- Merck & Co. (Rahway, NJ)
- …and Development Sciences (RaDS) value team in Our Company's R&D IT brings together product management , engineering, and data science expertise to enable ... data standards, taxonomies, and ontologies to ensure consistent and accurate data representation. Data Management and Integration:Oversee the management… more
- Merck & Co. (Rahway, NJ)
- …close partnership with After Sales teamsFoster strong and effective partnerships towards product creation with important internal (Tech Labs, Data Labs, ... The chosen candidate will be responsible for creating and executing the product strategy, adoption, deployment, marketing, and commercial activation for the new… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … stewardship and governance processes, data cataloging data standards, data quality, and data management .- Develop and implement strategies for ... cleansing and standardizing data , with a focus on eg, clinical, product...program, data stewardship program or similar intent data management program focused on setting standards,… more
- Merck & Co. (Austin, TX)
- …SLP , S upplier analytics and risk management applications. - Exposure to SAP Master Data Management and Cross functional integration with ERP and 3 rd ... Proficient level of experience and knowledge of SAP Vendor Master Data , Ariba Supplier Lifecycle and Performance,...Project Lifecycle, IT Service Delivery, IT Systems Development, Meeting Management , Product Management , Product… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Technology Management (mAb, Drug Substance, Drug Product , or New Modality) Lead ... is responsible for the management of technology transfer of the manufacturing processes of...of the manufacturing processes of (mAb, Drug Substance, Drug Product , or New Modality) for investigational and commercial drugs… more
- Merck & Co. (Austin, TX)
- …- Proficient level of experience and knowledge of SAP Vendor Master Data , Ariba Supplier Lifecycle and Performance Management , SAP Ariba procurement. - ... Implementation, IT Project Lifecycle, IT Service Delivery, IT Systems Development, Meeting Management , Product Management , Product Roadmapping, Project… more
- Merck & Co. (North Wales, PA)
- …engagement perspective as well as deep technical understanding of Life Sciences data sets (eg, claims, electronic health records) and advanced modeling approaches. ... roles translates brand specific customer journeys and engagement strategies into the data and algorithms required to determine the appropriate channels and timing… more
- Novo Nordisk Inc. (Boulder, CO)
- …usage Execute system transactions including purchase requisitions, purchase orders, goods receipts, master data creation etc and support team members with ... in a GxP environment to be responsible for end-to-end supply chain inventory management from raw materials through drug product performed internally or at… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is ... compliance, and patient safety related to managing assigned clinical trials, document management and management of clinical trial management systems… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is ... but not limited to, service agreements, research partnerships, sponsorships, memberships, data sharing, non-disclosure, and master service agreements across a… more
- Aequor (New Brunswick, NJ)
- …degree required Must Haves: 8&plus years of experience in Stability Program Management for small molecules (oral and sterile product ) Strong understanding ... stability ICH guidelines and cGMP regulation Very good experience on New Product Introduction Very good understanding on Regulatory CMC , US/EU/ROW submission… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …in support of commercialization. Serve as a technical resource to improve product quality, reliability, and process capability. Support manufacturing to satisfy the ... guidance for the validation program, Policies and SOPs and other master documentsSupport Engineering and Manufacturing in the development of critical process… more
- Aequor (Thousand Oaks, CA)
- …submission strategy Act as a functional area representative and lead on product teams Assist with the following activities: hiring, resourcing therapeutic areas and ... design and principles of good medical writing to the department and product teams Participate in departmental meetings, as well as departmental and… more
- Merck & Co. (North Wales, PA)
- …(CSS) group within BARDS supports proactive assessment, transparent communication, and effective management of product risk profiles across our Research and ... and data processing software eg SAS and/or R.-Good project management skills. --Good understanding of worldwide regulatory requirements and clinical trial… more
- Merck & Co. (Rahway, NJ)
- …business strategy enhancement. They oversee diverse initiatives, such as new product launches, innovative business models, biopharma and technology solutions, and ... not limited to:Drive launch excellence: Successfully deliver 5YP numbers for designated- product line, ensuring a seamless and effective product launch.Map TOP50… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ADaM data set specifications, reviewer's guides, etc.- Global Biostatistics Data Management (BDM) Strategy to Improve Drug Development: Leads implementation ... Collaboration: Provide leadership for strategic and process improvement initiatives within Biostatistics Data Management . Works with colleagues at DST and DSE to… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It's ... and lead day-to-day QC Microbiology activities for routine in-process and product testing ensuring compliance, accuracy and timeliness of testing processes in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position ... Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance… more
- Catalent (Harman, WV)
- Position Summary The Director, Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation ... management , CAPA tracking, change control, risk management ,...and the release of drug substance and/or final drug product to support Phase I/II clinical trialsWork with clients… more
- Merck & Co. (Rahway, NJ)
- …with application to drug substance and a broad array of drug product dosage forms, combination products and modalities through analytical characterization, imaging ... tools, and data analy sis. You would also contribute towards regulatory...of the-future.- Author investigational new drug (IND), investigational medicinal product dossier (IMPD), and new drug application (NDA)/ worldwide… more
