- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & ... for global processes across Global Regulatory Affairs and Clinical Safety . The Global Process Lead actively...and Clinical Safety . The Global Process Lead actively engages with leadership across the Global Regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and external stakeholders on important drug safety issues supporting Global Medical Safety Lead . Responsible for safety governance/oversight of Clinical ... diseases and immune disorders. Job SummaryThe position develops the global safety strategy, oversees risk management activities, and recruits and develops staffing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Study Report (CSR). May review tables, listings, and figures (TLF) and CSR safety narrativesMay lead the development and updates of the Investigator's Brochure ... assessment of protocol deviationsDiscusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse… more
- Aequor (South San Francisco, CA)
- …The group provides fit-for-purpose wet lab-based investigation to address target safety assessment, lead optimization and issue mitigation by employing ... collaborating with scientists across the organization to support the overall safety assessment for our Client therapeutics spanning drug discovery through clinical… more
- Merck & Co. (Durham, NC)
- Job DescriptionLead Technician, Maintenance (O4) Lead Maintenance Technician will be a leader with strong interpersonal, communication, and collaboration skills ... 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and ... of systems development for global informatics systems, ETL and integrations. The Tech Lead must develop and implement informatics systems and programs to support the… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …support of inspecting, packaging and/or labeling pharmaceutical products in compliance with all safety policies, cGMPs, and SOPs. The Group Lead , Finishing will ... Position Summary:A Group Lead , Finishing is responsible for coordinating daily finishing...work in compliance with applicable SOPs, cGMPs, regulatory requirements, safety , environmental and company policiesPerform other duties as assignedRequired… more
- Aequor (Devers, TX)
- …stakeholder groups.Roles & ResponsibilitiesProject Support:Work with the Lab Operations Lead to coordinate day-to-day activities of multiple projects.Prepare and ... (oral and written).Provide administrative support as needed.Project Management:Coordinate the safety and lab operations team to harmonize processes and procedures… more
- Merck & Co. (South San Francisco, CA)
- …experience in complex cellular model/assay development, mechanistic pharmacology, and lead discovery support to join our Quantitative Biosciences (Pharmacology) ... and assay protocols, and comply with all laboratory training and safety requirementsCollaborate with colleagues on multi-disciplinary project teams to provide… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... us? The Position The Associate Director will be the lead who is responsible for ensuring that all aspects...ensuring that all aspects of our patient quality and safety operations meets standards. This position requires a highly… more
- Aequor (Swiftwater, MN)
- …reports. Primarily bench-scale lab work with some administrative work. Follow company safety procedures and compliances. Lead investigations to resolve problems ... and to identify root causes. Will be required to work with glass and stainless steel reactors and be comfortable with manual labor. Familiarity with ascetic techniques is a must, familiarity with bioreactors is a plus. Meet project requirements and… more
- Merck & Co. (Durham, NC)
- …that training and certification are assigned and completed as expected - Quality & Safety Compliance: Foster strong safety culture on the team through actions, ... coaching, and prioritization Participate in safety /regulatory audits (ie tours, topic discussion) Coach individuals when...of mechanical, electrical and automated systems and equipment- Actively lead the daily Tier 1 Process and participate in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads the ... a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of responses to comments from… more
- Merck & Co. (Rahway, NJ)
- …is seeking a highly motivated and technically focused individual to lead the Crystallization Lab. Through direct, lab-based contributions and scientific supervision ... a team of crystallization subject matter experts, the Crystallization Lab Lead collaborates with cross-functional teams to ensure small molecule Active… 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
- Merck & Co. (Rahway, NJ)
- …Associate Director brings forward strong subject matter expertise to lead studies and evaluations, determine suitability, establish direction, conduct risk ... & Development Division Scientists, Maintenance, Automation, Plant Operations, and Safety ), Engineering Firms, and Vendors to progress deliverables.The Associate… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new ... Distinguished Scientist (Executive Director) and Product Development Team (PDT) Lead , Oncology Global Clinical Development, has primary responsibility for the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... such as Corporate Procurement, Global Legal Operations, NNI DD&IT, Legal, Privacy, Safety and line of business (LOB) leaders, and manage external relationships with… more
- Genmab (NJ)
- …Medical Director and other cross-functions to provide high-quality and timely deliverablesResponsibilities Lead or co- lead one or more complex clinical trial(s) ... and regulatory documents and registration dossiers (ie, protocol, ICF, IB, safety updates, study reports, regulatory submissions, etc.) to support registration and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads the ... Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of...Data Sheets, EU and US Documentation: As the project lead , Independently or through direction of a team of… more
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