- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Management (RPM) provides planning and coordination supports for global and US regulatory activities . The Manager 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
- Catalent (San Diego, CA)
- …and sound fiscal responsibility. The primary responsibilities of the Senior QA Manager include activities related to GMP (Good Manufacturing Practices) and ... Senior Manager , Quality AssurancePosition Summary:Catalent Pharma in San Diego,...oversight, quality support to operations and coordination of audit activities affiliated with assigned projects.This is a full-time (on-site)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Clinical Safety Scientist Product Lead and PSL - May serve as a project manager for other activities involving assigned product(s) or clinical studies, as needed ... in support of benefit risk profile throughout product lifecycle Independently leads activities without supervision for assigned clinical studies Lead activities … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and projects. Provides guidance to study team on all aspects of statistical activities ; collaborates closely with data manager to ensure high quality data. ... Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium complexity studies including study design, protocol development,… more
- Catalent (Philadelphia, PA)
- …to the safety of every patient, consumer, and Catalent employee. The Role Support activities of the Manager , Training Program and the Training Lead.Cross train ... with Quality Systems team by supporting activities of the Manager , Quality Systems which may include audit support activities , GMP training and Compliance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CSPV management.Safety Expert - Signal Identification: Carries out routine signal identification activities formulated by manager . Uses medical knowledge to aid ... immune disorders. Summary Position supports safety monitoring and risk management activities , provides insights on current clinical practice and guidelines, reviews… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …alignment with the business needs Acts as IT Operations advocate, coordinating daily activities with the IT Manager (IT Infrastructure Owner) and team members ... Supervisor of IT Operations Direct Reports: None Essential Functions IT Infrastructure Manager , covering GxP and non-GXP systems: Drive and maintain IT Operations… more
- Aequor (Piscataway, NJ)
- Job Title: Manager /Sr. Manager Medical Communications Hybrid schedule: West Chester.PA (hybrid) Is this temp to perm? The manager intends to convert the ... FTE after a year Shift Type: Day M-F 9-5 Position Summary: The Manager /Sr. Manager , Medical Communications (S/MMC) supports publication strategy and plan… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management ... activities pertaining to clinical trials, including but not limited...limited to: All responsibilities of a Senior Clinical Data Manager (SCDM) and a Clinical Data Manager … more
- Merck & Co. (North Wales, PA)
- Job DescriptionOverview:The Associate Director Publication (Pub) Manager is the central source of information regarding publication activities and is responsible ... global publication strategies and tactical plans. The Associate Director Pub Manager oversees compliance with our company's publication policies and procedures and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Clinical Research Manager (aCRM) - Oncology With support of other Clinical Research Manager 's (CRMs) and/or ... Visits Reports and escalates performance issues and training needs to CRA- Manager and/or functional vendor and internal management as needed.o Performs Quality… more
- Merck & Co. (Rahway, NJ)
- …other external data, biomarker data, and clinical outcomes assessments.2. Serves as project manager of all clinical data management activities for trials as ... Job DescriptionThe Trial Manager creates and ensures the successful execution of...with staff across sites, countries, and time zones. Primary activities include but are not limited to: 1. Develops… 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...This role will also provide oversight of technical operations activities including data or document review, risk assessments, CAPAs,… more
- Aequor (Thousand Oaks, CA)
- …identify and drive efficiencies in current and future delivery processes. The Project Manager will coordinate and direct the activities of project team members ... systems), and artificial intelligence experience. Large organization experience. The Project Manager will be accountable for managing one or more high-level, complex… more
- Daiichi Sankyo, Inc. (San Francisco, CA)
- …centered around rare diseases and immune disorders. Summary: The Oncology Territory Manager represents Daiichi Sankyo to assigned customers. The Oncology Territory ... Manager represents the assigned product(s), and their approved indications,...of the products, applications, technical service, market conditions, competitive activities , advertising, and promotional trends through the reading of… more
- Daiichi Sankyo, Inc. (Houston, TX)
- …areas centered around rare diseases and immune disorders. Summary: The Oncology Territory Manager reports to the District Manager and is responsible for ... relationships with the customer and become a resource. Communicate with the District Manager on a regular basis and discuss issues and opportunities. Represent the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(GOMA) Company Sponsored Studies (CSS) and Medical Access/Expanded Access (MAP)/(EAP) activities in adherence to Good Clinical Practices (GCPs), appropriate Standard ... adherence to timelines and clinical milestones of GOMA clinical activities as appropriate.Responsibilities Clinical Operations Study/ Program ManagementCompany Sponsored… more
- Insmed Incorporated (Bridgewater, NJ)
- … Manager , Regulatory Operations will be responsible for functional activities related to US/Ex-US regulatory submissions. In addition, this individual will ... be responsible for general document management activities relating to the archiving of submission and submission related documents in the Company's electronic… more
- Merck & Co. (Durham, NC)
- …several years; currently Durham employs 1,000+ people. This role as a Manager , Operations will be an energetic, leader with strong interpersonal, leadership, and ... Focused areas of responsibility include but are not limited to activities of: Media Preparation, Fermentation, Tangential Flow Filtration, Process Monitoring,… more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems ... approach to drive compliance and assess operational needs and activities in to accurately, effectively, timely and compliantly achieve...(minimum 3 of those years in a supervisory or manager role) Special knowledge or skills needed and/or licenses… more
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