- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the development of the clinical study plan including critical path activities and interdependencies for assigned clinical stud(ies) utilizing Microsoft Project or ... and manage the overall implementation and documentation of the CSOP including activities conducted by CROs and vendors.Provide operational input into study protocol… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for the delivery and execution of the Global R&D QA strategy, activities , and deliverables against the R&D Oncology and Specialty Medicine strategic priorities, ... in internal and external cross-functional meetings or other relevant activities .Support the External Partner Quality Lead(s) (EPQLs), who are responsible… more
- Genmab (NJ)
- …Management is operationally responsible for the oversight of Clinical Data Management activities related to the effective planning, and timely delivery of complete, ... objectives and areas for development of Clinical OperationsEnsures data management activities and processes support the efficient and effective execution of clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(RPM) provides planning and drives coordination of global and US regulatory activities . The Associate Director RPM is responsible for supporting the global ... lead (USRL) and global regulatory team (GRT) for assigned projects and activities to achieve regulatory milestones and deliverables successfully and in a timely… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …HCP Relationship Management, ensuring compliance HCP Fee for service activities , leading speaker training initiatives, management of non-HCP promotional programs, ... may advise Global Teams with regard to speaker selection for global activities if requested. External relationships include those with speakers (including key… more
- Merck & Co. (Rahway, NJ)
- …for vaccines and biologics. CCFS supports various commercialization activities , second generation process development including process characterization, technology ... partners, this individual will support late stage and commercial large molecule program activities within CCFS. The individual will be responsible for leading a team… more
- Merck & Co. (Rahway, NJ)
- …group of subject matter experts who facilitate all organizational and strategic activities within the department. These activities include developing and ... developing, executing, and monitoring strategies for supply and commercialization activities .Ensure organizational alignment and coordinate the establishment of execution… more
- Merck & Co. (Rahway, NJ)
- …operational experience to support facility operations, process development activities , compliance investigations/change management, and authoring of GMP ... Prepare for and support batch processing readiness and execution activities .Prepare, review, and/or approve GMP Documentation as appropriate.Author/Approve Standard… more
- Merck & Co. (Rahway, NJ)
- …operational experience to support facility operations, process development activities , compliance investigations/change management, authoring of GMP documentation, ... to: Prepare for and support batch processing readiness and execution activities . Prepare, review, and/or approve GMP Documentation as appropriate. Author/Approve… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Functions Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others Leads process and equipment troubleshooting on the ... practices Coordinate fabrication, procurement, installation, engineering start-up, and validation activities of new equipment and systems Lead the development and… more
- Merck & Co. (Durham, NC)
- …Laboratory Manager leads a team of analysts in the start-up and method transfer activities to develop BCG and future testing capability at the Durham site.-- The ... laboratories for microbiological testing and environmental monitoring.- Method transfer activities will include qualification of equipment, facility and utilities.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …applicable policies and procedures, and the development and execution of monitoring activities that are outlined in the various study/CRO plans across the ... escalation pathways are present.Support monitoring process checks linked with CRA activities that require inclusion in the quality plan.Responsible for monitoring… more
- City of Spring Hill Kansas (Spring Hill, KS)
- …managerial, and professional duties in planning, coordinating, and directing the activities of the Police Department. Provides effective leadership ensuring the ... and submits periodic reports to the City Administrator regarding the Departments activities . Attends conferences and meetings to keep abreast of current trends in… more
- Insmed Incorporated (San Diego, CA)
- …with team members in the review and development of Data Management activities including data cleaning, eCRFs, edit checks, report development, and database lock ... processesParticipate in activities related to data review, database lock, medical monitoring,...revision of departmental and corporate SOPs and processesSupport regulatory activities at the protocol level to develop, prepare and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …n/a Essential Functions Product manufacturing and product manufacturing support activities Completion of routine documentation associated with the manufacture of ... product Support in-process activities and product development when instructed by supervisor Incorporate pre-planned process improvements/cost reduction program into… more
- Merck & Co. (North Wales, PA)
- …patients and global human health.This position supports statistical programming activities for multiple and/or late stage drug/vaccine clinical development projects. ... contact and knowledge holder through the entire product lifecycle. Primary Activities :Effective analysis and report programming development and validation utilizing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …closure of deviations, Quality investigations and CAPA's related to operational activities .Ensure good CAPA effectiveness checks to keep standards on day-to-day ... activities and avoid recurrences.Take accountability for best practices as...Legend Biotech policies and GXP requirements.Ensure compliance of operational activities with GXP, quality, training, EHS, security requirements.Develop solutions… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Water for Injection (WFI) sampling in support of cGMP manufacturing activities associated with sterile manufacturing. Job Responsibilities The Microbiologist is ... Water (RO), and Clean Steam to support manufacturing and/or qualification activities . Perform Personnel Monitoring of sterile garbed personnel.Perform Compressed Air… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …issues Coordinate fabrication, procurement, installation, engineering start-up, and validation activities of new equipment and systems, including documentation of ... fabrication, installation and validation Point person for process improvement activities , including performing or authoring equipment specifications, user and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …us? The Position This position supports rebate processing and business assurance activities under Rebate Operations & Assurance. Ensures timely and accurate payment ... accurately and that payments are issued as expected Ensures that all activities meet internal and/or external service level agreements and Sarbox controls Maintains… more
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