- Merck & Co. (Rahway, NJ)
- …Intellectual Property (IP) organization. Primary responsibilities are to oversee the Trademark Operations team , including operations and workflow; partner ... include but are not limited to:Actively participate as member of the Trademark Operations team to accomplish established goals and meet all deadlinesAccurately… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …myeloma.Legend Biotech is seeking an Operations Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe CAR-T Operations ... Manager is an exempt level position working within Technical Operations . This individual will be responsible for overseeing the production of a personalized cell… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Data Management Plan, and dictionary coding synonym list. Coordinate with Data Operations Team on coding dictionary set up, registration of dictionaries, ... disciplines and cultures. This position requires a demonstrated ability to manage/ lead people and a variety of projects concurrently. Additionally, this position… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and ... of systems development for global informatics systems, ETL and integrations. The Tech Lead must develop and implement informatics systems and programs to support the… more
- Merck & Co. (Rahway, NJ)
- …and scientific rigor for a team of 8-10 scientists. Our BAR&D GMP Operations team validates analytical methods and performs release and stability testing for ... and wellness.Responsibilities include, but are not limited to, the following: Lead a team of scientists to conduct...tests within specified windows for the North American GMP Operations team .Ensure inspection readiness and offer prompt… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …multiple myeloma.Legend Biotech is seeking Training Coordinator as part of the Technical Operations team based in Raritan, New Jersey. Role OverviewThe Training ... coordination of technical training related programs for Raritan CAR-T Manufacturing team members who support cGMP Clinical and Commercial Cell Therapy Manufacturing.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …multiple myeloma.Legend Biotech is seeking Metrology Supervisor as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be ... of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This individual will support organization… more
- Merck & Co. (Rahway, NJ)
- …across HHDDA and our partners across the Globe. - Specifically, the HHDDA Shared Services Lead will:-- Shared Services Team Lead Serve as people manager to ... Digital Data & Analytics Organization Serve as a Global Team Lead to OpEx Pune Hub, AP...ensure a smooth alignment with Shared Services Manage day-to-day operations of the HHDDA Shared Services team … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Key areas of focus will include digital communications/resource development with the operations team , IME status/vendor follow up, program timeline management, ... outcomes and learner insights analysis with our outcomes lead .Additionally, we have a project next summer that will be underway for the build of a new request portal… more
- Merck & Co. (Rahway, NJ)
- …and best practices related to clinical supply planning and incorporate them into the team 's operations . - Focus on Customers & Patients. - Make rapid, ... external to Global Clinical Supply and serves as the lead Global Clinical Supply spokesperson at clinical and development...in a particular area of expertise. - Mentors new team members and supports staff development, as needed Demonstrates… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …myeloma.Legend Biotech is seeking Senior Project Manager, PMO as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be ... of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. The individual will be responsible for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking an Asset Reliability Engineer as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Asset / Reliability ... deployed and maintained following necessary GMP requirements. This person will be the lead for equipment optimizations as well as system upgrades with the systems… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …myeloma.Legend Biotech is seeking a QA Shop Floor Supervisor as part of the Quality Operations team based in Raritan, New Jersey. Role OverviewThe QA Shop Floor ... , Quality Control, Information Technology, Maintenance, Manufacturing personnel, Technical Operations personnel, Human Resources, Site Leadership Team members,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …inspections in the US, in collaboration with the Global RD/PV QA team .RESPONSIBLITIESProgram oversight: Support the Global Quality Lead (s) (GQLs) and Regional ... assigned programs and in close collaboration with R&D Quality team members to ensure that the organization is in...perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality Leads (RQLs), who are… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, and ... trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …has both leadership and management responsibilities and is considered a global leader for a therapeutic area or a large program in CSPV ... organization.ResponsibiliteLeading efficiently and successfully a team of physicians and scientists, accountable for safety surveillance and risk management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of new and updated Core Data Sheets, EU and US Documentation: As the project lead , Independently or through direction of a team of GLLs, manage, develop prepare ... oversight of a team of GLLs, prepare labeling documents for review. Lead review processes to ensure appropriate review and governance by Daiichi Sankyo, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of new and updated Core Data Sheets, EU and US Documentation: As the project lead , Independently or through direction of a team of GLLs, manage, develop prepare ... oversight of a team of GLLs, prepare labeling documents for review. Lead review processes to ensure appropriate review and governance by Daiichi Sankyo, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …visits (expectations of staff contact, ISF review, IP review, SDV/SDR, etc.)Establish and lead the Sponsor Oversight Visit process. Provide oversight of the DS Trip ... CRO CRA monitoring oversight and share findings with appropriate stakeholders/ team leadership.Collaborate on the development of monitoring plan templates including… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and accuracy of payments. Specifically, this role will be accountable for operations , suggest and collaborate with Financial Disbursement team members and ... disorders. Summary This position is a key member of the Financial Disbursements team , reporting to the Head of Financial Disbursements, that manages the day-to-day… more
