- Merck & Co. (Rahway, NJ)
- …regulatory agencies and/or subsidiaries with regard to global regulatory strategy/ registration requirements for one or more our company's investigational and ... programs and marketed products.Review and provide final approval of local registration study protocols when needed to obtain marketing authorization in secondary… more
- Catalent (St. Petersburg, FL)
- …Method Validation, Bulk Mfg Protocol and Reports (non-GMP, Clinical, Registration , Process Validation, Product Transfer, etc.), Risk Assessment, Formulation Reports, ... and effectiveness checks.Bulk Mfg Protocols and Reports (non-GMP, Clinical, Registration , Process Validation, Product Transfer)Master Batch Records; and Master… more
- Merck & Co. (Rahway, NJ)
- …from an internationally or nationally recognized university, along with active registration , in good standing, with a state bar.Required Experience and Skills: ... and change of name recordal projects.Experience in copyright counseling, registration , and licensing.Excellent communication and legal drafting skills; strong work… more
- City of Spring Hill Kansas (Spring Hill, KS)
- …Bachelor's degree in Civil Engineering or a related field required Professional Engineer registration in the State of Kansas required or registration in another ... state with the State of Kansas registration required within one year of hiring Master's degree in Business or Public Administration desired Nine years of similar or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulatory strategy and provide input on IVDR requirements to enable and support timely registration of both therapeutic and diagnostic products in the EU as well as ... of relevant drug and diagnostic regulations on the development and registration activities for the respective medical productsContribute to shared learning forums,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and drives the strategy for all Regulatory activities associated with the registration and support of new and approved drug products.Seeks and incorporate regional ... and functional RA strategy into a global strategy.Responsible for ensuring aligned global regulatory strategy is endorsed by GPT and other governance bodies.Serve as a leader of the GRT (Global Regulatory Team)The primary point of contact with Alliance… more
- Merck & Co. (Rahway, NJ)
- …clinical pharmacology and pharmacometrics of oncology drugs from post-PCC to registration .Associate Directors are emerging leaders in the field of quantitative drug ... development, with a developing understanding of the strategic elements of drug development and effective communication skills. As a subject matter expert, the Associate Director within the Group will work closely with teams of highly collaborative,… more
- Merck & Co. (North Wales, PA)
- …the planning and execution of strategies for drug / vaccine product registration and commercialization / life-cycle management (can be R&D, manufacturing or ... commercial perspective), with demonstrated ability to translate knowledge and expertise to other development teams and areas.Preferred Experience and SkillsAdvanced scientific degree (Master of Science (MS),-Master of Business Administration (MBA),-PharmD,… more
- Merck & Co. (Rahway, NJ)
- …the planning and execution of strategies for drug / vaccine product registration and commercialization / life-cycle management (can be R&D and/or manufacturing) with ... demonstrated ability to translate knowledge and expertise to other teams and areas.-External engagement in project management / pharma-related networks/organizations.-#EligibleforERP NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job… more
- Lundbeck (Bothell, WA)
- …are required for potency methods that will ultimately contribute to our registration packages. This role will interact with Lundbeck Seattle Upstream, Downstream, ... Formulation, and Quality Control groups so strong interpersonal skills will be beneficial. ESSENTIAL FUNCTIONS Develop strategy for potency assays including justification for design of assay and link to mechanism of action (MOA) Develop, optimize and qualify… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …global team in charge of a global clinical program designed to support registration and develop value-enhancing life-cycle strategy. The GTL is the GPT Leader, ... directly accountable for conceiving, designing and implementing product development strategy and delivery for their asset(s). The GTL has end-to-end single point of accountability over the lifecycle of the compound. Acting as "CEO of the molecule", the GTL has… more
- BioAgilytix (Durham, NC)
- …for complex or unique issues and challenges regarding registration and compliance activitiesReviews, interprets, and communicates FDA/international regulations ... and guidance documents to ensure complete and scientifically sound product submissionsPrepare pre-market submission reports / technical files / clinical trial applications per the requirements of key regulatory agenciesCoordinates regulatory issue resolution… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Manage deviations resulting from the US sales force including registration , investigation and implementation of corrective actions Quality Assurance: Provides ... secondary support to all NN GxP Support processes, including but not limited to ISOtrain, Document Control, and/or Audits and Inspections, as necessary Physical Requirements 10-20% overnight travel required. Qualifications Bachelors degree required; relevant… more
- Merck & Co. (Rahway, NJ)
- …Area strategy that will bring forth programs to successful approval and registration .Lead late-stage development for our company's assets in this TA by overseeing ... Product Development Teams (PDTs) and collaborating with Section Heads, PDT Leaders, and Clinical Directors responsible for the design and medical monitoring of clinical studies.Ensure optimal design and monitoring of clinical programs and studies, producing… more
- Eisai, Inc (Nutley, NJ)
- …Regulatory processes such as Submissions Management, Labelling, Publishing and Registration tracking; Working with Regulatory Planners, Publishers, Safety Officers, ... Case Processers, Medical Writers, Labelling authors and study teams; Supporting Safety processes, such as Case in-take, Case processing, Risk management and Safety reporting; Business Intelligence technologies such as Tableau, Spotfire, Business Objects; SaaS,… more
- Hawkeye Community College (Waterloo, IA)
- …of course offering to best suit student needs. Facilitates recruitment, registration , enrollment, and retention of students. Prepares and/or reviews reports that ... provide guidance for student programming. Oversees the curriculum development and assessment process. Manages partnerships with schools and institutions to provide streamlined education resulting in efficient pathways for Hawkeye's students. Partners with… more
- Colorado Housing and Finance Authority (CO)
- …for Single Family loans daily. Performs assignments out of Mortgage Electronic Registration System (MERS) on all loans in a delinquency and bankruptcy status ... and provides backup to MERS system. Monitor the advance and repayment of funds advanced to the sub-servicer for loans in loss mitigation, which includes partial claims and foreclosure claims. Monitor receipt of all loan modification documents to ensure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Pharmacology and Modeling & Simulation plans from FIH to post registration . Responsibilities include the development of Clinical Pharmacology and Modeling and ... Simulation plans, design and lead study teams to execute Clinical Pharmacology studies, conduct hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and Pharmacometrics/… more
- Insmed Incorporated (Bridgewater, NJ)
- …impurity safety assessment in support of CMC manufacturing and/or registration . Contribute to department SOPs and best practice documents.QualificationsDVM, Ph.D., ... or equivalent in Toxicology or a related discipline. DABT/DACVP certification preferred.Minimum of 10 years of experience as a regulatory toxicologist (study director/monitor and/or project lead) in the pharmaceutical or biotechnology industry or within a… more
- State College Domino's Pizza (State College, PA)
- …vehicle to make deliveries) Driver's License (Required)Vehicle Registration (Required)Auto Insurance (Required)Valid InspectionResponsibilities include (but are ... not limited to) Interact with customers in a professional mannerWork days, nights, and weekendsDrive in inclement weatherFollow direction Cleaning of store and equipment as neededDeliver products from the store to customers in your personal vehicleMaintain… more
