- Legend Biotech USA, Inc. (Raritan, NJ)
- …multiple myeloma.Legend Biotech is seeking QA Document Control Leadas part of the Quality team based in Raritan, NJ. Role OverviewThe QA Document Control Lead ... management process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …is seeking Senior Project Manager, PMO as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be responsible for providing ... operational excellence project management support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will partner with Plant… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …a requirement.Experience directly supervising employees is preferred.Ability to work with and lead others in a team environment.Demonstrated ability to develop ... Shop Floor Supervisor as part of the Quality Operations team based in Raritan, New Jersey. Role OverviewThe QA...the production of personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …product to patients. This individual will be an integral part of the CAR-T Equipment team in support of on-going clinical and commercial manufacturing as well as ... Asset Reliability Engineer as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Asset /...following necessary GMP requirements. This person will be the lead for equipment optimizations as well as system upgrades… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …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 ... the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment.Key ResponsibilitiesThis individual… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking Quality Project Management Specialist as part of the Quality team based in Raritan, NJ. Role OverviewThis position is an exempt level position. ... improvement projects within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution ... lead the development and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of the other sections in… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …leaders, advisory boards, industry councils and the broader medical community. Essential Functions Lead the clinical informatics team in the (CDSE) ... Leadership Team . This individual will provide leadership to the clinical informatics team , mentor and develop individual contributors within the clinical … more
- Genmab (Plainsboro, NJ)
- …seeking an experienced Senior Clinical Drug Supply Manager to join our Global Clinical Drug Supply Operations team .As Senior Clinical Drug Supply Manager ... to drive solutions and inspire others.You will join a highly competent global team focused on packaging and labeling clinical trial supplies, collaborating… more
- Merck & Co. (Rahway, NJ)
- …and ethical standards.-The Distinguished Scientist (Executive Director) and Product Development Team (PDT) lead , Oncology Global Clinical Development, ... the field of breast cancer. The Executive Director, PDT lead will manage the entire cycle of clinical...as well as the ability to function in a team environment, are essential.- Preferred Experience and Skills: Board… 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 ... for ensuring oversight of Central Monitoring activities according to the Clinical Monitoring Plan inclusive of trend identification, impact assessments and creation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... The PositionThe Novo Nordisk Real World Evidence (RWE) / Clinical Data Science & Evidence (CDSE) - Fellow is...coordinate other activities including but not limited to cross-functional team meetings, project team meetings and observational… more
- Merck & Co. (Rahway, NJ)
- …Teams, Clinical Trial Teams, Discovery, Informatics; Diagnostics, quantitative modeling team ; Biostats, Molecular Assay teams, and other key LFs to author ... to the following: Hypothesis-building & strategy forming collaborate with stakeholders in clinical development team (s), to formulate testable clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …external stakeholders on important drug safety issues supporting Global Medical Safety Lead . Responsible for safety governance/oversight of Clinical Safety and ... a large program in CSPV organization.ResponsibiliteLeading efficiently and successfully a team of physicians and scientists, accountable for safety surveillance and… more
- Merck & Co. (Rahway, NJ)
- …including those new to the organization therefore requiring someone who has built and lead clinical development plans from the ground up. They will also be ... responsible for guiding Product Development Team Leaders and Clinical Directors within their group to ensure that their programs are being executed effectively… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Product Evolution Oversee product strategy and regulatory activities related to new clinical data or label changes. Lead modification to marketing strategies ... development efforts in existing and new areas. The STARS team collaborates and partners with groups across NAO, Research...our future. The Position The Rare Bleeding Therapeutic Area Lead is instrumental in shaping and executing NNI's strategic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D ... teams. Motivated, collaborative, and science-driven global safety expert who would lead the ongoing assessment of safety profile of assigned molecules/products and… more
- Merck & Co. (Rahway, NJ)
- …development projects; and assist the Associate Vice-President/Vice-President and product development team lead in ensuring that appropriate corporate personnel ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility...as the ability to work collaboratively in a cross-functional team environmentNOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy… more
