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CDM Smith is currently seeking a GIS professional in various geographical locations to serve as flood risk study manager and quality reviewer in support of FEMA Risk MAP (Risk Mapping, Assessment, and Planning) activities nationwide.
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The QA Reviewer is responsible for a variety of Quality activities to ensure compliance with applicable quality objectives and regulatory requirements in the cGMP Quality organization. Work with manufacturing and laboratory management to ensure activities comply with regulatory requirements.
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Work with the Capture Manager to determine author and reviewer assignments and to integrate win strategy, themes, proof points, and discriminators into proposal outline. Position Title: Proposal Manager Location: On Site in McLean, VA ROLE DESCRIPTIONThe Proposal Manager is responsible for leading, planning, scheduling, and overseeing the timely development and delivery of high-quality responses to federal government business opportunities, from opportunity qualification to post-submission activities, in a growing, fast-paced, service-oriented environment.
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To be considered for this role, you must have an MD required and a minimum of >5 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. Additionally, >3 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, implementing, reporting and publishing), or section of clinical programs in a global/matrix environment in pharmaceutical industry.
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As Reviewer-in-Charge of assigned reviewable units or commercial risk segments, this role executes continuous quarterly credit file examination activities, ad hoc targeted loan review engagements, and quarterly written analyses of the credit risk trends of the loan portfolios of assigned reviewable units or risk segments.
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Examples of such experience may include independent responsibility for a well-defined study or for a phase of a larger study that required the planning and carrying out of routine physical science work related to mining and mineral processing industry, production operations and/or exploration activities; performing nonfuel mineral commodity supply chain analyses; compiling data from statistical surveys of mineral producers, evaluating results, and preparing tables for publication.
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Technical reviewer and author for NDreadiness activities related to parenteral drug products. Experienced in writing and reviewing technical documentation for GMP activities and process validation at partnering CMOs, such as master batch records, executed batch records, risk assessments, process characterization protocols and reports, change controls, and master validation plans, protocols, and reports.
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Experience in fire alarm and fire sprinklers as a designer, plan reviewer or inspector. The Fire Department of the City and County of Denver is seeking a Senior Engineering Associate for a wide variety of activities, including (1) performing plan review for fire alarm and fire sprinkler shop drawings (2) performing plan review for construction design documents for new and existing buildings and (3) conducting technical inspections of structures and occupancies.
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Thus, the candidate should also have an understanding of various clinical trial activities such as Clinical Trial Management Services, clinical monitoring, data management, Real World Data/Evidence (RWD/RWE), biostatistics, medical writing, Ph 1 CRU, central lab, biomarker lab, bioanalytical lab, RTSM, eCOA, medical imaging, safety, e-informed consent, mobile HCP services, telemedicine and wearables/sensors.
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Advising the National Human Trafficking Coordinator (NHTC), HTPU Director, and HTPU Deputy Directors for Litigation on strategies for enhancing HTPU's policy and program activities, including outreach, training, strategic guidance, coordination, compliance, stakeholder engagement, victim assistance, and policy advocacy efforts.
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The Proposal Specialist is responsible for leading, planning, scheduling, and overseeing the timely development and delivery of high-quality responses to federal government business opportunities (e.g. requests for information (RFIs), quotes (RFQs), and proposals (RFPs), from opportunity qualification to post-submission activities, in a growing, fast-paced, service-oriented environment.
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Proclinical Staffing is seeking a Senior Scientist, Formulation Process Development to join a clinical-stage pharmaceutical company. Senior Scientist, Formulation Process Development - Permanent - Onsite.
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Serves as the principal reviewer of developed verification procedures for executing risk assessments and security test and evaluations, and conduct risk assessments to ensure that systems are operating securely.
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Daily activities will include, but are not limited to, working within a team environment and leading functional internal audits of VO’s electronical Trial Master File (eTMF) and Contract Repositories to ensure meticulous oversight of VO’s documentations, adherence to work procedures, compliance standards, and the preservation of data integrity.
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Collaborate with Post-Market Surveillance team to establish a robust process for overseeing the management of all post-market sustaining activities required to maintain global market access. Independent reviewer on design control projects to ensure compliance with internal regulations and external standards.
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