• Daiichi Sankyo, Inc. (Bernards, NJ)
    …to anti-kickback, false claim, and transparency reporting laws/regulations for additional DSI Compliance or Legal Affairs review .- CBER MeetingsWhen live CBER ... Summary This position will be part of the Global Compliance & Risk Management organization and will report directly...be responsible for supporting the global Cross Border Engagement Review (CBER) process and will also serve as the… more
    HireLifeScience (09/24/24)
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  • Merck & Co. (North Wales, PA)
    …expertise in our company's internal processes and policies, especially in compliance , Medical/Legal review of materials, reimbursement procedures, and related ... their lifecycles, offer structuring for copay programs, ensuring government compliance , managing high-impact vendor relationships, leveraging consumer data analytics,… more
    HireLifeScience (10/29/24)
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  • Merck & Co. (Rahway, NJ)
    …updates.Supports device sites with the collection and analysis of data for management review . Reports to - Director Regulatory Compliance , Device Quality and ... Job DescriptionPosition Title -Director/ Principal Scientist, Regulatory Compliance Department - Device Quality & Regulatory Brief Description of Position- This… more
    HireLifeScience (10/25/24)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review submission data package ... of this job is to oversee statistical vendor deliverables, perform programmatic review of analysis datasets and Table, Listing, and Figures (TLFs) generated by… more
    HireLifeScience (10/23/24)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …for US, EU and Company Core documents as well as for the review of country labeling deviations.Ensure Compliance with Labeling Regulations and Guidance: ... and maintenance of the CCDS, US and EU labeling, and manages the review of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance more
    HireLifeScience (11/02/24)
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  • Aequor (Thousand Oaks, CA)
    …and standards are understood and followed. Contribution: Consistent with 's Healthcare Compliance Policy and Standard Operating Procedures: o Review proposed ... 1: More transactional - receiving contracts - data entry to c3 compliance system using templates, generating agreements, and processing invoices. Ensuring … more
    HireLifeScience (10/11/24)
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  • Merck & Co. (Durham, NC)
    …facilities, utilities, manufacturing, packaging, labeling, and laboratories to ensure compliance with company policies, procedures, and regulatory expectations. Be ... specifications, reports and computerized system related changes to ensure compliance to company standards and applicable regulations throughout the computerized… more
    HireLifeScience (10/29/24)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents supporting GLP/non-GLP/ Research submissions to Health ... a phase appropriate quality system that supports quality and compliance of Good Clinical Laboratory Practices and Good Laboratory...internal and external oversight.Manage and/ or guide the QA review and approval of GLP and GCLP study protocols,… more
    HireLifeScience (10/23/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …Medical Education and ensure that assigned programs are funded and executed in compliance with these guidelines. Participate in the review and evaluation of ... (eg, clinical overviews, formulary dossiers, online evidence repository). Ensure compliance with FDA requirements as they affect medical communications; responses… more
    HireLifeScience (09/05/24)
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  • Merck & Co. (Durham, NC)
    Job DescriptionSenior Specialist, Quality Systems and Compliance (P3) Our company is expanding its global recombinant vaccine production network by investing and ... for daily support and oversight of all production processes to ensure compliance with regulatory requirements as well as policies and procedures.- Responsible for… more
    HireLifeScience (10/31/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …to establish and maintain processes, procedures and controls to ensure compliance with all relevant internal and external requirements and regulations relating ... and other safety information in the US and Canada. Overall responsible for compliance with US drug and device safety reporting regulations, Health Canada regulations… more
    HireLifeScience (10/05/24)
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  • Merck & Co. (Rahway, NJ)
    …of regulated documentation in support of the clinical development portfolio and compliance in public disclosure of clinical trials and their results, document ... for preparing clinical study registration and results disclosure postings in compliance with company policy and country laws and requirements. The disclosure… more
    HireLifeScience (11/02/24)
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  • Eisai, Inc (Nutley, NJ)
    …Management Lead is responsible for overseeing the entire portfolio of IT Compliance responsibilities from both the strategic and execution perspectives for Eisai. ... Reporting directly to the Executive Director, IT Security, Compliance , & Architecture, s/he is the Global IT department's trusted leader and manager who assesses and… more
    HireLifeScience (10/17/24)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …for US, EU and Company Core documents as well as for the review of country labeling deviations.Ensure Compliance with Labeling Regulations and Guidance: ... by managing labeling development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to Core Data Sheets for… more
    HireLifeScience (09/24/24)
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  • Aequor (Houston, TX)
    …the integrity and efficiency of our Quality Management System, ensuring compliance with industry standards, and facilitating various audit processes. The ideal ... tasks and manage timelines effectively.Preferred Skills:- Familiarity with regulatory compliance standards and quality assurance processes.- Experience in audit… more
    HireLifeScience (11/02/24)
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  • Merck & Co. (North Wales, PA)
    …Leadership, Account Executive Leadership, US Market Operations, IT, Training, Compliance , Legal, and Communications.-Key responsibilities of the Digital Channel SME, ... US Market Operations, Digital Publishers, Creative Agencies, IT, Training, Compliance , Legal and Communications as appropriateManage Digital Channel Capabilities to… more
    HireLifeScience (11/02/24)
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  • Merck & Co. (Rahway, NJ)
    …global plans and programs, draft plan documents and amendments and review employee benefit related communications, including annual enrollment materials and summary ... plan descriptions Assist with all aspects of legal compliance with respect to the company's US and Puerto...benefits claims/appeals and related litigation Work with internal benefit review committees to respond to severance, savings and pension… more
    HireLifeScience (10/31/24)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …coordination, and implementation of Development SOP activities to ensure regulatory compliance and cross functional cohesiveness across SOPs and related documents ... with the appropriate stakeholders to ensure timely remediation.SOP Authorship and Review Maintain a close working relationship with Quality Assurance and participate… more
    HireLifeScience (10/03/24)
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  • Merck & Co. (North Wales, PA)
    …to the Director/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and ... objectives.Serve as the liaison and manages correspondence with FDA's promotional review divisions Office of Promotion and Advertising Review (OPDP)/Advertising… more
    HireLifeScience (10/31/24)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …OLT with assessing portfolios, preparing documents and communications, and conducting a final review of materials prior to OLT submission. This position acts as a ... "change agent" within DS to ensure compliance and alignment with DS highest standards. This position...Coordinator in the fulfillment of their duties. This includes review and editing of OEDC communication, including the website,… more
    HireLifeScience (09/24/24)
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