- Merck & Co. (Rahway, NJ)
- …teams and the operational/executional arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary ... - Project Management Skills: strong knowledge of the principles of project management and clinical customer relationship management. - Technical Proficiency:… more
- Merck & Co. (San Francisco, CA)
- …Description Position Description: Associate Director, DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS) ... Under the broad guidance of the DSCS Digital Program Mgmt Lead, the Associate Director, DSCS Digital Project Manager, will be responsible for implementing… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Pediatrics will focus on driving strategy, development, and ... stages of development therefore requiring someone who has late vaccine clinical development and lifecycle management experience.The AVP will also be responsible… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Associate Director, Clinical Programming must have expertise in addressing technical challenges ... will be responsible for implementing new technological solutions for end users.The Associate Director, Clinical Programming manages and oversees JReview and SAS… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams.Responsibilities: Study Strategy: Provides the ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...and oversee completion of clinical trial protocols. Provides… more
- Merck & Co. (North Wales, PA)
- …programming activities for multiple and/or late stage drug/vaccine clinical development projects. -Accountability predominantly includes the development and ... tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The… more
- Merck & Co. (North Wales, PA)
- …PowerPoint, Word, Outlook, etc.)Education/ExperienceBachelor's Degree +9 years of pharmaceutical, clinical drug development, project management, and/or medical ... field experienceOR Master's Degree +6 year of pharmaceutical, clinical drug development, project management, and/or medical field experienceOR PhD/PharmD Degree… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDevice Development Associate Principal Scientist - Development Strategy, Design Controls( Associate Director Equivalent) Our company's Device ... development and design control principles to positively support and influence clinical and commercial combination product development and launches to ensure they… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …signal detection and characterization for ongoing studies and compound level pooled clinical trial data of project (s). Act as statistical expert consultant ... minimal direction from group head and provide statistical scientific leadership for clinical trial safety data. Lead the statistical support for safety signal… more
- Merck & Co. (Durham, NC)
- …safety, quality and process enhancements throughout the supply chain - Project Management Lead and sponsor all Supply Chain Logistics initiatives surrounding ... (SOP) to align to SAP and business processes related to any new project implementations.Site supply chain lead and coordinator for the successful implementation of… more
- Merck & Co. (Rahway, NJ)
- …Material(s):n/aRequired Skills:Adaptability, Adaptability, Agile Methodology, Agile Project Management, Biopharmaceuticals, Biotechnology, Business, Clinical ... who are passionate about driving impactful changes. Position Overview: As the Associate Director of Launch Strategy and Operations, you will lead the enterprise… 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
- Eisai, Inc (Exton, PA)
- …well as supporting technology transfer to external partners (as required). The Associate Director sets strategic directions and project priorities, providing ... your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is...Operations groups to support the supply of DS/ADI for pre- clinical and phase I to phase III clinical… more
- Merck & Co. (Rahway, NJ)
- …and geographies.Demonstrated capacity to solve complex technical challenges, lead project teams, and influence stakeholders effectively.A solid understanding of ... Driving License:NoHazardous Material(s):n/aRequired Skills:Active Pharmaceutical Ingredients (API), Chemical Manufacturing, Clinical Manufacturing, Compliance Reviews, Data Analysis, Environment Health and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …level handles escalated global CSPV case processing issue and handles project . This position prepares trainings, supports CAPA investigations, case review, ... case processing and related CRO/vendor training needs and reviews case processing project specific training materials. Manages and coaches the PV Vendor Training… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of a CDx study/IVDR performance evaluation study integration of an assay into clinical testing (before testing) and once data is ready for CDx submission (after ... to external diagnostic business partners specifically:Use of CTA/CDx within clinical trialsDevice protocols and SAPsDevice non-significant/significant risk determinations (both… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team and serves ... as ad hoc member to the Global Project Team for late stage projects. This position manages...technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing… more
- Merck & Co. (Rahway, NJ)
- …opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of robust compositions, ... will preferably have experience with high concentration biologics to support clinical and commercial development. Maintaining a strong network internally and across… more
- Merck & Co. (Rahway, NJ)
- …build and lead a team of TA dedicated global and regional directors and associate directors. The EDMA engages with global scientific leaders and key decision makers. ... Development Team, Global Brand and V&I Outcomes Research leads to define clinical development plans and brand strategies for assigned TAsProvides a solid… more
- Merck & Co. (North Wales, PA)
- …and vaccines for the benefit of patients and global human health.The Associate Vice President (AVP), Late Development Statistics, BARDS, is responsible and ... President in BARDS and will work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs.--The AVP provides leadership and direction… more
