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Serves as a Criminal Investigator in the Office of the Inspector General with the responsibility under the direction of the Assistant Inspector General for Investigations, to perform such investigations and event inquiries as may be required to assure the integrity of operations of the U.S. Nuclear Regulatory Commission (NRC) and Defense Nuclear Facilities Safety Board (DNFSB.
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Assure effective development, implementation, and monitoring of budgets for assigned management units e.g., speech-language pathology, government affairs and public policy, special interest groups and international affairs.
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Collaborate with clients, regulatory agencies, and internal teams, including VIKA’s Engineering, Landscape Architecture, Surveying, and Planning Staff, as well as external consultants, to facilitate project coordination and communication.
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Keeps abreast of and ensures compliance with regulatory practices (e.g. FDA, EMA, and ICH guidance and recommendations) and industry data standards (e.g. CDISC). Represents Emmes at Sponsor, Regulatory, Investigator or Safety Review meetings (e.g., Data and Safety Monitoring Board Meetings.
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He/she works closely with Director, Clinical Supplies, Clinical Operations, Clinical Research, CMC, Regulatory Affairs CMC, Supply Chain, QA, Finance and contracted CROs and external clinical supply vendors to forecast and manage clinical supply and ancillary supply needs and timelines for clinical trials.
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You will also ensure that operations are aligned with the cGMP standards established by AstraZeneca and relevant regulatory agencies. - Extensive working knowledge of international Cell Therapy GxP regulatory frameworks, regulations, and guidance.
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The Scientist will provide subject-matter expertise in a range of translational research strategies, immunoassay techniques, assay development, and fit-for-purpose Regulatory approach. Responsibilities include coordinating and analyzing samples using immunoassays (ELISA, Luminex, Meso Scale, etc) and cell assays (flow cytometry), maintenance of biobanks and inventories, developing assays, and reporting to cross-functional teams.
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Reproductive toxicologists are subject matter experts in the interpretation of Developmental and Reproductive Toxicology (DART) data advising project teams accordingly and exploiting this knowledge to facilitate regulatory submissions.
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Thorough understanding of the cross functional drug development processes (Clinical Operations, Biometrics, and Regulatory Affairs) and context applicable to safety surveillance activities required.
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Participate in community affairs and maintain positive public image for the property and HEI Hotels and Resorts. For your physical and mental wellness we offer competitive Medical and Dental programs through Anthem Blue Cross Blue Shield as well as Vision insurance programs.
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The Montgomery County Department of Housing and Community Affairs (DHCA) is currently seeking to fill two Housing Code Inspector positions. Montgomery County Government is an equal opportunity employer, committed to workforce diversity.
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Experience in clinical trials and other areas of pharmaceutical medicine (i.e. medical affairs, regulatory, pharmacovigilance, etc.) Works directly with the Global Head of Pharmacovigilance and Medical Monitoring, in managing both corporate and project-related activities.
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Experience must include 6 months in each of the following: Big Query; SQL; Tableau; Python; business systems integration and networking; coding, scripting, modeling, and technical analysis; project management; and technical presentations.
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Associate Principal Investigator, Market Regulation - Market Investigations, Customer Order Handling
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Cause to believe violations exist of applicable rules and securities laws, under FINRA or Regulatory Service Agreement (RSA) jurisdiction, related to securities market regulation. FINRA is a registered trademark of the Financial Industry Regulatory Authority, Inc.
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Do you have previous experience in animal care and/or control (e.g., animal services officer, veterinarian assistant, attendant at an approved kennel) or regulatory compliance and enforcement, law enforcement, military, or related field.
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regulatory affairs jobs Title: regulatory affairs project manager in Germantown, MD
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