- Novo Nordisk Inc. (Plainsboro, NJ)
- … Data Science and Evidence (CDSE) Real World Evidence (RWE) team. Relationships The Senior Manager reports directly to a Senior Director within the CDSE ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Eisai, Inc (Nutley, NJ)
- …on system validation. Support computer system audits for review of SDLC and data integrity controls. Review CAPA and verification of CAPAs of system audits. Support ... Requirements Bachelor's degree in associated functional disciplines including IT, Data Sciences and others.Software development familiarity with both Agile and… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Study Manager - Epidemiology OperationsSupport the Lead Epi Scientists by providing overall operational support for ... of collection, international shipment, processing by internal/external labs and data transfer for biospecimen- based studiesParticipate in quality … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the Biostatistics ... and Data Management team and performs programming tasks, including SDTM...collaborating with CROs and other vendors to ensure high quality deliverables to support drug development processes and global… 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 ... key Daiichi Sankyo regulatory systems. This includes defining regulatory data standards, data quality rules...role will need to partner closely with teams and senior leaders from across Regulatory Affairs, as well as… more
- Merck & Co. (North Wales, PA)
- …and related study materials (eg, ICF documents/amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection in ... collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and integrity of… 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 ... protocol development, CRF review, SAP development, analysis files development, data surveillance review, statistical analysis accuracy validation, results interpretation… more
- Merck & Co. (Rahway, NJ)
- …solutions using Agile methodologies.Collaborate with systems engineers, software engineers, data services, architecture, test engineers, and operation engineers to ... market and/or user research, feedback, expert opinion, and usage data to understand needs and opportunities.Prioritize product and service requirements,… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining ... Novo Nordisk cloud platforms are being used in a secure and quality -oriented manner. Solving ad-hoc technical challenges together with end-users and dedicated teams… more
- Novo Nordisk Inc. (Durham, NC)
- …technology & processes in accordance with relevant project plans & timelines. Relationships Senior Manager , Quality Control - OFP. Essential Functions ... life-changing careers, and the opportunity to help improve the quality of life for millions of people around the...Accuracy & Scientific Soundness of Lab Data Environmental Compliance GMP Compliance of Laboratory Maintain testing… more
- Aequor (Thousand Oaks, CA)
- …stakeholder perspectives Strong analytical and Project Management ability with an eye for data quality Ability to develop and effectively present to executive ... and Commercial to understand corporate and functional prioritization approaches and data sources to support PD prioritization Organizational and business change… 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
- Merck & Co. (Rahway, NJ)
- …of the SDLC, excellent communication and collaboration skills, and a focus on quality and customer satisfaction.The Release Manager is responsible for the ... Global Template asset, delivering enterprise-level capabilities through harmonized business processes and data .- The team is responsible for the operation of all our… more
- BioAgilytix (Durham, NC)
- …deviations, and CAPA's, when appropriate, under the supervision of the Manager , Sample ManagementEnacts process improvementsEnsures data integrity and ... the work of team members under the oversight of senior managementSupervises the professional development of direct reportsConducts performance reviewsCoaches… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …site. Relocation assistance is available for selected candidate. Relationships Reports to: Senior Manager - Facilities Engineering & Metrology. Number of ... and Quality groups) related to commissioning and validation Provide data for assessments associated with change control activities Review protocols, summary… more
- Merck & Co. (Rahway, NJ)
- …- Prepare clinical narratives - Collaborate cross-functionally to monitor clinical study data to ensure quality , completeness, and integrity of trial conduct. ... close out of clinical trials within a program.-Clinical trials provide the required data which allows Merck to bring new prescription medications and vaccines to the… more
- Novo Nordisk Inc. (Durham, NC)
- …engineering teams & stakeholders, management of vendor & service contracts. Relationships Manager or Senior Manager . Essential Functions Lead reliability ... life-changing careers, and the opportunity to help improve the quality of life for millions of people around the...and implement process and programs to enhance reliability of data entered to support reliability and maintenance excellence programs… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything ... n/a Essential Functions Business Partnering: Act as Business Support Project Manager for strategic projects & implementation Drive improvement initiatives at both… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. Summary The Global Team Leader, is a senior , cross-functional leader in Daiichi Sankyo's Global R&D organization. At Daiichi Sankyo, ... plans, and addressing all regulatory, drug and patient safety, data , CMC, IP, patient selection, market acesss and and...Execution and delivery of strategic plans with speed and high- quality . Ensuring that creative, innovative as well as practical… more
