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At Author Health, we are a new company offering technology-enabled health care services for seniors with complex mental health conditions. Build a modern and beautiful product that shapes the user experience for Author Health’s members, caregivers, and providers.
RemoteExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Contribute to protocol development and author statistical analysis plans. Proficient in statistical programming (SAS and R). Support IND/NDA/MAA regulatory submissions and address queries from regulatory agencies.
Full-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Author, review and approve technical documents, including but not limited to study protocols, process development and validation reports, batch records and process/manufacturing sections of regulatory documents.
Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Author ADME/DMPK sections of regulatory documents (e.g., IND/IB). Hands on experience conducting, troubleshooting, and summarizing in vitro and in vivo ADME/DMPK studies is required. Define strategy for in vitro/in vivo DMPK and DDI risk assessment for drug candidates.
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The individual in this position will be responsible for leading and executing specific aspects of the FLRC Regulatory Management Services (RMS) program, including leading global staff with the required expertise to manage regulatory finding remediations, work with Management to develop and inventory remediation closure materials, and to author impactful closing documents with relevant supporting metrics and details for consumption by the Lines of Defense (LOD) and various regulatory agencies.
$185,000 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Ability to compile data results and author commentary on industry studies is a plus. Experience with ANY of the following technologies: SQL Server Reporting Services (SSRS), SSIS Reporting, Power BI, Dynamics CRM, Dynamics GP, SharePoint, Excel, Power Query, Power Pivot.
Full-timeRemoteExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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Author and maintain detailed validation documentation, including protocols, reports, and deviations. Proven experience with commissioning and qualification of equipment such as bioreactors, chromatography systems, and HVAC systems.
ExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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In depth Experience in Duck Creek Policy admin system, Author, Page builder, with a comprehensive understanding of underwriting, billing, rating, insurance rules, and forms; Experience with Duck Creek policy platform version 8.
Full-timeExpandApply NowActive JobUpdated 4 months ago - UpvoteDownvoteShare Job
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The qualified candidate will apply knowledge and technical expertise in in vitro and in vivo ADME and PK to drive project team strategy. Represent the DMPK function on cross-functional discovery teams and provide technical and scientific expertise for ADME profiling and interpretation of the data.
Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Update, author and review FEV standard operating procedures and other controlled documents as a result of process improvements and CAPAs, Gap Assessments. Demonstrate a sound understanding of cGMP's, FDA regulations, and pharmaceutical manufacturing/packaging processes.
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This position is expected to lead large, complex projects – including process mapping, exploring and articulating business problems and with solution architects turn these into technical solutions, author recommendations and present to stakeholders.
Full-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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SME Experience in systems like Labvantage LIMS(Must), MES, etcHands on Validation/Test lead who manages and drives GxP and non GxP deliverables who can author, execute, review and approve deliverables Micro Focus ALM (Client ALM.
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Prepare regulatory submission documentation, author in vivo pharmacology sections of regulatory documents. Delphia is searching for a Principal Scientist / Associate Director, In vivo Pharmacology to join the team.
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Substantial clinical study protocol experience, as lead author, required. Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias.
Full-timeRemoteExpandApply NowActive JobUpdated 6+ months ago - UpvoteDownvoteShare Job
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Author toxicology risk assessments for impurities, extractables and leachables, contaminants, excipients, and in silico mutagenicity assessments for drug manufacturing functions. Author PDE monographs and occupational exposure limits (OELs) in support of EHS and Quality interfaces.
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author job in Quincy, MA
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