- Merck & Co. (Durham, NC)
- … safety , and sustainability (EHS&S) opportunities.- Ensure comprehensive change management of all EHS and Site initiatives to ensure ongoing complianceDrive ... Corporate Management , Cross-Cultural Awareness, Detail-Oriented, EHS Program Management , Emergency Response, Environmental Health and Safety (EHS)… more
- Merck & Co. (Rahway, NJ)
- …Senior LeadersAPI Small Molecule Manufacturing and Potent Compound Handling ExperienceProcess Safety Management , Emergency Management , And Incident ... support business objectives, with focus on Process Design and Process Safety for Small Molecule High Potency/Containment Projects. Develop project scope, front-end… more
- Merck & Co. (Rahway, NJ)
- …Power Engineering, Engineering Design, Engineering Standards, Environmental Health and Safety (EHS) Management , HVAC Systems, Identifying Risks, Maintenance ... Processes, Management Process, Programmable Logic Controller (PLC), Safety Leadership, Smart Devices, Social Collaboration, Strategic Thinking {+ 4… more
- Merck & Co. (Durham, NC)
- …cGMP Compliance, Communication, Computer Literacy, Data Analysis, Environmental Health and Safety (EHS) Management , Lean Manufacturing Tools, Management ... develop remediation plans when applicableCollaborating across diverse teamsCreating strong safety cultureContributing to the manufacturing team and support for the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …risk factors with and for other technical departments (eg, Clinical, Medical, Safety , Data Management , Statistics). This position requires skills in working ... trial monitoring and execution through RBQM activities. Accountable for the management , performance, and development, both technical and career, of direct reports,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(PV) oversight. This role fulfills the PV Oversight for NNI Patient Safety processes and as providing SME-level input from the affiliate perspective when ... relationship to business improvement projects. Interact closely with NNI Patient Safety and NAO Quality Audits & Inspections. External relationships include… more
- BioAgilytix (Durham, NC)
- …patients who need them.In this full-time role, you are responsible for GxP-compliant management of incoming and outgoing biological samples. Our clients trust us to ... and you will ensure the samples are checked into our Laboratory Information Management System (LIMS), managed according to our procedures, and available to our… more
- Eisai, Inc (Nutley, NJ)
- …related technical and end user support to other areas of Data Operations, Data Management , Clinical Safety Data Review and Clinical team. The Assoc. Director of ... validation, technical documentationManage J-Review set up, J-Review user access management , training, programming support & upgrades Manage automated process for… more
- Twist BioScience (South San Francisco, CA)
- …activities and initiatives under the guidance of senior staff.Monitoring waste management services provided by external vendors to ensure compliance and ... adapt to evolving EH&S requirements.B.S. degree in Occupational Health and Safety , Environmental Science, Environmental Engineering, or an equivalent field; or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …HCP letters and key medical education initiatives.Develops prospective contingency plans for management of assigned safety risks across projects; Clearly defines ... improvement of Clinical Development processes. Job Description:Execute an overarching safety program tailored for AEs from end-to-end: understanding predisposing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Local/Global Pharmacovigilance (PV) service providers responsible for Call Center, individual safety case processing, and aggregate reporting for DSI products, both ... and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic reporting. Contribute as a key DSI contact for PV… more
- Merck & Co. (Durham, NC)
- …(with External Partner).-- Compliance:-Achieve compliance goals through a risk-based approach ( Safety Regulations, Quality Assurance, Risk Management , Deviation ... to deliver Pharmaceutical, Biologic, and Vaccine Products. Our team works with a " Safety First, Quality Always" mindset.-As the primary point of contact for all… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …investigations, case review, documentation reviews in collaboration with the ICSR management and CRO/Vendor oversight groups for case processing activities and ... reports to the Director of PV Case Management .Responsibilities:ICSR Processing: Oversees QC activities, supports projects and interacts with the DSI Case … more
- Genmab (NJ)
- …one study are in scope.The Programming Manager will support the Data Management , Statistics, Drug Safety , Medical, Clinical Pharmacology and Biomarker functions ... committees, answers to in-house questions related to data quality, safety monitoring, medical questions etc.Performs sponsor oversight of programming activities… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …focus, for supporting and upholding processes anchored in the NN Quality Management System (QMS) across NAO thereby ensuring highest quality to patients. This ... Interacts closely with Marketing & Patient Support Solutions and NNI Patient Safety . External relationships include interactions with NNI vendors involved in the NNI… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Novo Nordisk requirements in relation to Pharmacovigilance (PV) oversight and deviations management . This role fulfills the PV Oversight function in PV deviation ... management processes, as well as providing SME-level input from...closely with Marketing & Patient Solutions and NNI Patient Safety . External relationships include interactions with NNI vendors involved… more
- Merck & Co. (Durham, NC)
- …people that make our products. We work in the manufacturing plants with a " Safety First, Quality Always" mindset striving for continuous improvement. We work in the ... of new systems which enhances the operation and/or engineering processes.Quality & Safety Compliance:The successful candidate should be able to examine an issue from… more
- Merck & Co. (Rahway, NJ)
- …solutions.Manage hourly unionized staff and administration of contracts.Promote and model safety leadership principles and advocate for safety programs.Stay ... operations in pharmaceutical environments.Prepare and present reports to senior management on HVAC system status, risks, and improvement initiatives.Responsibility… more
- Merck & Co. (Durham, NC)
- …work order proper handling.Train other mechanics on shift.Participate of Safety Walkthroughs and GEMBAs.Additional Responsibilities:Must be flexible to perform all ... PM's, installing new equipment, documenting work using a computerized maintenance management system (SAP) and other duties as requested by the Coach… more
- Merck & Co. (Rahway, NJ)
- …will be to maintain all equipment in accordance with GMP and Safety requirements, as well as exercising Reliability Maintenance best practices to ensure ... Partner Groups such as GES (Global Engineering Services), Facilities Management (FM/GWES) and Original Equipment Manufacturers (OEM) and vendors.Provide engineering… more
