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Scientific Program Manager

Axle  –  Rockville, MD
... Minimum of seven (7) years experience as an Auditor Lead conducting reviews and audits of regulatory and clinical trial documents (trial master file documents) as related to ICH E6 guidelines, GxP, and applicable FDA regulation. Knowledge of GxP ... - Jun 05

FLEX WORKERS PROGRAM- Warehouse Technicians

Granules  –  Manassas, VA, 20109
... experience required Inventory Count experience required Manufacturing: 2 years (Preferred) cGMP environment: 2 years (Preferred) FDA and OSHA regulations: 2 years (Preferred) Experience with SAP (Preferred) Physical Requirements/Working Environment ... - Jun 10

SAFETY & PHARMACOVIGILENCE SPECIALIST

Beacon Hill Life Sciences - Boston  –  Bethesda, MD
... research including: adverse event analysis and processing, serious adverse event reconciliation • Preparation of IND safety reports for submission to the FDA • Safety document or data analysis • Clinical trial site support REQUIREMENTS • M.D. ... - Jun 02

Clinical Research Nurse

MAPMG  –  Flower Hill, MD, 20879
... review, and informed consent documents Obtain and prepare regulatory documents required to conduct clinical trials, including: investigator CVs, financial disclosure forms, laboratory certifications, radiation safety exemptions, FDA 1572 forms, etc. ... - Jun 07

Clinical Manager, Organ Recovery (Nurse, RN, Nurse Leadership) - PACU

Infinite Legacy  –  West Falls Church, VA, 22042
... Accountable for organ recovery staff adherence to all regulatory and accrediting agency standards, including, but not limited to CMS, UNOS, AOPO, FDA and AATB, as well as all internal Infinite Legacy organizational policies, procedures, and ... - Jun 17

PKI Administrator Tier III

Peraton  –  Rockville, MD, 20850
... This qualified individual will join our FDA Program's high performing team. What you will do: * Will resolve daily PKI and Smart card access tickets which includes user permissions, SSL certificate request, servers and applications access requests * ... - Jun 18

Medical Officer

ACI Federal  –  Bethesda, MD, 20811
... Individuals providing this expertise will be named as reviewer of information relevant to the safety of the drug in question, on line 15 and 16 of the IND application (FDA Form 1571). Evaluate annual IND annual reports for medical safety and report ... - Jun 21

Project Manager

Ukpeagvik Inupiat Corporation  –  Springfield, VA, 22156
Overview PROJECT MANAGER (FDA): Bowhead seeks a Project Manager to support the HHS - FDA Consolidated IT Helpdesk Service contract located in Springfield, VA. This effort will support services providing the full range of technical support, project ... - Jun 06

PKI Administrator Tier III

Peraton  –  Rockville, MD
... This qualified individual will join our FDA Program's high performing team. What you will do: Will resolve daily PKI and Smart card access tickets which includes user permissions, SSL certificate request, servers and applications access requests ... - Jun 15

Manufacturing Associate I/II - Cell Culture

MacroGenics  –  Rockville, MD, 20850
... with exposure to science and math coursework and a minimum of two years of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment OR Associate’s degree with one year of related biopharmaceutical ... - Jun 05
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