- Catalent (New York, NY)
- …patients. Milestone management and right first time for themselves and their team with patient safety in mind, executing with efficiency always. Quality, ... strategic account plan(s), if applicable.Provide business and overall relationship management support to existing development programs. Responsibilities may include… 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)
- …Scientist reports to the Senior Director Chemical Biotechnologies of Process Research & Development Enabling Technologies, our Company's Research Laboratories. ... pipeline of the future. This includes technical oversight of laboratory-based process development and characterization, scale-up and activities to support technology… more
- Merck & Co. (Rahway, NJ)
- …daily and longer term)Lead daily toolbox talks in support of target Zero Safety cultureEnsure assigned team 's compliance --with company assigned or mandated ... Assistant Operations Supervisor The Assistant Operations Supervisor will work in a team environment to understand, anticipate, and manage operational challenges in a… 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)
- …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)
- …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
- Merck & Co. (Rahway, NJ)
- …include but are not limited to: 24-hour monitoring building management system Installing, maintaining, and repairing ventilation and air-conditioning systems ... requirements Assisting with customer inquiries Supports a Target Zero Safety culture Utilizes electronic technologies; electronic work order systems,...and the ability to work as part of a team is a must.Applicants must be familiar with all… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of Development Safety Update Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) according to ... make a difference?The Position This leadership role is accountable for developing the safety strategy, major safety deliverables for assigned programs within the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …insights to the lines of business Develops supplier selection criteria and facilitate team members through a disciplined strategic sourcing process focused on ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… 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
- 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
- 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)
- …from end to end in collaboration with Physician Scientists and the study team (data management , clinical operation and other functions) to implement clinical ... clinical data review excellence with a focus on patient safety and data integrity, site scientific engagement, and HA...as well as external investigators is expected. Depending upon team composition and scope of program, the CS lead… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the CRO and vendor selection process in collaboration with the study team and outsourcing procurement management .Lead the creation of the CRO scope of ... site identification activities in collaboration with the CRO and the study team . Oversee the site qualification process .Monitor clinical trial performance and… more
