- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the ... Quality organization with One Quality voice as the best trusted quality partner with internal and external stakeholders. The incumbent must aim to… 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 qualitative means. Candidate will define Key Performance Indicators, Key Quality Indicators, Key Risk Indicators, and other targeted operational metrics in ... collaboration with R&D Line Functions. Candidate will establish internal and external benchmarks to inform future planning and target setting. Candidate will oversee… 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)
- …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)
- …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)
- …ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , Clinical Operations on plans for successful ... operational planning, start-up, conduct, reporting, and close out) including timeline, quality , and budget management Drives and leads the successful execution of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Research programs for development of early clinical studies. Provides senior level clinical representation at meetings with health authorities; Leads the ... regulatory strategy; Accountable for performance of CROs; Routine interactions with senior management of CRO, as needed; Accountable for clinical development plans,… 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
- 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
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Senior Quality Engineer at Insmed position reports directly to the ... Director of Product Quality Complaints. The primary... quality and customer satisfaction within the organization.ResponsibilitiesThe Senior Quality Engineer is responsible for managing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …stage) within the Global Clinical Science function. This position may be at the executive director level or senior director level, depending on the scope and ... trials from the clinical science perspective, and ensure the writing of high quality clinical trial protocols, review of clinical data and Clinical Study Reports… more
- Insmed Incorporated (Bridgewater, NJ)
- …documents and training. The Manager, US Compliance reports to the Senior Director , US Compliance.ResponsibilitiesCollaborate with US Compliance Business Partners ... driving projects to completion independently with the utmost integrity.Produces high quality work with minimal oversight from Manager.Possesses a 'can-do' attitude… more
- J&J Family of Companies (Raritan, NJ)
- Sr . Director , Senior Safety Officer- Johnson & Johnson Enterprise Innovation - 2406193938W **Description** Johnson & Johnson, is recruiting for a Senior ... this includes single case signal detection activities for selected products. The Senior Safety Officer (SSO) has responsibility for implementing the safety strategy… more
- J&J Family of Companies (Raritan, NJ)
- …of the Johnson & Johnson Family of Companies, is recruiting for a Director / Senior Director , Clinical Rseearch Physician for **Late Development Oncology** ... Medical Director / Sr . Medical Director ,...execution of oncology clinical research studies, ensuring consistency and quality , across the assigned development program. The successful person… more
- System One (Easton, PA)
- Title: Sr . Director of Information Security Location: Eastern Pennsylvania Schedule: M-F 8am-5pm Hybrid onsite weekly Compensation: 230-265k + bonus, excellent ... to minimize exposure to cyber threats. + Coordinate with internal and external stakeholders to investigate and remediate security breaches. + Conduct post-incident… 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: Jun 4, 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
- Pfizer (Peapack, NJ)
- **ROLE SUMMARY:** Reporting to the Sr . Director , Core Laboratory Services, Unit Management Office (UMO), this position will support the selection and oversight ... for working transversally with all CD & O functions, development, Legal and external parties to execute vendor service agreements; support CD & O teams in… more
- Sanofi Group (Bridgewater, NJ)
- Job Title: ** Senior Director of Business Development, Vaccines** **Location: Swiftwater, PA OR Bridgewater, NJ OR Cambridge, MA** **About the Job:** Ready to ... the world. With the application of business insight and industry knowledge, the Sr . Director of Business Development's key objective is to secure… more
