- Aequor (Thousand Oaks, CA)
- …Delivery teams and suppliers Develop and maintain Project Sourcing Plan with Project Manager as a \"living document \" throughout project life cycle Lead ... for signature, and store for compliance. Ideal Capital Projects Sourcing Manager candidate: 5 years hands-on capital construction experience in procurement and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …timeline, budget and objectives set forth by the Study team. The Clinical Study Manager role is primarily a tactical study delivery role, reporting into an Associate ... operational delivery aspects of the protocol and take a document review & coordination role for the protocol and...in accordance with DS standards. Act as the project manager of the clinical study team to liaise and… more
- Merck & Co. (Rahway, NJ)
- …Management activities with the support and oversight of a Senior Clinical Data Manager (SCDM)/Lead Clinical Data Manager (LCDM); issuing queries and follow up ... SCDM/LCDM in the creation and review of Trial Deliverables, document archiving, UAT of Data Bases, External Data activities...operational project assignments under the direction of an Operations Manager (OM). - Your Fellowship Project - - You… more
- Eisai, Inc (Exton, PA)
- …Plant and LabsPartner with Site QA in the GMP validation of Lab automation. Document GMP documentation as per Exton SOPs.Partner with Infrastructure Services and IT ... Security for Infrastructure services such as network support, storage, IT security controls on all Lab PCs.Manage vendor relationships, including escalation.Manage specialized device lifecycle, including onboarding/Offboarding, coordinate the upgrade process… more
- Eisai, Inc (NJ)
- …is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. ... will have proven ability to effectively manage the outsourcing of document preparation when necessary and the associated service providers. Essential Functions… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Study Manager - Epidemiology OperationsSupport the Lead Epi Scientists by providing overall operational support for study ... and validation plansParticipate in protocol and interim/final report preparation, shepherd document through the internal review process for approval, and upload to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical ... by providing input for the interaction or by writing the interaction document . May participate in meeting or teleconferences with Health AuthoritiesGlobal strategy… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities to comply with US, EU, Japan ... and research portal is current.Lead/co-lead global process development and procedural document drafting, as appropriate.If necessary, substitutes for the Director at… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional activities related ... submissions. In addition, this individual will be responsible for general document management activities relating to the archiving of submission and submission… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and 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
- 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 for providing quality oversight for the manufacturing process,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to Company-wide trainings and external/global trainings, as appropriate.Maintain systems and document training curricula to ensure that only current training modules ... of existing policies and procedures.Maintain current and accurate systems for document sharing.Building Relationships -the position is responsible for building 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 ... prescribe data handling, protection, and user provisioning controls- Identify, assess, monitor, document , and communicate potential quality issues in the way data is… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …knowledge and application of measurement uncertaintyAbility to develop, document , and implement new measurement methods and test systems.Demonstrated ... knowledge of programming languages in support of instrument automationGreat time management skills and both the desire and ability to work in fast paced, growing and dynamic environmentAbility to lead a team and manage a calibration program across facilities;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for the authoring and lifecycle management of all GCO-owned procedural document packages, ensuring they are clearly and effectively written and maintained, ... Management:Responsible for the ownership and maintenance of GCO-owned procedural document packages.Lead authoring, review, and periodic reviews/updates for all GCO… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence ... with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile the TMF document trackers generated by the CRO with the document archive.… more
- Shimadzu Scientific Instruments (Washington, DC)
- …technical expertise to the assigned region(s) customers and staff. This document attempts to communicate the traditional, physical and environment demands associated ... and interpretation of results, and report generation. (Daily) Assist the Regional Manager as necessary. (Daily) Travel as required, overnight travel can vary by… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …performance and other areas. You will report to the Manager , Microbiology.Job ResponsibilitiesProvide general oversight, plan, organize, direct, and evaluate ... systems.Knowledge of quality systems including exception management, change control, document control.Knowledge of operating and troubleshooting procedures for lab… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …forms, and support and manage change controls. Work closely with Operations Manager to help oversee the development of production personnel, provide input on ... work in job environment with physical dexterity sufficient to use computers and document production records A working leader who can participate in production runs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …analyses execution, quality control, and data derivation; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical ... by providing input for the interaction or by writing the interaction document . May participate in meeting or teleconferences with Health Authorities Qualifications:… more
