- Novo Nordisk Inc. (Plainsboro, NJ)
- …for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead Support investigator meetings Serve on Clinical ... on insights from the marketplace. This role may also lead the Core Medical Team, Project Team (co-chair), and...Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director, and Field Medical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Finance & Operations department brings insights and intelligence to inform decision making & drives digitalization and business solutions to ... attain NNI goals. Finance & Operations works closely across the organization to guide enterprise-wide...vendors, serving as the primary point of contact and lead negotiator. Engage internal stakeholders in negotiation decisions. Orchestrate… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …company initiatives and functions such as Marketing, IT, Clinical , Research, Operations , Patient Support Programs, and Digital Health Lead cross functional ... Share specialized knowledge and insights to enhance the team's overall capabilities Lead by example in demonstrating best practices and ethical standards in legal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …interacts with senior leaders across all areas of Novo Nordisk US Operations (USO), including USO President/Executive Office, Commercial, Market Access and Public ... Affairs, Legal, Finance and Investor Relations, Clinical , Medical and Regulatory, plus other cross functional teams...response strategy and public responses Serves as Media Relations lead for USO Crisis Response Teams (CRTs), as required… more
- Formation Bio (New York, NY)
- …to high standards of quality, cost control, and on-time deliverables. Serve as the Operations Lead for clinical assets and associated studies. Step in ... nursing, pharmacy, or a related field. Minimum of 10 years of clinical project management/ clinical operations experience, including at least 5 years in a… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …design. + Pharmaceutical portfolio experience across teams, collaborating with Clinical Operations , Cost Management, Finance and Procurement functions ... the Senior Director, Clinical Outsourcing, the Senior Manager, Clinical Outsourcing will lead and manage the clinical trial outsourcing, vendor selection… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a minimum of 7 years relevant experience required Experience:Experience in global clinical operations methods and processes in industry setting is ... and complete study team list is maintained.In partnership with the lead physician, Clinical Scientist and all study team members, accountable for the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Operations Process Trainer will be responsible for performing training activities for Operations team members who support cGMP Clinical and Commercial Cell ... the treatment of multiple myeloma.Legend Biotech is seeking an Operations Process Trainer as part of the Technical ...This individual will support organization build and ramp-up of clinical production and facility approval of a state of… more
- Formation Bio (New York, NY)
- …medical input into our Business Development product assessment strategy and execution, lead the development of the Clinical Development Strategy and Plans, ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …as the Quality Lead in support of cell therapy manufacturing and operations within the United States.Provide leadership and build an exceptional team to manage ... management system, including providing guidance and direction for transitioning from clinical to commercial phase GMP operations .Partners with other internal… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role ... OverviewThe QA Investigation Lead is an exempt level position reporting to the...and audits as needed.Support compliance activities for site Quality Operations in accordance with Legend standards, procedures and cGMPs.Collaborate… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …operating procedures and batch records and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead the daily start of shift ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Operations Supervisor as part of the Technical Operations team based in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead III as part of the Quality team based in Raritan, NJ. Role ... OverviewThe QA Investigations Lead is responsible for providing quality oversight over the...production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Process Trainer will be responsible for performing process training activities for Operations team members who support cGMP Clinical and Commercial Cell ... coaches and delivers a holistic, effective process qualification program for Operations trainees who support daily clinical production and strategically… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryDirector, Global QA Strategy & Operations (Global R&D PV QA) is responsible for providing strategic leadership ... QA and the Head of Global QA Strategy and Operations to ensure alignment and execution of global initiatives....promotion of the 6th Mid-Term Strategy for Global QA, lead the execution of the business plan, and manage… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Supply Chain Lead will be part of the Manufacturing Technical Operations team responsible for leading Supply Chain planning, inclusive of Production Planning & ... site. This individual will partner with the plant leadership team, various Technical Operations and Quality functions to support both clinical and commercial… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to build upon DSI's foundational training curriculum by developing advance market and clinical training. Lead the evolution of the advanced training curriculum ... technology aligns with all market dynamic internal customers, and local market needs. Lead the development and day-to-day operations of post foundational and… more
- Formation Bio (New York, NY)
- …the General Counsel, but will include extensive cross functional work with business, operations , and clinical /CMC teams and could grow to include management of ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking Facility Support Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe CAR-T Facility Support Manager ... is at an exempt level working within the Technical Operations team. This individual will be responsible for managing facility maintenance activities, including… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …activities involving but not limited to supplier qualification program, CMC audit, clinical /IMP vendor audits and overall GMP vendor audit program. Establish lessons ... continuous improvement in collaboration with other QA functions and/or applicable stakeholders. Support/ lead and or co lead due- diligence assessments of GMP… more
