- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational planning ... Responsible for clinical program planning and execution (from study design, operational planning, start-up, conduct, reporting, and close out) including timeline,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Director (Sr. Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or ... span all phases of clinical development (pre-clinical to post-licensure). The Senior Director will manage the entire cycle of late-stage clinical development… more
- Merck & Co. (Rahway, NJ)
- …spanning production, utility systems and associated infrastructure .- Responsibilities of the Senior Specialist - Process Supervisor include the following : - - The ... process supervisor role at the Senior Specialist level will serve as an operations team...collaboration, learning and innovation.- - - As MACS becomes operational the MACS Process Supervisor will supervise and participate… more
- Merck & Co. (Millsboro, DE)
- …of vaccines and medicines to address unmet medical needs.- -- Essential functions of Senior Technician : Starting on day one, we will provide you the necessary ... training the Senior Technician will need to follow Good Manufacturing Practices...general maintenance and support functions Anticipates and solves complex production/ operational problems Organizes own time and that of others… more
- Formation Bio (New York, NY)
- …efficiently.About the PositionFormation Bio is seeking a highly skilled and experienced Senior Director, Biostatistics to join our dynamic team. This critical role ... initiatives, and leveraging biostatistics to advance our drug development processes.The Senior Director, Biostatistics will play a key role in shaping innovative… more
- Merck & Co. (Rahway, NJ)
- …and future GMP operationsAccountable for the new drug substance facility Operational Readiness, Strategy and Execution, including leading a matrixed team that ... Inspire, encourage and support scientific excellenceCollate across the BPRD Network Operational Excellences and efficiency projects and partner with teams in driving… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Leadership Develop and execute a robust Continuous Improvement and Operational Excellence strategy aligned with organizational objectives. Champion a DX-DSS-wide ... teams to embrace Lean, Six Sigma, and related methodologies. Partner with senior leadership to identify and prioritize improvement opportunities with the greatest… more
- Merck & Co. (Rahway, NJ)
- …(AIC), the Senior Specialist will:Participate in the execution of financial, operational , SOX 404 and IT audits, integrated audits and process audits, both ... domestic and abroad to maintain a strong internal control environment at our company.On occasion, the incumbent will be expected to lead small teams of auditors audits with limited management supervision in addition to actively performing audit work.Under the… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The Role:The Senior Statistical Manager acts as a biostatistician supporting the clinical development of compounds ... trial result meetings Review and approve the CSR Attend operational and steering committee meetings, as applicableSupport regulatory submission/filing… more
- Merck & Co. (Rahway, NJ)
- …other workstreams' critical activities to enable facility startup and operational readiness.Collaborate closely with the formulation scientists, engineers, quality ... representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ultimately to enable the flexibility and speed of the company's pipeline.Support the formulation, process development, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the US Regulatory PMs assigned to alliance assets for operational matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. ... Lead and prepare FDA submissions, including but not limited to briefing documents, breakthrough therapy designation requests, orphan drug applications and BLA annual reports. Collaborate with all disciplines within the Daiichi Sankyo organization to obtain… more
- Merck & Co. (Rahway, NJ)
- …(Planning) organization is the key interface between clinical development teams and the operational /executional arms within the business. - - This role works with in ... Manager Clinical Supplies Project Manager ( IM CSPM) creates strategic and operational plans associated with the downstream activities of clinical supplies for their… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …choices, drive core operations and develop insights to drive growth and operational excellence across the value chain while innovating for future capabilities. Our ... partner with budget controllers (FP&A) and other key stakeholders across various operational areas. The position will also interact with personnel in Corporate… more
- Merck & Co. (Rahway, NJ)
- …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 all activities associated with clinical supplies for their assigned… more
- Merck & Co. (Rahway, NJ)
- …and mitigates risks across all factors that may impact technical, operational & regulatory success or timelines. -Analyzes and develops innovative solutions ... prioritizing, interrogating and mitigating risks across technical, regulatory and operational factors.- Conducts options analysis and provides recommendation to… more
- Aequor (Thousand Oaks, CA)
- …and Technology) Marketing team to provide project management, marketing, and operational support for marketing and cross functional initiatives - Provide project ... DTC resources, through work with marketers and execution partners - Operational / administrative support: Coordinate meeting logistics and calendars ensuring… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …community relationships, enhance the company's brand & reputation, and secure appropriate operational framework for success. If you are ready to make a difference ... for corporate initiatives Develop tools & methods to reduce communication gaps between senior leadership, managers & shop floor, including Town Hall meetings & other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and prioritizing CoE resources for key programs. The role will also provide senior safety leadership and guidance on complex issues across the DS portfolio, ... within CSPV and other departments across the company to ensure alignment. This senior role will involve close cooperation with other CSPV Leadership to develop… more
- Merck & Co. (Rahway, NJ)
- …IT Research Infrastructure Product Line (RIPL) engineering team is seeking a Senior Specialist - Laboratory IT Engineering.- This position will be a member ... and application platforms directly supporting our Company's Research Laboratories.- The Senior Specialist will collaborate with various IT teams, scientists, and… more
- Merck & Co. (Rahway, NJ)
- …organization is the key interface between clinical development teams and the operational /executional arms within the business.-- - - The Program Clinical Supplies ... related meetings .- Working independently, the Program CSPM designs strategic and operational plans for all clinical supply activities associated with the clinical… more
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