- Merck & Co. (Rahway, NJ)
- …areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety , Process Development, Technical Services, Utilities and Validation.-The ... Project Design Manager (PDM) Associate Director will lead project teams thru...Estimating and Controls) and externally with Site Operations, Global Safety and Environment and Quality partners.During early phases of… more
- Merck & Co. (Rahway, NJ)
- …highly motivated candidate to join our team as a Pilot-Scale Operations Lab Manager . This role involves managing, organizing, and providing support to the laboratory ... the use and maintenance of equipment.Ensure compliance with appropriate safety standards and Good Laboratory Practice (GLP) guidelines.Required Behaviors:Demonstrate… more
- Merck & Co. (Rahway, NJ)
- …enable and accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable ... of Company policy. The Executive Director will be a manager of managers, with keen focus on coaching and...guidance and quality standards related to product release and safety .NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy -… more
- Merck & Co. (Rahway, NJ)
- …it will be to maintain all equipment in accordance with GMP and Safety requirements, as well as exercising Reliability Maintenance best practices to ensure timely ... related sterile experience.Required Experience and Skills:-Familiarity with Quality, cGMP, Safety & Environmental Policies and Procedures.Technical writing validation documents,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …veterans and people with disabilities. Summary This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership ... with Clinical Safety Scientist Product Lead, Product Safety Lead...Lead and PSL - May serve as a project manager for other activities involving assigned product(s) or clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … manager . Uses medical knowledge to aid the SMT's signal identification efforts. Safety Expert - Signal Evaluation: Assists manager in assessing new signals. ... centered around rare diseases and immune disorders. SummaryThis position supports safety monitoring and risk management activities, provides insights on current… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations. This position develops SAE Flow Plans and electronic data capture ... (EDC) Safety report outputs, reviews clinical study protocols and the...and the Clinical Study Oversight Plan,day-to-day management of DS Safety Notification Letter (SNL) System and manages uploads to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key internal and external ... abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery role, reporting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Project Management Office and Business Excellence (PMOBE) sub-function within Clinical Safety and Pharmacovigilance (CSPV). PMOBE is the strategic planning and ... within CSPV that partners with various stakeholders across the organization. The Manager of PMOBE supports CSPV projects and business process optimizations and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... o 21 CRF 11: Electronic Records, Electronic Signatures o 21 CFR 312.32: IND Safety Reports o FDA Guidance for Clinical Investigators, Sponsors, and IRBs - Adverse… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for the pivotal studies, Integrated Summary of Efficacy (ISE)/Integrated Summary of Safety (ISS) for oncology submission compounds, and expedite the preparation of ... regulatory submissions. Responsibilities include: review Case Report Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and support data review, review analysis dataset specifications and ensure correct… more
- Catalent (New York, NY)
- …as assigned.The Candidate Proven, successful track record as sales executive or brand manager in a leading company operating in the cosmetic industry, minimum 3 ... a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and...of our recruitment and on-boarding processes to maintain everyone's safety . The Human Resources teams will communicate all necessary… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma. Legend Biotech is seeking a Warehouse Operations Manager as part of the Technical Operations team based in Raritan. Role Overview ... The Warehouse Operations Manager will work within Technical Operations and be responsible...security requirements. Develop solutions to enhance quality, efficiency, capacity, safety and security. Participate in or coordinate projects that… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview ... The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...simultaneously Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements. Drive continuous… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(AESI) educational materials. This role works cross-functionally to collect / update safety and treatment information that is ultimately provided to educate patients ... or consulting experience. required and- Prior work experience as a project manager , project lead, or similar role within pharmaceutical drug development desirable.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …as needed to help the team, in a manner consistent with safety policies, quality systems, and cGMP requirements. Support manufacturing investigations, create/revise ... forms, and support and manage change controls. Work closely with Operations Manager to help oversee the development of production personnel, provide input on… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …SOP's and WI's. Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Immediately alerts supervisor/ manager ... when data discrepancies are identified. Job duties performed may occasionally require exposure to and handling of biological materials and hazardous chemicals. Requirements Bachelor's degree in science, Engineering or equivalent technical discipline is… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for the investigations management system. Working closely with the Quality Senior Manager , this position will ensure alignment with all applicable regulations and ... investigations based on potential impact on product quality, patient safety , and regulatory compliance. Address recurring deviations and health authorities'… more
- Penske Truck Leasing (South Plainfield, NJ)
- …continuing to grow your skills from learn from other experienced techs and your manager . Why is this job awesome? For starters, your skills and experience are ... the time you need to do the job right. Safety and reliability are our top priorities. Yes, we...all work adhering to DOT, OSHA, and all Penske safety and maintenance policies; including but not limited to… more
- FlexStaff (New York, NY)
- …the plan of careMaintains constant vigilance over patients care to ensure that safety precautions/needs are followed. (Side rails up, call lights and bedside stand ... Physician during treatments and/or diagnostic procedures;Keeps the Patient Care Manager /designee and/or physician, abreast of changes in patient's condition and/or… more
