- Aequor (Thousand Oaks, CA)
- …of regulations as it relates to case intake and processing Providing audit /inspection support for case management related activities Undertake activities ... call invite to come Schedule - flexible, normal shift Title (Role) Case Management - Senior Manager Organization Global Patient Safety Ideal candidate: BS 8&plus YOE… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary Leads the development and management of DSI's local and global Strategic PV Partnerships and contracts including ... and proactively drive operational excellence and continuous improvement. Oversees the management of Global PV Regulatory Intelligence (PVRI) and dissemination across… more
- Eisai, Inc (Nutley, NJ)
- …want to 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Analyze the data files for completeness and reasonableness before processing. Audit information against payroll register, collaborate with HR/Workday IT resources to ... leave; balance, reconcile and submit payrolls for check processing, audit against payroll register, coordinate with departments on questionable data/corrections.-… more
- Novo Nordisk Inc. (WA)
- …integrity; regulatory and process compliance) for all monitoring and site management activities. Takes ownership to deliver upon near-term North America Clinical ... planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and tools; executes activities relevant to all visit… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …crafting meaningful reports, leveraging data analytics, and supporting project management activities across the legal department. Relationships Reports to Lead, ... government agencies, and business entities. Essential Functions Legal Billing Management Manage the end-to-end legal billing process, including invoice review… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. Summary This position is accountable for comprehensive Payroll Management with a focus on Systems and Process Enhancements/Innovation and relies ... on deep expertise in payroll management , leadership skills, meticulous attention to detail and ability...that these advancements result in more effective and efficient audit responses. Tax Reporting and Compliance Innovation: Oversee and… more
- Eisai, Inc (Raleigh, NC)
- …requirements. This includes reviewing batch documentation and investigating deviations.Process Management : Assist in managing the entire transfer process, including ... Studies, Protocols/Reports, PPQ, PAI Readiness, and Quality System Oversight Implementation. Audit and Compliance: Maintain audit readiness, support regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and industry best practices.Ensure /support the development of GLP/GCLP systems, risk management processes such as SOPs for QA activities for internal and external ... and regulatory authority submissions (IMPD/IND) Responsible to design the audit framework globally for Research area, specifically GLP/GCLP studies.Partners with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …programs, in order to proactively perform safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and ... PSL(s) to proactively plan and prioritize safety surveillance and risk management activities for assigned product(s), including resource planning, oversees team's… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Legal & Corporate Affairs (LCA) including but not limited to: Vendor/Budget Management , Records Management , Litigation, Corporate Governance and other areas as ... must be able to prioritize workflow including the independent management of completing time sensitive complex work and ...annual and quarterly reviews and assist with the yearly audit by external vendor. Frequent contact and coordination with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …safety reporting regulations, Health Canada regulations ICH guidelines and the management of contracts with safety reporting requirements. Key contact person for ... Safety Assessment activities through product development, product maintenance and lifecycle management Ensure Signal Management processes and activities are… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …emerging technologies and trends in the areas to provide informatics project management , SDLC Quality Model, subject matter, and computer system validation guidance ... and operational risks while ensuring these systems are inspection and audit ready. Overall accountability, ensuring higher quality project outcomes with optimal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as the principal functional expert and advisor for implementation and ongoing management and maintenance of the Company's global HRIS system (ie, SAP ... strong commitment to data security and privacy.Implement processes to regularly test, audit and validate HR data to maintain high data quality standards.Conduct… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network Manages Phase 1 - ... eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse events)- May participate in Site Initiation Visit… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network, Manages Phase 1 - ... questions and answers safety questions (dose modifications, discontinuations, and management of adverse events)May participate in Site Initiation Visit (SIV)… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …programs. The CPM will be responsible for all aspects of clinical project management for a trial(s) in our portfolio which includes programs in MASH, cardiomyopathy, ... recruitment materials Oversee the Trial Master File (TMF) and assist with periodic audit of the TMF Drive critical clinical trial activities including trial site… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …gas (GHG) and other ESG Metrics reporting and accounting. Working with management from each US affiliate promote awareness and support the global Corporate ... company's human rights policy, and support data collection for global health management and access to healthcare programs. Develop e-learning and other educational… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …environmentLearn new skills, procedures and processes as assigned by management and continue to develop professionally.Support investigation efforts as ... required.Responsible for audit preparation and participation.RequirementsHS Diploma required with 3 - 5 Years Biotech/Pharmaceutical experience or equivalent… more
- Crown Health Care Laundry Services (Stokes Bridge, SC)
- …ensure effective, safe and cost efficient operations and effective staff management for various departments within the plant. DUTIES AND RESPONSIBILITIES ESSENTIAL ... the Safety Director immediately. Participate willingly in the quarterly safety audit . 7. Track and communicate necessary information to employees regarding… more
