- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summar y : The Manager , Data Management is accountable for end-to-end delivery of clinical data management ... partners to ensure high quality deliverables are on time to support drug development processes and global submissions. This position also partners with internal and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …key stakeholders within CSPV and external functions including Clinical Development , Research Development , Regulatory Affairs.Facilitate operational meetings with ... monitor performance of vendors against service level and KPIs.Manage the development of governance, business continuity, quality, and vendor monitoring plans.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance, GCP/Document Audits supports end-to-end audit activities ... eQMS in a timely manner.Support CAPA completion for all outsourced audits with Development and Medical QA, PV QA, QMS and stakeholders.Collaborate with QMS Team and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) ... Affairs and cross-functional teams (eg, Quality, CSPV, Clinical Operations, Clinical Development , RA CMC) to keep processes, procedural documents and supporting job… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and execution through RBQM activities. Accountable for the management, performance, and development , both technical and career, of direct reports, and mentors or ... acts as functional manager of skip-level or ex-US staff. This position requires...sites. Additionally, this position possesses adequate knowledge of drug development in pharmaceutical industry across different disease areas, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …some complexity. This position makes decisions with consultation. Responsibilities:Planning for Development : Manages multiple CMC development projects. Leads ... Leads US FDA/EU EMA interactions with support from higher-level manager .Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory guidances. Serves… more
- Aequor (New Brunswick, NJ)
- Position: PROJ MGT - Project Manager -Business Capability Duration: 6 Months Location: Candidates must work 50% onsite at New Brunswick. Local candidates highly ... Collaborate with IT BPs, DCMs & Portfolio Managers on business case development for DC investments, translating PM experience & insights into improved estimates… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …production schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development , and ... performance management of staff in a growing operation in terms of volume/output and team size.Responsible for multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics; these metrics will… more
- Merck & Co. (Rahway, NJ)
- …to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our products. The ... planning, risk assessment strategies and will focus on talent development and partnering to build an integrated culture of...of Company policy. The Executive Director will be a manager of managers, with keen focus on coaching and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …records, forms, and support and manage change controls.Work closely with Operations Manager to help oversee the development of production personnel, provide ... first point of contact for operators on the production floor.Support the development of manufacturing processes, participate in various department projects, and will… more
- Formation Bio (New York, NY)
- …and AI driven pharma company differentiated by radically more efficient drug development . Advancements in AI and drug discovery are creating more candidate drugs ... cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new...and more efficiently. About the PositionAs a Lead Product Manager , you will help execute on our tech strategy… more
- Tris Pharma (Monmouth Junction, NJ)
- …a leading privately-owned US biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, ... Jersey, Tris has an immediate opening for a SR. Manager or Manager , Quality Management Systems (QMS). Title commensurate with experience.Summary:This position… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to providing medical education and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps us all marching to the ... same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs 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… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you in? Are you ready to experiment with us? The Position The Senior Manager Health Care Professional Marketing will be responsible for supporting the development ... requirements. Essential Functions Brand/Therapy Area Management o Support the development and execution of pre-launch, launch, and ongoing HCP-related brand/therapy… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health outcomes. Are you ready to realize your potential? The Position The Manager - Market Access Insights assesses product and customer performance for all ... groups, contributing to manage markets strategy decisions, and is responsible for development and maintenance of a repository of strategy lessons and best-… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to providing medical education and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps us all marching to the ... roles. Essential Functions Compile and submit responses to FDA communications. MANAGER , THERAPEUTIC AREA: Compile, submit and maintain applications (IND, NDA,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to providing medical education and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps us all marching to the ... root cause analysis utilizing Standard Problem Solving (SPS) methods and strong CAPA development within the NN deviation IT platform Serve as chair of PV Deviation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and benefit from a range of possibilities for professional and personal development . Are you ready? The Position Responsible for leading process, reporting and ... compliance related activities for US Talent Acquisition. Responsible for oversight of master data and data integrity related to US Talent Acquisition. Ensures utilized solutions are compliant with regulatory requirement and advises on the same. Ensures Talent… more
- Merck & Co. (Rahway, NJ)
- …Project Managers in Value & Implementation (which is this job), Development , and CMC; Discovery Portfolio Managers; Alliance Managers; Project Management Office ... Director, GPAM, the core responsibility of this Value and Implementation Project Manager role will be direct management of Project Managers, including understanding… more
- Merck & Co. (Rahway, NJ)
- …Sciences (BARDS), a distinguished department within our renowned Research and Development division, quantitative scientists, in partnership with other subject matter ... art scientific methodologies and tools to enable the discovery, development , regulatory approval, manufacturing, and marketing of medical drugs...and maintaining high performing teams both as a direct manager and a second line manager (ie,… more
