- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study teamsDevelop best practices and lessons learned mechanisms within Clinical OperationsDevelop risk assessment & risk management and clinical ... on behalf of the Study Management Group Heads and/or Vice President, Clinical Development Operations.Contribute to and/or lead in the development and growth… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …MD, will lead the development and implementation of integrated project/product risk management strategies aimed at achieving the optimum benefit- risk ... a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management , Biostatistics, Pharmacology, and other… more
- Merck & Co. (Rahway, NJ)
- …design, global filing and launch strategy, long-range demand vs capacity planning, integrated risk management , cost of goods projections, post approval change ... process and method technical changes, robustness/quality/ productivity projects. Manage product supply risk through Integrated Risk Management (IRM) and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role ... OverviewThe QA Investigation Lead is an exempt level position reporting to the...Actions (CAPA's) are developed and implemented.Escalation of events to management that potentially represent significant quality issues or issues… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …signal, epidemiological data, and regulatory requirement synthesize into a coherent risk management strategy.Represents the CSPV department as subject matter ... cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily strategic initiatives… more
- Merck & Co. (Durham, NC)
- …transition plans to the new source of supply or for post-change supply) Risk Management Proactively identifying and mitigating risks and participating in ... project objectives and defined business requirements through exceptional project management . The incumbent will lead cross-functional teams...Integrated Risk Management (IRM) Identifying and raising issues… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …access programs.Partner with Medical Affairs to facilitate the implementation of a risk -based quality management process fully embedded through trial design, ... Process for the respective business areas.Responsibilities:Leadership and Project Management : Lead the end-to-end quality execution across Medical Affairs… more
- Merck & Co. (Rahway, NJ)
- …approaches, and strong industry and FDA connections to our company. They will lead a team of CMC professionals, ensuring rigorous CMC regulatory strategy and ... approaches with FDA and other regulatory authorities. This role will also be a lead and advocate for digital innovation and leveraging it for how we operationalize… more
- Insmed Incorporated (San Diego, CA)
- …teams and senior leadership, as neededCollaborate with Clinical Development, Clinical Operations, CMC, QA/QC, Nonclinical, Program Management , and external ... within gene therapy or orphan (rare) diseasesPrior experience serving as the regulatory lead on cross functional teams (CMC, clinical and project teams)Ability… more
- Merck & Co. (Rahway, NJ)
- …investigations, corrective action/preventive action, procedural controls, auditing and Quality Risk Management .Deliver stewardship for our Company corporate ... Risk Assessments, Quality Assurance (QA), Quality Assurance Systems, Quality Management , Quality Oversight, Quality Risk Management , Quality Systems… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to drug product manufacturing required to deliver time, cost, quality, and risk management to teams.Experience with Healthy Authority requirements and regulatory ... a manufacturing readiness strategy to deliver capacity ramp up to meet clinical and commercial demand.Drive capacity evaluations and lead action implementation… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …its application to drug development required to deliver time, cost, quality, and risk management to teams.Demonstrated results in creating and managing complex ... Role OverviewThis position will be responsible for providing operational excellence project management support to the cGMP Clinical and Commercial Cell Therapy… more
- Merck & Co. (Rahway, NJ)
- …and category strategy alignment, sourcing and contracting execution, contract and claims management , project and risk management practices, and supplier ... all capital projects. Contribute to unified category strategies and ensure supplier risk management aligns with market conditions and business objectives.… more
- Merck & Co. (Rahway, NJ)
- …(small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant under construction in Rahway, New Jersey. The y ... members to ensure the quality and safe delivery of clinical supplies . Once the MACS Center is operational...multi-task. - Desire and willingness to learn, contribute and lead . - Track-record of independent problem-solving. - Strong communication… more
- Formation Bio (New York, NY)
- …CMOs, software vendors, and other biotech service providers. Knowledge of contract law, risk management , and compliance in vendor agreements. Ability to work ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …performance metrics to ensure departmental KPIs and regulatory compliance are met Lead deviation management activities, including root cause analysis and ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...process improvements related to patient safety. Also support case management activities within US Patient Safety Team. Relationship Reports… more
- CHRISTUS Health (Arp, TX)
- …be provided by monitoring cases and claims, analyzing biometric and health risk assessment data, organizing disease management programs and proactively ... DescriptionSummary: The Registered Nurse Patient Navigator Lead is a Registered Nurse or licensed Nurse...of case management on the patient population.Create outcomes- management focus by interdisciplinary analysis of specific clinical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Strong financial acumen with experience managing budgets, forecasts, and headcount planning. Risk Management : Ability to identify, assess, and mitigate ... to issues, and demonstrated passion for creating new medicines.Leadership & People Management : Proven ability to lead cross-functional teams, manage performance,… more
- Merck & Co. (Rahway, NJ)
- …aseptic qualification and performing environmental monitoring.Ability to develop and lead others.Ability to be flexible and understand risk .Collaboration: ... biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical manufacturing plant in Rahway, New Jersey. The Sterile Production… more
- Merck & Co. (North Wales, PA)
- …acquisition of EyeBio. One of our key products is currently in Phase 2b/3 clinical trials for the treatment of diabetic macular edema. The product aims to provide ... age-related macular degeneration, or wet-AMD. Additional pipeline candidates include clinical and preclinical assets being developed for the prevention and… more
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