- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a QC Data Reviewer as part of the Quality team based in Raritan, NJ. Role Overview The ... QC Data Reviewer is an exempt level position responsible for reviewing...in a controlled GMP environment. Key Responsibilities Perform peer review /approval of laboratory data including but not limited to… more
- BioAgilytix (Boston, MA)
- …QC reviewsFollow QCT SOPsResponsible for second-level technical reviews of documents prior to review by the project manager (eg, Bioanalytical Project Manager ... II/III will perform responsibilities of a traditional lab analyst, peer reviewer , and new system implementation specialist. Tasks will encompass running assays,… more
- Merck & Co. (Millsboro, DE)
- …our systems such as Reliance, Atlas SRM, WorkDay, myLearning, eTime, Inspire.Compose, review , edit institutional SOPs.Serve as the hiring manager and trainer ... training and oversight of the animal care staff, serving as a designated reviewer and voting member of the Institutional Animal Care and Use Committee (IACUC),… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs. Develop and maintain positive rapport and ... roles. Essential Functions Compile and submit responses to FDA communications. MANAGER , THERAPEUTIC AREA: Compile, submit and maintain applications (IND, NDA,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the ... specifications as per CDISC SDTMIG.Perform SAS programming to provide complex data review listings and reports to support Data Management and clinical teams.Develop,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of this job is to oversee statistical vendor deliverables, perform programmatic review of analysis datasets and Table, Listing, and Figures (TLFs) generated by ... By leading internal programming contractor or by self, perform programmatic review of analysis datasets and TLFs generated by statistical vendor, ensure… more
- Lundbeck (Chicago, IL)
- …of growth!Open to candidates anywhere in the greater United StatesSUMMARY:The Senior Manager Sales Training and Development is primarily responsible for managing the ... sales management training needs by observing individual Biopharmaceutical Account Manager performance/behaviors and collaborating with the appropriate functional areas… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Laboratory operations will manage the internal analytical laboratory and ... characterization for drug substance, drug product and reference standards. The Manager must possess a good understanding of pharmaceutical development processes from… more
- Catalent (St. Petersburg, FL)
- …to the QMS.The QA Manager is responsible for the overall Quality Assurance review and approval of all technical documents including but not limited to: a) change ... Manager , QA (Product Development)Position SummaryThe Quality Assurance Department...across the site and with clients to drive timely review , approval, and closure of investigations, change controls, audit… 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
- Novo Nordisk Inc. (Raleigh, NC)
- …with superior ability to lead through change. Relationships Internally, the Educator Manager (EM) reports to a Region Business Director (RBD) in the Commercial ... measures, market updates and insights to ensure teams remain up-to-date Analyze, review and provide monthly report on Educator activities for direct reports to… more
- Novo Nordisk Inc. (Boulder, CO)
- …change. Are you ready to make a difference? The Position The Senior Manager of Specialty Raw Materials Manufacturing is responsible for ensuring a steady supply ... the supply of raw materials, during the execution of his/her duties, the Manager /Senior Manager should seek to actively improve existing manufacturing processes,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) provides planning and ... coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead… more
- Catalent (St. Petersburg, FL)
- …The QA Product Manager is responsible for the overall Quality Assurance review and approval of all technical documents including but not limited to: a) change ... QA Product Manager Position SummaryThe QA Product Manager ...across the site and with clients to drive timely review , approval, and closure of investigations, change controls, audit… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …case processing activities, which include the receipt, documentation, triage, case review , and quality assessment of all inbound safety information, including ... initiatives/activities, social/digital media monitoring services, and Registries incl. contract review and negotiation, with management of SDEA requirements, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... as well as the overall process.Accountable for the maintenance, and peer review of key Daiichi Sankyo procedural documents (SOPs/SOIs), including external data… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …Director of Research Administration and under limited direction, the Contracts Manager - Federal Contracts and Compliance, will oversee end-to-end contract ... contracts and compliance of the Office of Research Contracts (ORC).The Contracts Manager - Federal Contracts and Compliance will work closely with LBRI… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study problems. ResponsibilitiesProtocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, ... medium complexity studies including study design, protocol development, CRF review , SAP development, analysis files development, statistical analysis accuracy… 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 ... archive. Bring issues with the reconciliation to the attention of the Study Manager and propose remediation plan.Distribute key study documents to the CRO and… more
- Catalent (St. Petersburg, FL)
- …to the safety of every patient, consumer and Catalent employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management support ... Document Control, Equipment/Facilities, Change Control, etc. The focus of each QA Manager may be dependent upon the needs of the business and structure… more
