- 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
- 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
- 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)
- …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
- 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
- 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
- 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
- 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.Lead the definition of solutions based… 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 ... harmonization of programming processes supporting global submission.Responsibilities- Statistical Programming Management : Coordinates outsourced statistical programming of analysis data sets… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to meet smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate ... simultaneously. preferred- 4 or More Years Extensive experience in project management , process, product , and/or analytical development activities and… 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
- 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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position ... functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategizes and plans for FDA meetings as needed. Acts as… 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
- 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)
- …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
