- Insmed Incorporated (San Diego, CA)
- …Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director ... Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs,...regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical … more
- Merck & Co. (Rahway, NJ)
- …organizations ( as a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing.... - Familiarity with Good Manufacturing Practices (GMP) requirements, quality procedures, and Standard Operating Procedure (SOP) execution. -… more
- Eisai, Inc (Nutley, NJ)
- …environment and make a difference. If this is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director , Clinical ... Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard...Eisai Salary Transparency Language:The base salary range for the Director , Clinical Quality Assurance is… more
- Merck & Co. (Rahway, NJ)
- …solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory, Operations, Non- clinical , Clinical , and other ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan, ... NJ. Role OverviewThe Director of Operations is an exempt level position working...production of a personalized cell therapy to support both clinical and commercial requirements in either a Grade C… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Merck & Co. (Durham, NC)
- …routine internal and external GMP and Financial audits, QSAT actions, to ensure compliance .- This is a fast-paced and multi-faceted role that provides leadership and ... a wide range of business activities.- Reporting directly to the Director , Supply Chain Management, the successful candidate's primary responsibilities will include… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategies and tactics that will Improve strategic planning Expand and improve the quality of clinical research Increase accuracy of medical and marketing ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Merck & Co. (San Francisco, CA)
- …Skills:Budget Development, Business, Clinical Supply Chain Management, Clinical Trial Management, Compliance Frameworks, Cross-Cultural Awareness, Decision ... Job Description Position Description: Associate Director , DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS)… more
- Merck & Co. (Rahway, NJ)
- …operations staff, quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ... Data-Driven Decision Making, Drug Product Development, Estimation and Planning, GMP Compliance , Management Process, Manufacturing Quality Control, Medical Supply… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole Summary:The Executive Director , Value & Implementation (V&I) Outcomes Research position resides in the V&I organization, which includes Global ... cross-functional teams is a critical part of this role. The Executive Director has scientific and budgetary oversight for all outcomes research activities conducted… more
- Eisai, Inc (Exton, PA)
- …close-out of documentation, manufacture of DS/ADI materials, and suite change-over ensuring compliance to relevant regulations. The Associate Director is also ... If this is your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading and building a… more
- Merck & Co. (Rahway, NJ)
- …upstream and downstream processes that produce high yields along with superior product quality and allow speedy progression for clinical studies and commercial ... pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research… more
- Merck & Co. (North Wales, PA)
- …clinical data/medical protocol deviations in collaborations with the Clinical Director .Other responsibilities include:Collaborating cross-functionally in the ... protocol in collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. Associate Director , Medical Education - Oncology, is responsible for the strategic planning and execution ... Affairs functions and regions, in addition to Publications and Scientific Communications, Clinical Development, Field HEOR, and others to execute on deliverables as… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pull you in? Are you ready to experiment with us? The Position The Associate Director of Nephrology Key Opinion Leader Marketing will be a pivotal driver in shaping ... with brand/therapy area vision and message. Relationships Reports to Senior Director of Cardio Renal Marketing Responsible for providing interface with key… more
- Merck & Co. (Rahway, NJ)
- … clinical data/medical protocol deviations in collaborations with the Clinical Director . Other responsibilities include: Collaborating cross-functionally in ... protocol in collaboration with Data Management/Programming. Collaborating cross-functionally to monitor clinical data -to ensure quality , completeness , and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …forecasting to identify market trends, leading a high-performing team while ensuring compliance with legal standards. The Director will drive informed ... in? Are you ready to experiment with us? The Position The Director , Market Intelligence and Portfolio Insights will leverage Competitive Intelligence methodologies… more
