- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, ... and sections of submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This individual is a member of the Development and Medical Affairs QA leadership team and maybe extended member of the global RD/PV QA leadership team . ... strategic initiatives in close collaboration with cross functional leadership team (ie, OBU, SBU) and study teams to uphold...REMS, co-partners and affiliates. Liaise with Audit and Compliance team to ensure that Global Medical Affairs audits are… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and integrity.This position reports to the Head, Global QMS (RD PV QA) and is a member of the leadership team .Lead an enterprise cross-functional QA team to ... and drives process improvements. Collaborating with the Global QMS eCompliance team , the director oversees QA plans, promotes data governance, and engages… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CMC project representative to the CMC sub team and the RA team and serves as ad hoc member to the Global Project Team for late stage projects. This ... preparation of the briefing book, to training and preparing the technical team , to authoring and finalizing the meeting minutes. This position develops awareness… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of strategic priorities, resources allocation and capability elevation. As an integral member of the Leadership team , the position will closely collaborate ... and management of the newly created TA Oncology Leadership team and in driving strategy, management and facilitation of...tactical initiatives under the guidance of the TA Leadership team and in partnership with members of the RD… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking an Operations Supervisor as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe CAR-T Operations Supervisor is an exempt ... level position working within Technical Operations team , responsible for directing the daily production of a personalized cell therapy to support both clinical and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …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 ... maintain strong relationships with key internal stakeholders, including the site leadership team , people leaders, and HR Business Partners, to deliver programs and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …during CDx Indication Team Working Group (WG) cross-functional meetings. Serve as member of the Joint Project Team (JPT) with the Diagnostic (Dx) Partner ... (PoC) for gathering country/region specific CDx RA requirements from local RA team members (eg from Japan, China, Australia, Canada, Korea etc.)For recruitment in… more
- Merck & Co. (Rahway, NJ)
- …Regulatory Affairs, Procurement, and suppliers. Key Functions Work Independently and as a Team member with Integrity - Precision - Accomplishment - Motivational ... The Senior Engineer in Device Technology is a key member of our Device Development & Technology Team... member of our Device Development & Technology Team , with responsibilities supporting the commercialization and sustainmentof medical… more
- Tris Pharma (Monmouth Junction, NJ)
- …a successful business and take pride in the company's success. Equally importance to each team member is how we interact with one another on a daily basis. ... categories.Our science and technology make us unique, but our team members set us apart; they are the engine...open and honest communications to help support individual and team success.We have an opening in the Generics division… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …agenda and assist in management of monthly meetings. Maintain Outlook GPM&L member lists. Coordinate and attend GPM&L team building activities.Directly support ... more efficient ways of working within GPM&L or on a project team , enhanced collaboration tools, etc.Schedule and implement on-site/off-site & virtual meetings, (eg,… more
- Tris Pharma (Monmouth Junction, NJ)
- …a successful business and take pride in the company's success. Equally importance to each team member is how we interact with one another on a daily basis. ... technology.Our science and technology make us unique, but our team members set us apart; they are the engine...open and honest communications to help support individual and team success.Located in Monmouth Junction, New Jersey, Tris has… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an Automation & Controls Technician (Contractor) as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be responsible for ... candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.Good written and verbal… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …a Commissioning and Qualification Project Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position is responsible for the ... activities to meet company goals, quality, and regulatory objectives. Qualification team will consist of managing external resources and some internal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Head of Center of Excellence (CoE), Global Medical Safety will oversee a team of safety physicians and scientists across various regions, offering guidance and ... support to each product safety team in critical areas such as individual case medical...strategy and harmonize processes that support the department's objectives.ResponsibilitiesA member of DSI CSPV and Global Medical Safety leadership… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Maintenance Specialist I (1st shift) as part of the Facilities & Engineering team based in Raritan, NJ. Role OverviewThis position will be responsible for ... or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by… more
- Merck & Co. (Rahway, NJ)
- …region and specific area and discuss this with the respective Global process Team member or Regional Commercial IT leads/members. Collaborate with other Global ... Job DescriptionOur IT team operates as a business partner proposing ideas...more productive and enable innovation. Join our innovative IT team at our company, where we leverage technology to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking an Investigations Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Manager of CAR-T Investigations will be ... part of the Operations Investigations team and will be responsible for managing and leading different investigations work-cells, drive investigations to closure,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …programming support to prepare regulatory requested analyses and help submission team in quick turnaround in response to regulatory agencies. Responsibilities ... quick turnaround, support ad-hoc and exploratory analysis requested by clinical team , provide programming supports in agency response or potential Advisory Committee… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Engineer, Technical Support (3rd shift) as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Associate Manufacturing Engineer, Tech ... Support (3rd Shift) will be part of the Technical Support team and be responsible to support the development and routine operation of a new CAR-T manufacturing… more
