- Eisai, Inc (Nutley, NJ)
- …hear from you.The Director, Global IT Governance, Risk & Controls Management Lead is responsible for overseeing the entire portfolio of IT Compliance ... local, regional, and industry standards.Work with non-IT compliance staff (legal, audit , corporate compliance).Focus on compliance risks and define, implement and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …drive initiatives aimed at enhancing operational efficiency and effectiveness Compliance and Audit Support Support internal and external audits related to legal ... project management activities across the legal department. Relationships Reports to Lead , Legal Operations and Projects. Partners and collaborates with internal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …local authorities as necessary to address compliance relevant matters and lead any remediation efforts. ResponsibilitiesLeads nonclinical QA function to implement a ... of GLP/GCLP systems, risk management processes such as SOPs for QA activities for internal and external oversight.Manage and/ or guide the QA review and approval of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(IRBs), and other site personnel as neededStudy-specific subject matter expert (SME) for internal audit or Health Authority (HA) questions related to medical ... for one or more clinical trials Matrix management responsibilities across the internal and external network Manages Phase 1-3 studies (depending on assignment) with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position provides expertise within Data Management by partnering with internal and external stakeholders (eg Central Labs, Specialty Labs, Biomarker Vendors, ... / Therapeutic level external data collection requirements by partnering will internal (BDM, Non-BDM Functions) and external stakeholders (Central Labs, Vendors,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and other site personnel as needed- Study-specific subject matter expert (ME) for internal audit or Health Authority (HA) questions related to medical ... oversight for one or more clinical trials Matrix management responsibilities across the internal and external network Manages Phase 1 - Phase 3 studies (depending on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(IRBs), and other site personnel as neededStudy-specific subject matter expert (ME) for internal audit or Health Authority (HA) questions related to medical ... oversight for one or more clinical trials Matrix management responsibilities across the internal and external network, Manages Phase 1 - Phase 3 studies (depending… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders.SummaryThis position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple early-stage programs, in ... safety surveillance and risk management in partnership with Product Safety Lead (s), Clinical Safety Physician(s), and cross-functional team in support of benefit… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as Subject Matter Expert (SME) and mentor colleagues/direct reports in audit /inspection preparedness and participation Serves as NAO's Lead regarding ... processes, procedures and controls to ensure compliance with all relevant internal and external requirements and regulations relating to technical complaints,… more
- Merck & Co. (Millsboro, DE)
- …Management System Periodic review and revision of SOPs Participate in the sites Internal Audit Program Perform Finished Product Sampling as needed. - Required ... Quality Reports). - All functions would be executed in compliance with internal standards, 9CFR regulatory guidelines, Outlines of Production and Special Outlines.… more
