associate - Drug Substance

Medix  –  Chicago, IL, 60616
... Must comply with company policies, procedures (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement. Will be assigned to the daily operations, working with: Weighing and dispensing of material Filtration ... - Apr 05
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