• Eisai, Inc (Nutley, NJ)
    …2 years of experience with Document Management Systems in job offered or as Senior / Regulatory Affairs Associate /Officer. Also requires 2 years of experience ... Information Systems are supported and managed according to business need and regulatory compliance . Capture and implement system enhancements to optimize their… more
    HireLifeScience (03/08/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …to regulatory process optimizations on relevant topics.Responsibilities- Supports CMC regulatory compliance activities for portfolio biologics to meet US, ... research areas centered around rare diseases and immune disorders.Summary The Associate Director, RACMC Portfolio Products, will be responsible for regulatory more
    HireLifeScience (03/01/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    …to manage multiple clinical trials (all phases), and ensure compliance with SOPs, FDA regulations, GCP, ICH guidelines, etc.ResponsibilitiesAdditional representative ... study team with audits/inspections for CRO/vendors in preparation of regulatory body inspections and potential vendor contracts.Responsible for the collection… more
    HireLifeScience (02/16/24)
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  • Eisai, Inc (Nutley, NJ)
    …be primarily responsible for providing counsel specific to Eisai's pharmaceutical regulatory needs, including sales and marketing, scientific exchange and other ... labeling, sales training and media/digital materials. Works to ensure Eisai's compliance with pharmaceutical laws including the Anti-Kickback Statute, False Claims… more
    HireLifeScience (01/04/24)
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  • Merck & Co. (Durham, NC)
    Job DescriptionPosition Description: Senior Specialist, Manufacturing Automation The Senior Specialist Manufacturing Automation person is primarily responsible ... to improve manufacturing performance, and maintaining the automation systems in compliance with cGMPs. The Manufacturing Automation Sr. Specialist must actively… more
    HireLifeScience (03/22/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …marketing, market access, commercial insights and analytics, sales, medical/CMR, legal, compliance , and regulatory . Other internal relationships include Public ... Field Access, and Payer), Brand Marketing, Training, Market Access, Trade, Legal, Compliance , Finance, HEOR, and Market Research. The position has high exposure to… more
    HireLifeScience (03/27/24)
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  • Merck & Co. (Millsboro, DE)
    …to our Company guidelinesBrings together the right stakeholders to ensure compliance and sustainability of IT/OT solutionsParticipate in regulatory audits ... Job DescriptionPosition Description: Associate Director - Site Digital Technology Lead The Site Digital Technology Lead is the representative for Global Animal… more
    HireLifeScience (03/22/24)
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  • Novo Nordisk Inc. (Boulder, CO)
    …analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder, ... cost & timely completion of all validation deliverables. Relationships Associate Director. Essential Functions Perform, review & approve validation/revalidation.… more
    HireLifeScience (03/23/24)
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  • Merck & Co. (Durham, NC)
    Job DescriptionPosition Description: Senior Fermentation Operations Technician (Days) This position is in direct support of our Upstream Fermentation manufacturing ... Tangential Flow Filtration, Process Monitoring, Sampling, and area cleaning. As a Senior Technician you will be an energetic leader with strong interpersonal,… more
    HireLifeScience (03/19/24)
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  • Merck & Co. (Durham, NC)
    Job DescriptionPosition Description: Senior Technician, Maintenance The Senior Maintenance Technician is responsible for providing equipment troubleshooting and ... Quality, Automation, Technology, and other groups as required.-The Lab Senior Maintenance Technician will provide maintenance supporting vaccine process equipment… more
    HireLifeScience (02/28/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …assets are easily accessible and properly utilized. Relationships Reports to the Associate Director of Content Management; Provides direct support to the Digital ... multiple NNI internal functions such as Brand Managers, Omnichannel teams, IT, Regulatory and Commercial Insights & Analytic, as well as external operational vendors… more
    HireLifeScience (03/19/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration… more
    HireLifeScience (03/21/24)
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  • Merck & Co. (Durham, NC)
    …operable.Responsible for performing assignments in conformance with appropriate Regulatory (GMP's) and department Standard Operating Procedures which assure ... maintenance (PM) plans/calibration procedures, task lists, etc., as required.Work compliance systems for maintaining PM program and assessing equipment -… more
    HireLifeScience (02/28/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …and evaluates IT systems risks and vulnerabilities Applies expert knowledge of compliance with all security, regulatory and quality policies and procedures ... area of responsibility Leverages technology principles, knowledge and practices: Ensures compliance with the NN Software Development Life Cycle (SDLC) deliverables… more
    HireLifeScience (03/06/24)
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  • Eisai, Inc (NJ)
    …this is your profile, we want to hear from you. Job Summary The Associate Director, Clinical Outsourcing, will oversee and lead and support activities related to the ... and functional service providers for Eisai's R&D functions. This role will ensure compliance with key processes and manage the outsourcing team. The ideal individual… more
    HireLifeScience (02/01/24)
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  • Astellas (Westborough, MA)
    …Operations Scientist Manufacturing Associate I/II Senior Associate , Manufacturing Science and Technology Compliance Specialist Manager, Quality ... Systems Senior Manager, Quality Assurance Quality Systems Engineer Research Associate II, Analytical Development Senior Project Manager, Technical Operations… more
    HireLifeScience (01/14/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …development and review of regional / global policies and procedures. Ensure compliance with all Company and Regulatory requirements.Work with outsourcing ... as other research areas centered around rare diseases and immune disorders.SummaryThe Senior Director of Clinical Operations will manage clinical operations staff to… more
    HireLifeScience (03/01/24)
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  • US_Sr. AD, Regulatory Compliance

    Boehringer Ingelheim (Ridgefield, CT)
    …programs reflect Boehringer Ingelheim's high regard for our employees. The Senior Associate Director, Regulatory Compliance & Training, Q Dev US will ... and act as a Divisional Management System Owner for regulatory training in US, Germany, and Japan. This role...Japan. This role will lead, plan, and organize centralized compliance training program in R&D. The incumbent will design… more
    Boehringer Ingelheim (03/14/24)
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  • Senior Associate General Counsel…

    Hawaiian Electric (Honolulu, HI)
    Senior Associate General Counsel ( Regulatory & Litigation) Date:Mar 24, 2024 Location: Honolulu, Hawaii (HI), US, 96840 Company: hawaiianel We recognize our ... related issues affecting the Companies, including: assessment of legal, regulatory compliance and business risk; representation of...Kahului - Maui Hiring Range:The hiring range for the Senior Associate General Counsel ( Regulatory more
    Hawaiian Electric (01/03/24)
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  • Senior Regulatory Compliance

    CareFirst (Baltimore, MD)
    **Resp & Qualifications** **PURPOSE:** This Senior Regulatory Compliance Analyst position will conduct independent analysis for complicated, high level ... regulatory inquiries and provide interpretation of regulatory rules and guidelines to demonstrate compliance ...required work experience. **Experience:** 5 years experience in a compliance or senior level customer service role.… more
    CareFirst (03/09/24)
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