- Merck & Co. (Durham, NC)
- Job DescriptionLead Technician, Calibration and Maintenance (O4) Lead Maintenance Technician will be a leader with strong interpersonal, communication, and ... in supporting the manufacturing process. Individual will possess the ability to lead a team, train others and contribute to and implement process improvements.The… more
- Merck & Co. (Rahway, NJ)
- …for an engaged and energetic, people-oriented leader with advanced technical skills to lead , develop, and mentor an international team of skilled engineers. For our ... organization, we are currently recruiting a Global Engineering Solutions Technology Center Lead (Animal Health)Welcome to our teamWith more than 300 employees, our… more
- Aequor (Devers, TX)
- Environmental, Health, and Safety Senior Specialist (EHS Senior Specialist)Devens, MA 100% Onsite role This position will support the First Shift/12 hours. Top ... Must-Haves: Detailed experience with Contractor Safety , Safe Work Permit Program SupportEHS training and Risk/Hazard AssessmentInitiative/autonomyEHS audits/Field… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Aseptic Manufacturing LeadPosition Summary:The Aseptic Manufacturing Lead plays a critical role in overseeing aseptic manufacturing activities. A strong background ... microbiology and experience in aseptic manufacturing are required. The Aseptic Manufacturing Lead will actively participate on the production floor by leading a team… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …colleagues/direct reports in audit/inspection preparedness and participation Serves as NAO's Lead regarding FDA and Health Canada safety reporting ... As North America responsible person, the head of Patient Safety will act as the safety expert...for regulatory authority inspection and internal audits for PV operational activities for NAO; participate in audits/inspections as Subject… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Maintains oversight of DSI contracts that ... Local/Global Pharmacovigilance (PV) service providers responsible for Call Center, individual safety case processing, and aggregate reporting for DSI products, both… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Team (GPT) as an ad hoc member and independently provides strategic and operational leadership on new product labeling in collaboration with the Global Regulatory ... Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position...Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …choices, drive core operations and develop insights to drive growth and operational excellence across the value chain while innovating for future capabilities. Our ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …study protocol, and identifying areas of concern and escalating to Clinical Program Lead when appropriate Collaborate with the Clinical Program Lead and study ... team to develop patient recruitment strategies, operational feasibility and implementation of study objectives Develop study plan(s) including key milestones and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …choices, drive core operations and develop insights to drive growth and operational excellence across the value chain while innovating for future capabilities. Our ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Merck & Co. (Durham, NC)
- …therapies for our patients. We work in the manufacturing plants with a " Safety First, Quality Always" mindset, striving for continuous improvement, and earn our ... and warehouse.-As the team finishes design and construction of the facility, the Lead Technician will play a critical role in supporting the Global Engineering… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new ... promotion recommendations.-Possesses innovative mindset focused on continuous improvement and operational efficiency within team in addition to cross-functionally.-Displays collaborative… more
- Insmed Incorporated (San Diego, CA)
- …Medical Director of Ophthalmology, Clinical Development holds the responsibility to lead clinical programs across different diseases and supervise the clinical ... first-in-human trials, through to full development.Serve as the therapeutic area lead of the ophthalmology clinical development team, partnering closely with heads… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …choices, drive core operations and develop insights to drive growth and operational excellence across the value chain while innovating for future capabilities. Our ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical Biomarkers, etc.) Clinical Safety , CROs and External Vendors for the data services they provide ... Monitor vendor metrics and provide feedback on performance to Joint Operational Committees (JOCs). Develop Key Performance Indicators and ensure sufficient… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …principles, processes, technologies, and talent management.Key Responsibilities Develop and lead an effective manufacturing and supply organization, supporting teams ... market.Provide both technical and managerial leadership across all cGMP-related responsibilities. Lead and ensure strong delivery in areas such as Procurement,… more
- Merck & Co. (Rahway, NJ)
- …strategies for investigational drugs and planning clinical trials (design, operational plans, settings) based on these clinical development strategiesMonitoring and ... and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads ... involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …choices, drive core operations and develop insights to drive growth and operational excellence across the value chain while innovating for future capabilities. Our ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …members, and peers.Harmonize with Environmental, Health, and Safety personnel, Product Development, andQuality/Manufacturing personnel.Independently makes ... management.Generates shift schedules, to ensure efficient coverage for all operational needs.Maintain individual training completion in a compliant state.Supports… more
