- Merck & Co. (Rahway, NJ)
- …biologics process development.Experience in supporting compliance investigations and change management .Familiarity with US and EU GMP and Safety compliance ... that provides a high degree of technical and project management responsibility. The Specialist - Process /Facility Engineering...role at the Specialist level will serve as a process team member supporting the Modality Agnostic… more
- Merck & Co. (Rahway, NJ)
- …in Clinical Quality Management including Quality Control Activities, Process Management & Improvement. -Demonstrated, stakeholder management ... & Development (L&D), if applicable -In close cooperation with local country operations management and local CQM team , identifies / coordinates local training… more
- Eisai, Inc (Nutley, NJ)
- …understanding of their assigned IDNsAccount / market dynamics, stakeholder mapping / management , the HCP referral process , access, account department drivers, ... or mild AD. TheNeurology Account Specialist (NAS) will be part of a diverse team of sales professionals who support this important launch and will be responsible for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with action item published timely and plan agendas weeks ahead of schedule.- PM/OE Team Management and Development, Vendor Oversight:- Lead and manage a team ... processes, resource allocation, and risk management strategies leveraging project management tool functionality.- Oversee and manage global team events… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …is responsible for working with the business lead to ensure effective team operations through meeting management , development plan/timeline management , ... of professional pharmaceutical industry experience required- Proven expertise in project management required- Strong knowledge of patient safety and… more
- FlexStaff (New York, NY)
- …of care for a designated group of patients using the nursing process of assessment, diagnosis, outcome identification, planning, implementation and evaluation of ... patient care. Collaborates with physicians and other health team members in coordinating and implementing procedures and treatments. Uses leadership skills/clinical… more
- Merck & Co. (Rahway, NJ)
- …role at the Associate Director level will serve as a technical mentor and process team member supporting the Modality Agnostic Chemistry Scaleup (MACS) Center. ... technical mentorship.Experience in leading and supporting compliance investigations and change management .Familiarity with US and EU GMP and Safety compliance… more
- Merck & Co. (Rahway, NJ)
- …with capital projects that followed a stage gate capital management process Excellent collaboration and engagement as a team player with dependable ... experience with engineering design, equipment operation, vendor interface, risk assessment, process safety and industry guidance are essential for delivery… more
- Merck & Co. (Rahway, NJ)
- …with other Integrated Project Team (IPT) members (eg, Project Management , Technology, Maintenance, Automation, Plant Operations and Safety ), Engineering ... of experience with engineering design, equipment operation, vendor interface, risk assessment, process safety and industry guidance.- Project Size is anticipated… more
- Merck & Co. (Rahway, NJ)
- …and operational experience to lead and support facility operations, process development activities, compliance investigations/change management , authoring of ... provides a high degree of technical, project, and people management responsibility. - This SSO Facility Lead role within...candidate will be an integral member of the SSO process and production team at the Rahway… more
- Merck & Co. (Rahway, NJ)
- … selection through deep fundamental understanding and characterization such that the process is scalable without compromising stability, safety , efficacy, and ... cutting edge analytical tools, and predictive approaches to inform molecule, formulation and process selection. In summary, our team enables the translation of… more
- Merck & Co. (Rahway, NJ)
- …analysis of GHG data in close collaboration with our Environment, Health & Safety (EHS) team .Develop minimum supplier GHG emissions data requirements that enable ... Environmental Sustainability Scope 3 Council sits within our Global Supplier Management Group (GSMG). We inspire, educate, and empower people to make… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …activities for internal QA team (global/ local), and not limited to: Global Project Team , Safety Management Team , Clinical Safety and ... Medical Affairs, Companion Diagnostics/ Device Laboratories Vendors/ CROs Leadership/ Team Management Create a high performing ...GvP modules in support of a proactive quality risk management process .Interact with the audit and compliance… more
- Merck & Co. (Rahway, NJ)
- …and accelerate process and product development and manufacturing and ensure safety and quality of our products. -The successful candidate will be accountable for ... Job DescriptionOur team in Rahway, New Jersey, is seeking an...laboratories, complementary areas of Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects… more
- Merck & Co. (Rahway, NJ)
- …for the team , and implement and manage change to enable process improvement and optimal workflows.Responsibilities include, but are not limited to, the ... Enabling Capabilities and will be directly responsible for a multidisciplinary team of people managers and scientists, approximately 50-60 people across our… more
- Merck & Co. (Rahway, NJ)
- …to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of our company's Research & Development Division by:Developing an ... activities of the General Medicine global regulatory therapeutic area and team leading to global innovative and accelerated regulatory strategy and marketing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …on process implementations and metrics. - Cross-functional and Global Team Participation :Proactively collaborate with other GxP quality representatives and act ... process support; ensure timely and effective preparation and management of HA inspections, including facilitation of respective regulatory inspection preparation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strategy; Accountable for performance of CROs; Routine interactions with senior management of CRO, as needed; Accountable for clinical development plans, protocol ... profiles and sections of key submission documents; Represents Clinical Development as team leader or as supervisor of team leaders; Accountable for Clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …best practices. Assist or lead the development of Standard Operating Procedures (SOPs) and process improvements. Conduct team meetings with direct reports or a ... 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. (Basking Ridge, NJ)
- …as well as management of adverse events based upon approved Safety Management Team (SMT) materials- Supports overall program ... assessment of protocol deviations- Discusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of… more
