- Merck & Co. (Rahway, NJ)
- …animal species. About the Position The Animal Health IT Customer Master Data Management (MDM) Product Owner collaborates with stakeholders across all levels of ... organization, from senior management to tactical execution- to understand customer master data management needs. With an increased focus on Commercial, Sales, and… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of… more
- Merck & Co. (Rahway, NJ)
- …in public disclosure of clinical trials and their results, document disclosure, and data sharing with external researchers. The Executive Director in Medical ... Writing will be responsible for overseeing clinical trial data registration, results postings, redaction operations, external data sharing, and authoring lay… more
- Merck & Co. (Rahway, NJ)
- …background in analytical methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and ... accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for… more
- Merck & Co. (Rahway, NJ)
- …solve problems, sound scientific understanding of Critical Quality Attributes and Quality by Design principles, and advanced data analysis for drug ... Job DescriptionThe Director of Biologics Potency in Analytical Research &...to GxP laboratories.- He/she will be responsible for managing quality science and effective prioritization to bring analytical representation… more
- Merck & Co. (Rahway, NJ)
- …Template asset, delivering enterprise-level capabilities through harmonized business processes and data .-The team is responsible for the operation of all our ... and overall role administration. This role reports to Executive Director , SAP Platform Team. Primary Responsibilities: Leadership and StrategyProvide strategic… more
- Merck & Co. (Rahway, NJ)
- …helping to solve vital business needs for Finance by leveraging data analytics and understanding implications on global healthcare systems. Audit assignments ... working intimately with our global business operations.-In addition, individuals will use data analytics to gain insights into business practices and the execution… more
- Merck & Co. (Rahway, NJ)
- …to audit to the relevant requirements.Under the direction of the Audit Director and the Auditor-in-Charge ("AIC"), the Specialist will:Participate in the execution ... (including walkthroughs and sample testing) in line with the established quality standards and timelines.Maintain the highest standards of professionalism and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary Director , Global Medical Affairs Oncology Publications works with Cross Functional Team ... research organizations, and study investigatorsManage vendor budget and activitiesOversee the quality and timeline of vendor workCollaborate with study medical lead… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …investigators is expected. The CS Group Lead will also ensure the writing of high- quality clinical trial protocols, review of clinical data and Clinical Study ... multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science...of ICF, DM charter, response assessment charter, etc), clinical data review excellence with a focus on patient safety… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: The Associate Director of Regulatory Writing is a key role responsible for producing scientifically ... accurate, high- quality clinical regulatory documents while adhering to regulatory guidelines....strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director of ERP Applications is responsible for overseeing and enhancing designated ... from all Daiichi Sankyo regions in scope.- Responsible for developing high quality solutions based on Functional Design documents. Perform system customization and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, ... and executing post-approval Regulatory CMC strategies, reviewing CMC information and data , authoring CMC submissions, and interacting with Health Authorities to meet… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review teams as well as with business partners to achieve high quality and accurate labeling in support of business objectives.ResponsibilitiesPreparation of new and ... updated Core Data Sheets, EU and US Documentation: As the project...Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes Process Best Practices: Serve as a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global ... Statistical Programming Management: Coordinates outsourced statistical programming of analysis data sets and tables, listings, and figures (TLFs) needed for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol ... to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Phase 2 studies: Provides the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and protocol ... to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Phase 2 studies: Provides the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and protocol ... to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with… more
- Eisai, Inc (Nutley, NJ)
- …and make a difference. If this is your profile, we want to hear from you. Director , Global RWE & Data Science sought by a pharmaceutical company in Nutley, ... NJ. Assess real-world data gaps and lead evidence generation process for the...that address issues such as payer challenges, impairments in quality of life and patient well-being, and gaps in… more
