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Experience reviewing applicable federal statutes and regulations, including a strong understanding of laws and regulations related to research and sponsored activities (e.g., FAR/ DFAR, Uniform Guidance, Intellectual Property, FCOI, IRB/IACUC/IBC, Data/Privacy, Export Controls, etc.
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Oversee quality assurance activities to ensure the integrity, accuracy, and compliance of clinical trial data within Veeva Vault applications, in accordance with regulatory requirements (e.g., FDA guidelines, GCP standards.
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O Coordinate delivery and completion of nonclinical research activities, including preclinical studies, pharmacology, pharmacokinetics, toxicology, bioanalytical, and CMC. o Ensure alignment of biomarker and diagnostic development activities with overall project goals and regulatory requirements.
Full-timeExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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Please note that qualifying specialized work experience may have been gained through a variety of activities, including residence, study, teaching, business or commercial activities, military service, newspaper work, military or civil government activities, missionary or international relief work, or other foreign work experience.
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The health and safety engineer will inspect, train and advise our employees on potential jobsite hazards or unsafe activities. Job Type : Safety Engineer, HSE Manager, Safety Director, Safety Manager, Health & Safety Specialist.
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Lead statistical programming activities for regulatory submissions following CDISC standards. As the Principal Statistical Programmer reporting to the Senior Director of Statistical Programming, you will be accountable for all statistical programming deliverables in adherence to company SOPs and ICH/GCP. You will also help to create and implement Statistical Programming policies and procedures.
$189,000 - $201,000 a yearFull-timeExpandApply NowActive JobUpdated 27 days ago - UpvoteDownvoteShare Job
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Lead and manage commercial QA oversight program including manufacturing, packaging and labeling, serialization, direct to practitioner sample program, third party logistics activities, to ensure compliance with DCSCA and associated regulatory requirements.
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Moderna is seeking a Director of Epidemiology, Early HEOR & Patient-Centered Outcomes Assessment (Epi, & PCOA) to support the strategy, design and implementation of evidence generation activities activities targeted towards supporting the regulatory approval and reimbursement.
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Responsible for Quality & Controls Assurance programs, activities and reviews, including claims reviews; call center and digital communications reviews; Medicare Risk Adjustment, HCC, clinical and coding reviews; DRG and medical records reviews; technology/systems and coding upgrade and implementation reviews (e.g. final user acceptance testing, etc.
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Understanding of cell line development and CMC activities. Knowledge of techniques and instrumentation related to protein characterization and analytics (SPR/BLI binding, LC/MS, peptide mapping, PTM characterization, HPLC, DSC, DLS, etc.
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Event Planning and Execution: Direct the planning and execution of non-festival events, experiential marketing activities, and grassroots initiatives to amplify brand presence. We're in search of a Senior Brand Activation Manager who will serve as a dynamic leader, driving our brand's presence and growth within the competitive landscape of the alcohol industry.
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You will oversee cash management, credit administration, and foreign exchange (FX) hedging activities, as well as spearhead efforts in the centralization of operations, banking optimization, and foreign cash repatriation.
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Oversees the development, implementation, and evaluation of the Ryan White Clinical and EHE Quality Management Plans, annual workplans, and program activities that are aligned with programmatic goals and objectives, including performance and program evaluation measures utilizing a racially just and equitable framework.
Full-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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This includes performing daily portfolio management activities, such as rebalancing risk and evaluating tactical relative-value tradeoffs, but also leading simulation and back testing projects to research alternative hedging strategies.
$137,800 - $180,800 a yearExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Some areas where these activities would take place include Trade Entry, Foreign Exchange Processing, Trade Settlement, Corporate Action Processing, and Research Notification. The Finance Associate is responsible for performing specialized operational securities processing activities in support of the firm's business lines.
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traditions activities jobs in South Boston, MA
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