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Author post-market surveillance reports. Author and support regulatory filings for market clearance, licensing, registration, and legalization. The Principal Regulatory Specialist is responsible for carrying out Pre-Market and Post-Market regulatory activities in compliance with Digital Factory’s Quality Management System for domestic and various international markets for SaMD products.
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Author audit reports and coordinate supporting documentation; manage same in QMS. Author audit reports and coordinate supporting documentation; manage same in QMS. Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease.
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The job purpose and scope of the Clinical Research Scientist is to author the scientific documents associated with design, conduct, and reporting of clinical trials in the therapeutic area of Heart Failure, particularly mechanical circulatory support and hemodynamic monitoring.
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Author white paper solution articles for publication to the user community through our support web knowledge base. such as Aspen Plus and Aspen HYSYS. Are you a recent college graduate or are you preparing to graduate this Winter or Spring.
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Author and oversee DMPK/clinical pharmacology related sections of health authority communication documents including regulatory meeting briefing documents, IB, pediatric investigational plans (PIP) and popPK modeling/simulation reports.
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Ph. D. in Proteomics, Biological Sciences, Bioinformatics, Statistics, Analytical Chemistry or a related field with experience in one or more of the following areas as demonstrated through at least one first-author publication: Computational biology, Bioinformatics, Proteomics, Machine Learning.
$60,900 - $101,500 a yearFull-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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Author technical documentation on SOLIDWORKS PDM configuration documentation, functional design documents, test plans, and develop and facilitate user training. Author technical documentation on SOLIDWORKS PDM configuration documentation, functional design documents, test plans, and develop and facilitate user training.
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The Lead Risk Intelligence Analyst will research, analyze, and author intelligence assessments using both internal and open-source materials to produce and distribute intelligence products through approved channels.
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Ability to identify and author required documentation to correct drawing to actual hardware discrepancies. Experience writing, editing and supporting existing software code base (LabVIEW or C.
$80 - $96 an hourFull-timeExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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Subject matter expert in Radio Frequency or Microwave systems and subsystems. Candidate must be able to obtain a secret security clearance and must be able to obtain at least an interim secret clearance prior to start.
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Serves as an TAS Internal Revenue Manual (IRM) author, including updating IRMs, developing Interim Guidance Memorandums (IGMs), and issuing IRM Procedural Updates (IPUs). Serves as the program specialist to develop, maintain, evaluate, and provide training on guidance, policies, and procedures on specific technical tax issues in relation to TAS intake and case advocacy operations that are TAS-wide in scope and have significant impact on cases in TAS.
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Author labeling literature (IFU, Patient Implant Leaflets), review package labeling, and review advertising/promotional material. Author and compile product submissions and technical files.
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Drive projects to improve the QMS for compliance through Trackwise (TW), efficiency, or corporate needs Author/revise standard operating procedures (SOPs) and test methods, as required Other duties as assigned Work Conditions: Office Physical Requirements: Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, stoop, kneel, crouch or crawl, climb or balance Talk or hear Close vision Computer/office machines Lift up to 10 lbs.
Full-timeExpandApply NowActive JobUpdated 21 days ago
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