- 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
- CHRISTUS Health (Tyler, 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)
- …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. (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
- 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
- Ochsner Health (Lafayette, LA)
- …in 1942, but one thing has never changed - our commitment to serve, heal, lead , educate, and innovate. We believe that every award earned, every record broken and ... Acute care hospital experience and specific experience in the clinical services CertificationsRequired - Current Louisiana Certification as a Nurses'… 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. (North Wales, PA)
- …to support the EDSA review process. Manages programs (patient support, educational or risk management ) to support appropriate and safe utilization of Our Company ... assigned therapeutic area#eligibleforERPRequired Skills: Budget Management , Budget Management , Business Acumen, Business Administration, Clinical Development,… 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
- 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
- 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
- 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
- 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. (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
- 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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …art presentation skills, power point, Visio, budget, resources, algorithms, projections, risk management and mitigation. Operational Oversight and Reporting: ... promotion of the 6th Mid-Term Strategy for Global QA, lead the execution of the business plan, and manage...talent through mentoring and high expectations. Develop, Execution and Management of Global R＆D PV QA Mid-Term Strategy and… more
- Lundbeck (North Hyde, SD)
- …audits and represent the affiliate in global QA forums. Maintain SOPs, Crisis Management documentation, and Risk Management Plans. Provide training to ... currently seeking a highly motivated and experienced Regulatory Affairs Manager to lead and manage regulatory activities across our product portfolio. This role is… more
