- Aequor (Tampa, FL)
- …Analytics activities related to Market Research and GVP Activities to ensure that internal audits responses, the third-party risk process, and reporting are ... ensure timely closure of Audit activities and continuous monitoring of trendsManage internal vendor onboarding, including Third Party Risk Management (TPRM)… more
- Genmab (NJ)
- …advice and recommendations through interpretation of complex information to influence internal and/or external cross functional contacts. Manage/ lead projects ... to have you join us!The Role & DepartmentThe Feasibility Lead supports the vision and strategy set forth by...in use of data, tools and processes to inform risk -benefit decision making at TA, program and study levels.This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …reconciliation, external data acquisition, validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk ... reconciliation, external data acceptance and reconciliation reports, study data protection, operational metrics, and clinical trial quality and risk management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Engagement and Collaboration:Facilitate effective communication and collaboration with internal stakeholders, including IT and Compliance Risk ... compliance and accountability in data management practices. The position also involves risk -based validation of IT services and determining audit targets for GxP… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational planning and execution of FIH, ... Responsible for clinical program planning and execution (from study design, operational planning, start-up, conduct, reporting, and close out) including timeline,… more
- Repligen (Waltham, MA)
- …an effective internal control framework that spans all global operations. Lead the SOX compliance program, including risk assessments, documentation, testing, ... the SOX program. Shape and execute compliance strategy across a global company Lead SOX risk assessments, audits, and remediation efforts Partner with senior… more
- Repligen (PA)
- …platforms (including Workday and other tools), ensuring integration,data accuracy, and operational scalability. Risk Management & Compliance Monitor and ensure ... OverviewThe Director, Global Payroll will lead the development and execution of Repligen's global payroll strategy tosupport a growing global workforce. This role… more
- Merck & Co. (Rahway, NJ)
- …trust, and inspire accountability Ethical, resilient, and committed to scientific and operational excellence Skilled in risk management, team facilitation, and ... Job Description Lead the Future of Biologics Drug Substance Commercialization!...analysis, and documentation of cell culture process commercialization Drive risk assessments, control strategies, comparability reports, PPQ, and regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and manages risks for the data management function and supports functional risk identification/management efforts globally.Serves as the internal Data Management ... as the Data Management leader representing R&D during regulatory inspections and internal audits pertaining to R&D activities. Operational Efficiency /… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …safety team in critical areas such as individual case medical review, risk management, aggregate safety reports, and translational medical safety. This role requires ... as the organization grows and business needs evolve.Ensure the CoE's continuous operational execution and excellence by applying best practices in accordance with… more
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