- Insmed Incorporated (Bridgewater, NJ)
- …for Millennials™ lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of Pharmacovigilance QA ... serves as a strategic partner managing quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and other related activities performed by… more
- Insmed Incorporated (Bridgewater, NJ)
- …in New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance, the Director , Quality ... QC oversight activities for Insmed. He/she will be responsible for Quality related activities for commercial products including transition from development (Phase… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Oversees management and performance of CRO. Occasional interactions with CRO senior leadership as needed; Participates in creation of developmental and regulatory ... studies: Provides the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and protocol compliance for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and quality metrics and share with study team, Operations Program Lead, and Sr . Director for the compound, on regular basis and ensure actions are taken ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Oversees management and performance of CRO. Occasional interactions with CRO senior leadership as needed; Participates in creation of developmental and regulatory ... MM review of data for safety (with CSPV) and quality at project levelStudy Strategy: For Phase 2 and...Develops biomarker strategy in collaboration with TMCP, Collaborates with external KOLs to refine study plans; Prepares and participate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and quality metrics and share with study team, Operations Program Lead, and Sr . Director for the compound, on regular basis and ensure actions are taken ... Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …needs and the respective development stage of the project. The CMC Lead will support the Sr . CMC Lead on complex and/or late-stage project or act as main CMC Lead of ... smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ideally including time in role such as a Global Project Leader at Sr . Director level or equivalent preferred- Relevant therapeutic experience and proven ... areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head has leadership and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …responsible for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) ... clinical study physicians and physician scientists as well as external investigators is expectedThe CS Group Lead will also...CS Group Lead will also ensure the writing of high- quality clinical trial protocols, review of clinical data and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for ... Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director of Field Medical Excellence (FME) will develop field medical functional ... strategy to enable high- quality , impactful customer engagements with a consistent approach worldwide....customer engagements with a consistent approach worldwide. The FME Director will also drive operational excellence across the regions.… more
- J&J Family of Companies (Skillman, NJ)
- Sr . Director , External Quality - 2307013581W **Description** Kenvue is currently recruiting for: Sr Director , External Quality This role ... waiting for you! Join us in shaping our future-and yours. What You Will Do The Sr Director , External Quality encompasses the end to end oversight of NA… more
- Terumo Medical Corporation (Somerset, NJ)
- …**Job Summary** The Senior Manager-Indirect Tax will collaborate closely with the Senior Tax Director of Terumo Americas Holding (TAH) and its subsidiaries ... Sr . Manager, Indirect Tax Date: May 6, 2024...regulatory requirements and mitigate potential risks. + Keep the Senior Tax Director apprised of all Indirect… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …from quality , clinical compliance, regulatory, formulations, and IOPS (CMC, external manufacturing, stability). **A typical day might include the following:** + ... The ** Sr Manager, Clinical Drug Supply & Logistics** is...are performed on time, within budget and with good quality , in compliance with Regulatory Authorities' regulations / guidelines… more
- IQVIA (Bridgewater, NJ)
- …deployed to maximize account coverage. + Interacts regularly with internal and external senior executives. **Required Qualifications** + Bachelor's Degree + 8+ ... to announce that currently we are looking for a ** Sr . Director of Client Services** to join...+ Develops budget and reviews analyses of activities, costs, quality , operations, and forecast data to determine department progress… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Oversees management and performance of CRO. Occasional interactions with CRO senior leadership as needed; Participates in creation of developmental and regulatory ... studies: Provides the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and protocol compliance for… more
- J&J Family of Companies (Raritan, NJ)
- Senior Director , Portfolio and Operations - 2406189153W **Description** Johnson and Johnson is currently recruiting for a ** Senior Director , Portfolio ... interpersonal skills for effectively collaborating with partners at various levels, including senior executives, board members and external partners. + A solid… more
- Bausch Health (Bridgewater, NJ)
- …(CTM), Senior Clinical Research Associates and Clinical Research Associates ( Sr . CRAs and CRAs) and Clinical Trial Assistants (CTA).. **Responsibilities** + ... study objectives are being met and provide the operations director and/or senior management with timely updates...communication of any variances to budget forecast to the Sr . Director or Director of… more
- Hormel Foods (Bedminster, NJ)
- …subsidiary of Hormel Foods in July 2015. **RESPONSIBLITIES:** Reporting directly to the Sr Director of Innovation & Brand Equity, the Creative Director ... APPLEGATE FARMS** Founded in 1987, Applegate Farms, LLC produces high- quality natural and organic hot dogs, bacon, sausages, deli...related field). + 10 years experience as an Art Director / SR Graphic Designer in a… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …needs and the respective development stage of the project. The CMC Lead will support the Sr . CMC Lead on complex and/or late-stage project or act as main CMC Lead of ... smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior… more
