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FDA BIMO Inspections and Compliance Consultant
MEDVACON
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Washington, DC, 20022
... Position Overview Medvacon Life Sciences is seeking a highly experienced FDA BIMO Inspections and Compliance Consultant to serve as a subject matter expert supporting modernization and consolidation of BIMO inspection and compliance practices. The ... - Apr 21
I.P. - Technology Transactions (Life Sciences) Associate
Direct Counsel
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Washington, DC, 20001
235000USD - 310000USD per year
... Digital health technologies Clinical development and FDA regulatory pathways Experience working with AI-native or AI-driven life sciences companies—particularly those applying machine learning to drug discovery, diagnostics, or R&D—is a strong plus. ... - Apr 21
Research Assistant
Pediatric Specialists of Virginia
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Merrifield, VA, 22042
Overview The employee must adhere to GCP, FDA, and Pediatric Specialists of Virginia guidelines when implementing research trials to ensure the highest quality research within PSV. Communicates effectively and works in collaboration with the ... - Apr 18
Quality and Compliance Specialist
Apothékary
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Lorton, VA, 22079
... marketing materials Regulatory Compliance: Support review of product labeling and marketing materials for compliance with FDA/DSHEA standards and retailer requirements Monitor and interpret changes in federal, state, and international regulations ... - Apr 07
Clinical Trials Subject Matter Expert (SME)
Prometheus Federal Services
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Fairfax, VA
... protocol adherence Direct and facilitate cross-functional meetings with internal teams, and external stakeholders, including FDA representatives, industry sponsors, and VA research groups, to advance DCT initiatives Author, review, and contribute to ... - Apr 21
Associate Director, Clinical Quality Assurance
Kolon TissueGene, Inc.
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Rockville, MD, 20849
... Ensure quality processes and systems meet FDA and global regulatory expectations. Oversee electronic quality systems supporting training management and GxP document control. Clinical Quality Oversight Drive the GCP Quality strategy across clinical ... - Apr 17
Scientific Systems Engineer
SAIC (Science Applications Int.)
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Takoma Park, MD, 20901
Description SAIC is seeking a qualified Senior Scientific Systems Engineer to support FDA operations. This role provides advanced scientific computing support to FDA scientists within the Center for Drug Evaluation and Research (CDER) in Silver ... - Apr 15
EHS Manager (GMP experience )
Granules Pharmaceuticals
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Chantilly, VA, 20151
... Ensure compliance with OSHA, FDA, EPA, GMP, and applicable state and local regulations Lead site risk assessments, job hazard analyses, and safety audits Investigate incidents, near-misses, and safety concerns; implement corrective and preventive ... - Apr 18
Program Manager, Strategic Planning
Kolon TissueGene, Inc.
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Rockville, MD, 20849
... TG C is advancing toward Biologics License Application (BLA) submission to the FDA, the most consequential regulatory milestone for a biologic therapy. In parallel, KTG is expanding its clinical pipeline into additional indications, including ... - Apr 21
Enterprise Platform Administrator / Implementation Specialist
NIRA, Inc.
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Langley Park, MD, 20783
100000USD per year
Job Description NIRA Inc., a fast-growing women-owned small business headquartered in Washington, DC, is seeking an Enterprise Platform Administrator / Implementation Specialist to support a critical FDA mission. Our ideal candidate has strong ... - Apr 21