- Merck & Co. (Durham, NC)
- … Quality Systems: Deviation Management , Complaints, Corrective Action/Preventive Action Management , Annual Product Review Authoring, Quality Risk ... Systems (Deviation Management , Complaints, Corrective Action/Preventive Action Management , Annual Product Review Authoring, Quality...Authoring, Quality Risk Management , and Quality Council), the Associate Director will be… more
- Merck & Co. (North Wales, PA)
- …b) Data Mastering, Data Governance including but not limited to Data Marketplace, Data Quality , Data Risk Management c) Value Realization with use of these Data ... execution for successful delivery across various teams and vendor partners to meet product line objectives with high quality , timeliness, and within budget /… more
- Merck & Co. (Rahway, NJ)
- …License:Hazardous Material(s):Required Skills:Asset Management , Benefits Management , Management System Development, Product Management , Requirements ... animal species. About the Position The Animal Health IT Customer Master Data Management (MDM) Product Owner collaborates with stakeholders across all levels of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as achieving overall project level quality metrics. An ideal Associate Director , Program Management must have the expertise and leadership to manage ... areas centered around rare diseases and immune disorders. Summary The Associate Director , Program Management is a senior position responsible for effectively… more
- Insmed Incorporated (San Diego, CA)
- …Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Associate Director , Quality Assurance - Analytical,GMP has responsibility for the ... Provide expert QA review, collaboration, and direction for laboratory investigations.Apply Quality Risk Management for key processes and systems. Identify… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, ... and inclusive work environment.Essential Knowledge, Duties & Responsibilities for the Director Include:Sterile drug product development concepts, tools, 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)
- …ability to collaborate well with people from many different disciplines.Project management experience specifically related to product source management ... Job DescriptionThe Director of Business Systems and Process Improvement leads...and continuous improvement initiatives within Animal Health Global Supplier Management (AH-GSM). This role also manages global procurement systems… more
- Merck & Co. (Rahway, NJ)
- …process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for proactive ... talent.Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related to product release and safety.NOTICE FOR INTERNAL… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to… more
- Merck & Co. (Rahway, NJ)
- …development and GMP clinical supply manufacture of our Company's drug product pipeline.- The FLEx Process Engineering Lead drives process development expertise, ... formulators and device engineers to develop robust and innovative drug product manufacturing processes.- Close partnership with colleagues from Formulation Sciences,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management , Biostatistics, Non-clinical, Medical Affairs, Marketing, Legal, Quality , ... us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop new… more
- Eisai, Inc (Nutley, NJ)
- …Summary The Director is responsible for developing strategies for assigned product (s) and execution of HEOR and RWE research for the development and ... communication of product value data to support Eisai business. This role...research activities and development of external communication materials. The Director facilitates coverage, reimbursement and appropriate utilization based on… 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, ... drug products consistent with the company goals; specifically, for the life-cycle management of NDAs/BLAs. This individual will be responsible for working on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Job Summary: The Director , Diagnostic Sciences will be responsible for end-to-end process for CDx ... Diagnostics, Translational Sciences, Global Clinical Operations, Biostats and Data Management and Clinical Development.Responsibilities:Designs and leads clinical trial sample… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …process is maintained in a validated and controlled state and consistently delivers quality product meeting or exceeding the standard of various health ... in the treatment of multiple myeloma.Legend Biotech is seeking Director , Global Process Validation as part of the Technical...participation in a variety of cross functional CMC and quality forum under the Joint Manufacturing Committee in the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes Process Best Practices: ... serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member and independently provides strategic and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research relevant duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately. Ability to exercise ... plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents supporting GLP/non-GLP/ Research submissions… more
- Eisai, Inc (Nutley, NJ)
- …insights and predictive capability from statistical models.Clinical development and product life-cycle management .Vendor management .Economic modeling and ... this is your profile, we want to hear from you. Director , Global RWE & Data Science sought by a...that address issues such as payer challenges, impairments in quality of life and patient well-being, and gaps in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management , Quality Assurance, Medical Affairs, Translational ... management relationship and governance. Responsible for Strategic Application product roadmaps to meet business objectives.Work with User Support Leads and… more
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