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Manage trafficking of marketing campaigns within the client’s content approvals ecosystem – support necessary regulatory and compliance reviews by packaging and submitting materials; prepare responses to reviewer feedback; manage version control and troubleshoot any conflicting feedback to ensure timely and compliant delivery of approved campaign assets.
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Ensures compliance within guidelines set forth by regulatory agencies (DPH, ERISA etc.) Responsible for psychosocial assessments and interventions in crisis situations that often involve issues of suicide, homicide, family violence, elder or child abuse.
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The Clinical Trial Manager, Site Start-up will lead internal process improvements related to study start up activities to ensure clinical trials are executed with high quality standards in compliance with regulatory requirements, GCP, and company SOPs. This role is based in our Waltham, MA headquarters.
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Subject matter expertise in matters pertaining to behavioral threat assessment, both international and domestic (U.S.) affairs, and violent extremism as they pertain to the current threat environment.
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Executes model risk management activities and projects consistent with the Enterprise MRM framework, industry best practices, and regulatory guidance. The incumbent is also responsible for addressing and executing model risk management activities consistent with framework, best practices, and regulatory guidance.
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Maintains established hospital and department policies and procedures, objectives, quality assurance, safety, environmental and infection control and complies with requirements of accreditation and regulatory agencies.
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Lead Trinity’s internal client auditing and external client audit activities, which requires working knowledge of Life Science regulatory requirements contractually passed through to its vendors like Trinity (e.g., pertinent FDA regulations, pharmacovigilance, data privacy, transparency reporting, etc.
$150,000 a yearExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Ten (10) years of regulatory experience for small molecules and biologics within the pharmaceutical or biotechnology industry, along with demonstrated success as a PV, Regulatory Affairs organizational leader, able to lead, direct and develop member of the PV regulatory function.
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Join us as an Assistant Project Manager! Assist project managers with a variety of tasks from project start-up to close out. Some of our clients include HP Hood, Coca Cola, Amazon, Jet.com, Cumberland Farms, Daniele Foods, Maines Paper & Foodservice, Reinhart Foodservice, Blount Fine Foods and many others.
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Ensure all regulatory trainings and approvals are met before and after all grant submissions and awards are made, including but not limited to IRB, IACUC, FCOI and so forth as applicable. Participate in the development and implementation of new internal policies, procedures or practices to ensure compliance in the conduct of research applicable with federal regulations, state and all other regulatory bodies governing grant compliance.
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Author, review and strategically impact CMC sections (Pre-IND, IND, BLA, & MAA submissions)Manage upstream and downstream scientistQualifications:M.S or Ph. D. in Pharmaceutical Sciences or a related scientific field w/ ideally 10 or more years of industry experience & prior management experienceExperience working cross functionally with senior leadership (QC, Analytical, Manufacturing, Regulatory, Business Development, etc.
$210,000 - $240,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Ability to work independently to identify problems and solutions that meet the occasionally competing needs of research, other internal departments, sponsoring agencies or regulatory bodies. Remain abreast of current trends, practices, regulatory and/or policy changes of granting entities, which may impact internal processes or programs.
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Develop a Site Initiation Management Plan and coordinate regulatory and ethics committee submissions and perform day to day management of the study start up activities for clinical studies. ·Partners with Clinical Operations, Medical Affairs/local country offices to obtain local insights into country and site selection.
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Leads clinical program(s) and acts as a clinical expert and leader in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards), internal stakeholders (e.g., Research, Regeneron Genetics Center, Regulatory Affairs, Global Clinical Development, Precision Medicine, HEOR), and internal decision committees.
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Clinical Trial Initiation Manager will deliver high quality and timely global study start-up. The Clinical Trial Manager, Site Start-up will serve as an expert in study start-up practices by initiating efficient start-up activities and removing obstacles for study teams.
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regulatory affairs jobs Title: regulatory affairs project manager Company: Aerotek in Cambridge, MA
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