- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Employee Engagement Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewJoin our dynamic team at Legend ... New Jersey! We are looking for a dedicated and action-oriented Employee Engagement Manager to lead our engagement initiatives. In this newly created role, you will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and quality. Responsibilities include: contribute to CRF and SDTM standard development , support develop, implement, and maintain Analysis Data Model (ADaM) dataset ... reporting of clinical trials. preferred- Having knowledge of all phases of drug development , including early and late phase clinical development and submission… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Commissioning and Qualification Project Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position ... systems within cell therapy manufacturing. The Commissioning and Qualification Project Manager will develop and manage all aspects of the qualification program… 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)
- …areas centered around rare diseases and immune disorders. Summary: The District Manager (DM) represents Daiichi-Sankyo to assigned customers. The DM hires, leads, ... individual strengths and needs within the District.Maintains awareness of the development of employees within the District by working closely with employees… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking an Investigations Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Manager of CAR-T ... will lead a team to support manufacturing investigations, capacity planning, hiring, development , and performance management of its direct reports.Monitor day to day… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …are meeting DSI supply needs across the entire product portfolio.ResponsibilitiesManage the development of all packaging plans for CMO's based on forecast and ... current inventory levels across all product portfolios. Manage the creation of production plans for finished goods. Analyze inventory trends and procure bulk drugs and finished goods. Coordinate efforts with CMO partners throughout the supply chain to achieve… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Summary:The Associate Director, Oncology Value & Market Dynamics Training Manager is responsible for developing & deploying a strategic training plan ... and workshops. In addition, the Associate Director will be involved in the development /training of field teams for future launch products and expanded indications,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.Drug Development Strategy: Provides input ... with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to… 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)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence ... archive. Bring issues with the reconciliation to the attention of the Study Manager and propose remediation plan.Distribute key study documents to the CRO and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure high quality of laboratory data deliverables to support drug development processes and global submissions. This position provides leadership within Data ... ensures quality delivery of laboratory data for clinical trials, clinical development , and regulatory submissions. This position develops and proposes strategies for… 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
- 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 set the direction for the entire organization. The Position The Senior Manager US Operations Strategy supports in the development and implementation of ... across functional areas Support assessment of initiatives and participate in development efforts, eg strategies, pre-analysis, proposals, business cases Support … more
- Merck & Co. (Rahway, NJ)
- …GCS Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the business. Working ... independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for...GCS and serves as the GCS spokesperson at clinical development related meetings (ie, Clinical Trial Teams) and product… more
- Merck & Co. (Rahway, NJ)
- …GCS Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the business. The Program ... Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS...serves as the lead GCS spokesperson at clinical and development related meetings.- Working independently, the Program CSPM designs… more
- Merck & Co. (Rahway, NJ)
- …The GCS Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the business. -This role ... Management Section of the GCS Planning organization.- Working independently, the Inventory Manager Clinical Supplies Project Manager (IM CSPM) creates strategic… 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
