- Merck & Co. (Rahway, NJ)
- …to become the premier " Data First" commercial biopharma organization.In this Associate Director Data Product Management role, you will be part of the HHDDA ... is a plusTranslate use cases into implementation roadmaps to deliver high quality data productsEstablish common performance expectations and processes for … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director for Cell Based Sciences within Analytical R&D is responsible for providing strategic leadership and partnering with the ... from pre-clinical through clinical development and into commercial supply.The Executive Director reports to the Vice President, Analytical Research & Development and… more
- Formation Bio (New York, NY)
- …to bring new treatments to patients faster and more efficiently.About the PositionThe Director , Quality Management Systems plays a pivotal role in ensuring ... and ICH guidelines. Proven experience in developing, implementing, and managing pharmaceutical quality management systems, including document control,… more
- Merck & Co. (Rahway, NJ)
- …responsible for-ensuring reliability and efficiency of site operations through data -analytics.-This role will-assess current state analytics and collaborate with ... strategy for Rahway-and support the-regional portfolio-.This role will develop a plan to-utilize- data visualization, data analysis, data monitoring and … 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)
- …major focus on outcomes - Work closely with software engineers , UX designers, data engineers, quality engineers and other product teams and product leadership - ... Ability to analyze data to make informed decisions, understand KPIs, user metrics,...planning & tracking tools - Experience working on and managing agile times (scrum, kanban, etc.) - - Preferred… more
- Formation Bio (New York, NY)
- …materials. Proven track record of overseeing quality activities at CDMOs and managing Quality Agreements. Experience developing and managing GMP audit ... to bring new treatments to patients faster and more efficiently.About the PositionThe Sr. Director , GMP Quality Assurance will lead the GMP QA strategy and… more
- Formation Bio (New York, NY)
- …the highest quality standards, with a focus on patient safety, data integrity, and regulatory compliance. Support internal and external audits and regulatory ... bring new treatments to patients faster and more efficiently.About the PositionThe Director of Clinical Trial Management is responsible for leading and overseeing… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full our ... a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines ,- strategies and… more
- Merck & Co. (Rahway, NJ)
- …exploring supply markets for innovative solutions, benchmarking industry practices, managing key suppliers, and employing rigorous sourcing methodologies to ensure ... CSS team with IS&O initiatives and daily operations, adopting high- quality change practices and embodying our Companys Enterprise Leadership Skills.Stakeholder… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of external data -- acceptance, storage, and delivery activities to ensure complete, high- quality data is available for use by clinical study teams in a ... around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides...and other initiatives. Proactively identifies and manages risks to data quality , data integrity, programming… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …be supporting early clinical safety for our Rare Disease/Specialty Medicine portfolio. SummaryThe Director , Clinical Safety, will be a product safety lead or part of ... safety leadership and serving as the primary point of contact.Review and analyze data from clinical trials, post-marketing and other relevant sources for the prompt… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as well as other research areas centered around rare diseases and immune disorders.SummaryThe Director , Clinical Safety, will be a product safety lead or part of a ... safety leadership and serving as the primary point of contact.Review and analyze data from clinical trials, post-marketing and other relevant sources for the prompt… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …related to RBQM CSM to improve quality and ensure patient safety and data quality and integrity.Establish, measure, analyze and report on RBQM CSM related ... position is responsible for implementation and oversight of the Risk Based Quality Management (RBQM) principles that support the Company's vision including elements… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …metrics.Implement and manage robust data governance processes to ensure ongoing data quality and security, facilitate or collaborate in regular audits ... role is responsible for design and overseeing, coordinating, and managing activities related to the ongoing operation of modules...with data governance processes to ensure ongoing data quality and security, supported by regular… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance ... complies with all applicable regulations and guidelines and with Company Core Data Sheets and manages deviations. This position interacts across the RA function… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Chain, Commercial) to evaluate and execute on deal opportunities, including managing the interface with global/regional teams and ensuring alignment with project ... Valuation NPV Modeling Financial Support: - Provide independent and high- quality financial support to all BDL transactions including In-Licensing, Out-licensing,… more
- Merck & Co. (Rahway, NJ)
- …Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications ... for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical… more
- Merck & Co. (Rahway, NJ)
- …of regulatory submissions. -Under the general scientific and administrative direction of Director in the CCFS group and working in conjunction with internal and ... a cross-functional team.-Ensures project results meet requirements regarding technical quality , reliability, schedule, and cost.Monitors performance and recommends schedule… more
- Citigroup (New York, NY)
- … data operating model + Provisioning best-practice tools and capabilities + Implementing data controls, including data quality measurement and reporting + ... Monitor compliance with data governance standards and ensure data quality and integrity across domains + Drive Domain Operationalization and implementation… more
