- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …up to date with the latest methodologies and insights. Relationships Reports to the SR Director Sales Reporting & GtN. Internal relationships include Senior ... the presenting, messaging, reporting and analytics of sales results to company senior management. The position is responsible for: Proactively and cooperatively with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Act), and within defined budgeting guidance). Relationships Reports to the Executive Director OED. Accountable for managing relationships with external partners ... a collaborative work culture, including direct partnership with the Operations Director (s) Stakeholder management: Build strong internal and external … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …while testing new/future opportunities. Relationships This position reports into the Sr . Director , Omnichannel Engagement and is responsible for managing ... ensure optimization of the database platform, patient acquisition and audience quality Establishes and enforces governance procedures to ensure CRM operational… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …trends of Novo Nordisk and competitor products that impact the volume outlook to senior leadership in a clear & consistent fashion. This position plays a critical ... development of the volume forecasting environment while leveraging internal and external resources as appropriate. Relationships Reports to the Executive Director… more
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory agencies. Supervise designated personnel. Relationships Report to the Director /Associate Director /Lead Regulatory Scientist/ Sr . Manager Regulatory ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …data sharing, non-disclosure, and master service agreements across a broad spectrum of external entities with a focus on budget, quality , compliance and in ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to assist with overflow in other areas as needed. Relationships Reports to a Manager, Senior Manager, Associate Director or Director . Works with personnel in ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… 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
- Amicus Therapeutics (Princeton, NJ)
- Associate Director , External Quality Lead (Small Molecule) Location Princeton, NJ Requisition ID 2258 # of openings 1 Apply Now ... (https://phh.tbe.taleo.net/phh04/ats/careers/v2/applyRequisition?org=AMICUS&cws=37&rid=1303) Associate Director , External Quality Lead (Small Molecule)… 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
