- Genmab (NJ)
- …us!The RoleThe Senior Manager, Clinical Programming is responsible for the establishment, governance , and integrity of Study Data Tabulation Model (SDTM) ... programming activities on the Biometrics vendor, ensure the quality and consistency of data standards to support the portfolio towards the ultimate objective of … more
- Insmed Incorporated (NJ)
- …and integrity of all reviewed materials. By driving process excellence, governance , and cross-functional collaboration, you will support timely, compliant, and ... in local adaptations.Develop, maintain, and enforce SOPs, work instructions, and governance frameworks related to the medical review of scientific and… more
- Cipla (Fall River, MA)
- …quality assurance, procurement etc. Act as the custodian of the project governance process. Responsible for stage-gate reviews and escalation of topics, as required. ... project milestones and stage gate reviews. Lead and/or participate in conducting data and hypothesis driven investigations for quality events (planned and unplanned… more
- Genmab (NJ)
- …us!Overview:The Director, Feasibility Lead, will drive the implementation of strategic, data -driven feasibility practices that optimize the design and delivery of ... feasibility approaches and standards by incorporating internal and external data sources, novel technologies, and evolving regulatory and business needs.Mentor… more
- Aequor (Aliquippa, PA)
- …fluent in Smartsheet and Excel, and capable of managing high-volume data with precision and accountability. This individual demonstrates structured problem-solving ... receiving documentation, ensuring accurate execution of GMP processes, records, and data entry. Support and execute the on-site operations strategy in partnership… more
- Merck & Co. (Rahway, NJ)
- …teams and provide functional area point of view in governance interactions.Build alignment across stakeholders with diverse technical backgrounds, priorities, ... to clinical endpoints.Working knowledge of biomarker platforms and multi-modal data integration (eg, immunoassays, flow/immune profiling, NGS, omics) with effective… more
- Insmed Incorporated (NJ)
- …as needed, the Executive Committee and Board of Directors.Establish and maintain governance frameworks and control structures consistent with NIST and FDA data ... across Insmed's technology landscape and protect sensitive patient and research data .Demonstrated experience leading a Computer Systems Validation team in a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Global Medical Omnichannel capabilitiesDigital KEE/DOL engagement strategies and capabilitiesAdvanced data and analytics including oversight of deployed data ... digital projects of mutual interestRepresent GOMA on internal digital governance committeesChange management/SMEContinuously monitor the external landscape to identify… more
- Repligen (Waltham, MA)
- …of ITGCs across Logical Access, Change Management, System Operations, and IT Governance .Conduct IT application control reviews for key systems (eg, SAP, Tagetik, ... improvements, automation opportunities, and standardization across ITGC and SOX processes.Utilize data analytics to enhance testing quality, reduce risk, and improve… more
- Merck & Co. (Durham, NC)
- …monitoring of systems and ensure returns are being achieved. Report on and run governance meetings to manage the program, solicit help and ensure targets are met. ... and key performance indicators. Benchmark performance indicators against industry data . Look for continuous improvements opportunities RESOURCE MANAGEMENT: Forecasts… more
