- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The qualified candidate will provide knowledge-based coordination, authoring, and management of Dose Preparation Instructions in support of clinical studies ... Collaboration with external stakeholders (eg, research pharmacists, clinical study partner management ) may also be required. Additionally, the candidate will also… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …support the optimization of calibration frequencies through a calibration interval management program including minimally invasive instrumentation tasks which ... Responsibilities Provides technical expertise in support of an effective calibration program that supports daily clinical production and strategically prepares for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …quality and/or timelines at the study level and escalates issues to the DM program lead .- Will manage DM resources of assigned studies; provides FSP/Vendor ... and immune disorders. Summar y : The Manager, Data Management is accountable for end-to-end delivery of clinical data...determines and coordinates mitigation activities; escalates issues to DM Program Lead as needed.- Attends study team… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …role is responsible for developing and implementing effective congress and speaker program strategies and plans to elevate our engagement, corporate presence and ... Functions Strategy, Planning, Performance and Tracking Elevate Portfolio congress, speaker program and market development strategy, plans and execution aligning with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …communications. They will develop and implement a comprehensive strategy for agency management , lead portfolio promotional materials management and drive ... more patients than ever before. The Position The Rare Disease Marketing Operations Lead is responsible for assisting the Rare Disease Commercial Strategy & Marketing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Oncology and Specialty Medicine portfolios, in alignment with the business strategy Lead the DSG inspection management activities by ensuring continued ... leadership teams to ensure Quality is consistently and proactively represented at program level and support proactive quality risk management process.Interact… more
- Formation Bio (New York, NY)
- …faster and more efficiently.About the PositionWe are seeking an Associate Director, Program Management to drive the execution of critical drug development ... cross-functional coordination and execution.As a key member of the Program Management team, you will be responsible...cross-functional teams in a matrixed environment. Partner with the Program Leader to support and/or co- lead the… more
- Formation Bio (New York, NY)
- …with colleagues throughout the company, including our Medical/R&D, Biometrics, Clinical Program Management , and Clinical Operations teams to help identify ... patients faster and more efficiently. About the PositionAs a Lead Product Manager, you will help execute on our...you will see that as an opportunity to innovate!Product Management at Formation Bio is very solutions-oriented and entrepreneurial.… more
- Merck & Co. (Rahway, NJ)
- …role, you will be part of the HHDDA Commercial Data Solutions team and lead Digital Product Management capabilities role, driving shaping and delivery of ... teams to enable use cases across the HHDDA portfolio. In addition, you will also lead a team of highly talented individuals working on multiple data products and use… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Teams.Responsibilities: Study Strategy: Provides the strategic direction to Biostatistics Data Management & Data Ops for EDC, edit checks, data quality listings, ... SAP, Data Management plan; Reviews patient population and protocol compliance for...regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before database lock and quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Clinical Development processes. Job Description:Execute an overarching safety program tailored for AEs from end-to-end: understanding predisposing non-clinical ... and clinical factors, diagnosis, effective management during clinical trials and beyond in post approval...KEE's for advice on complex patient safety issues. Communications lead with HCP's (PI's, sub- PI's, nurses) at the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Support Anticipates problems and roadblocks to avoid crisis management Project Management and Quantitative analysis skills Ability to lead and influence ... Finance, Market Access, Legal, and Compliance to establish and monitor the program operations and related forecasts for affordability programs. Works with key… more
- Merck & Co. (Rahway, NJ)
- …Reporting directly to the Biologics Drug Substance Commercialization Leader, you will lead the Cell Banking working groups and drive innovation in biologics DS ... innovate, iterate, and problem-solve.Cross-Functional Collaboration:-Unite diverse teams to achieve program goals as One Team. Champion compliance and safety;… more
- Merck & Co. (Rahway, NJ)
- …coordinates, and provides biostatistical support for drug projects under the supervision of management .- Lead a team of staff assigned to the project as ... of statistical methodology, experimental design, computing software and data management ; a general understanding of worldwide regulatory requirements; and with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …engagements, strategies, and execution. Essential Functions Brand/Therapy Area Management : Define and execute KOL-related brand/therapy area strategic objectives, ... areas (TAs) and segmentation to inform actionable plans. KOL Experience Strategy: Lead the development and execution of KOL experience strategies and ensure… more
- Merck & Co. (Rahway, NJ)
- …out-of-specification approval, change management approval, etc.Support the Quality Program Lead on inter-departmental and cross-functional teams, ensuring ... regulations and our Company procedures. They will also collaborate with the Quality Program Lead to issue reports summarizing results, works with area to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Novo Nordisk requirements in relation to Pharmacovigilance (PV) oversight and deviations management . This role fulfills the PV Oversight function in PV deviation ... management processes, as well as providing SME-level input from...health authority regulations Develops comprehensive, relevant resources (eg training program , FAQs) to enable compliance with Deviation process requirements… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Novo Nordisk US Operations (USO) AI Center of Excellence (AI CoE). The individual will lead and manage a team of data and AI engineers and developers and is tasked ... with and manages various vendors. Essential Functions Leadership and Management Skilled communicator and collaborator with influence across functions Strong… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and engage internal and external partners to create a curriculum for growth o Lead the functional resource planning process across EI on an annual basis. Partner ... EI initiatives including but not limited to the annual promotions cycle. Lead and support EI initiatives and special projects o Develop innovative solutions… more
- Merck & Co. (Rahway, NJ)
- …Medical Devices, Mentoring Staff, Ophthalmology, Pathophysiology, People Leadership, Physiology, Program Management , Regulatory Affairs Compliance {+ 4 ... performance in a dynamic environment, leaning into areas of talent management and succession planning, operational efficiency and compliance, and external… more
