- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Global Head of Centre for RWD / RWE (CR2) Project Management and Operational Excellence (PM-OE) will lead innovation, coordination, and strategic planning ... efforts and will be responsible to facilitate continuous improvement and operational excellence for Global CR2 across all the three regions of Japan, Europe and US… more
- Merck & Co. (Millsboro, DE)
- …that appropriate support to site operations is maintained, and that all operational activities are compliant with regulatory, safety , cyber-security, business ... Job DescriptionPosition Description: Associate Director - Site Digital Technology Lead The Site Digital Technology Lead is the representative for Global Animal… more
- Merck & Co. (Boston, MA)
- …notebook entries.Participate in partner site visits to evaluate processes, capabilities, safety procedures and compliance standards as well as build workflows to ... internal company processes.Together with Discovery Operations, manage the scientific and operational relationship between our company and CROs by providing support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including critical path activities ... writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND. Lead the CRO and...budget against trial progress and bring deviations to the Operational program Lead and study team leader.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …direct reports.ResponsibilitiesStudy Management and LeadershipHas primary accountability for operational study-level timeline, cost, and quality deliverables. Lead ... writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND. Lead the CRO and...budget against trial progress and bring deviations to the Operational program Lead and study team leader.… 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. We ... regulate accounting, uphold workplace safety , manage our supply chain and sampling, support technology,...department in development and execution of departmental strategic and operational plans and processes to support the current and… more
- Merck & Co. (Durham, NC)
- …of the HPV vaccine manufacturing process while ensuring compliance with all regulatory and safety guidelines. Lead a diverse team and be accountable for all ... people that make our products. We work in the manufacturing plants with a " Safety First, Quality Always" mindset striving for continuous improvement. We work in the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads ... involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets… 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 ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Represents Clinical Development in Project Teams, possibly as Global Clinical Lead .Responsibilities:Medical Monitoring Planning (MD Only): For large Phase 2 or Phase ... Collaborates with CSPV to ensure monitoring / reporting of AEs/SAEs, Reviews safety reports/data during study conduct, Provides and documents oversight of medical… more
- Merck & Co. (Durham, NC)
- …team members in executing smaller improvement projects in their operational areaRepresent Operations on project teams as neededCommunicationLead and support ... tours to provide area/process overview information to visitors/auditors upon requestQuality & Safety ComplianceFoster strong and effective safety culture on the… more
- Catalent (Harman, WV)
- …that the Harman's site operates. The Manager, Supply Chain - Warehouse will lead a shift consisting of Warehouse Materials Control Associates and Materials Services ... efficiently and partner with other functional leads to improve operational performance and compliance will be a success factor...a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and… more
- Merck & Co. (Rahway, NJ)
- …strategies for investigational drugs and planning clinical trials (design, operational plans, settings) based on these clinical development strategiesMonitoring and ... and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports,… more
- Merck & Co. (Rahway, NJ)
- …as other workstreams' critical activities to enable facility startup and operational readiness.When operations commence, this individual will partner closely with ... in New Jersey and reports to the Sterile Production Lead of the FLEx GMP facility within Pharmaceutical Operations...within Pharmaceutical Operations and Clinical Supply.Once the facility is operational , duties will include but are not limited to… 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 ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …a team-based environment, on an assigned production shift schedule. Key Responsibilities Lead and supervise multiple units within the CAR-T process operations (ie ... records and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead the daily start of shift operations meetings, the daily wrap up… more
- Catalent (Philadelphia, PA)
- …They will have a deep understanding and values around patient and employee safety , will assist in the enforcement of GMPs and regulatory compliance through FDA ... and Catalent requirements, and will provide customer satisfaction and operational efficiency. As a QADC Supervisor, this position requires the individual to ensure… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of the Quality Operations team based in Raritan, New ... Jersey. Role Overview The Quality Systems Lead role is an exempt level position with responsibilities...issues. Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Require minimal… more
- Catalent (Philadelphia, PA)
- …DEA, CDC, and USDA requirements. They will provide customer satisfaction and operational efficiency. This is a full-time position: Monday - Friday, days. Catalent ... Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. The Role: Responsible for… more
- Merck & Co. (North Wales, PA)
- …of internal stakeholder groups including the Outcomes Research and Clinical Safety organizations. Lead and actively contribute to departmental strategic ... stakeholders including Statistics, Clinical Research, Regulatory, Observational Research, Clinical Safety and PK/PD Modeling and Simulation organizations.Primary Activities :Address… more
