- Merck & Co. (Rahway, NJ)
- …stakeholder expectations; facilitation of cross-functional decisions.3. Defines trial-level requirements for quality data collection and validation at the trial ... data , and clinical outcomes assessments.2. Serves as project manager of all clinical data management activities...protocol specific data validation elements).4. Manages trial-level data quality and completion of database lock… 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 ... not limited to: All responsibilities of a Senior Clinical Data Manager (SCDM) and a Clinical ...output.Accept and execute special responsibilities related to process maintenance, data quality assessment, staff training and mentoring… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory ... across key Daiichi Sankyo regulatory systems. This includes defining regulatory data standards, data quality rules and data governance processes across… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …management of data at Daiichi Sankyo including: the stewardship organization, data quality , metadata management, lineage capabilities and the data ... areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work...including advocating for good data governance, stewardship, data identification, and data quality … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Provides guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data . Work ... closely with internal statistical programmer.Drug Development Strategy: Provides input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and… more
- Tris Pharma (Monmouth Junction, NJ)
- …knowledge or skills needed and/or licenses or certificates preferredCertified Quality Manager , Engineer or AuditorExperience with drug-device combination ... Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Order process, bid defense meetings, and selection of vendors. Provide support to Study Data Manager with all invoice approvals if/when applicable. Serve as a ... on behalf of Daiichi Sankyo. This position also ensures quality delivery of all 3rd party data ...team as an extended part of committee. Advise Study Data Manager on complex vendor management issues… more
- Eisai, Inc (Nutley, NJ)
- …Plan and monitors study conduct to proactively address issues to ensure high quality study data (as needed).Clinical Study Report - provides statistical and ... your profile, we want to hear from you. Job Summary The Senior Manager , Translational Science Biostatistics will be expected to work independently with minimal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....difference? The Position The CMR Business Planning & Strategy Manager will be responsible for facilitating the creation and… 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 for ... global publication strategies and tactical plans. The Associate Director Pub Manager oversees compliance with our company's publication policies and procedures and… 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...is an exempt level position with responsibilities for providing quality oversight for the manufacturing process, equipment, and associated… more
- Aequor (Thousand Oaks, CA)
- …systems), and artificial intelligence experience. Large organization experience. The Project Manager will be accountable for managing one or more high-level, complex ... projects to delivery specified requirements. This includes ensuring timely and quality delivery and comms around innovative content pilots designed to optimize,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… 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. (Ames, IA)
- …team takes a customer centric perspective using customer feedback and market intelligence data . Using this data , we design, develop and deploy products, ... to aid in delivery of product to customers, ie International Registration, Quality Control, Quality Assurance, Production, etc.Provide Sales force training as… more
- Eisai, Inc (Nutley, NJ)
- …Safety staff for all marketed and investigational Eisai productsDesigns and conducts quality reviews to verify the accuracy, completeness and validity of information ... reports, or international regulatory reports and requests. 20%Set standards for data collection and distribution processes; coordinates with others to assure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …analysis dataset in compliance with CDISC and submission requirement, review submission data package and ensure its quality and integrity- Oversee statistical ... and TLFs transfers for ongoing and complete trials, confirm data use and output quality , proactively ensure the resolution of programming related issues prior… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... to experiment with us? The Position The HCP CX Manager will be a critical driver in ensuring the...materials, including coordination with external suppliers and agencies. Ensure quality control of marketing material. Ensure quality … more
- Novo Nordisk Inc. (Durham, NC)
- …duties & QA presence & process confirmation on shop floor. Relationships Manager , Quality Assurance. Essential Functions Ensures site compliance with ... life-changing careers, and the opportunity to help improve the quality of life for millions of people around the...confirmations & Go Look Sees Evaluates trend & report data for QMRs & APR reports Other accountabilities, as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....NNI Patient Safety Group and other departments on Safety Data Exchange Agreement (SDEA) related matters. To contribute and… more
