- Insmed Incorporated (NJ)
- …You'll Do: Lead the DSPV Medical Safety Strategy and Benefit- Risk Management group providing strategic direction, oversight and leadership across ... expert safety review input into all critical documents for clinical development of products including protocols and amendments, ICFs,...materials. Lead the development and ongoing review of Risk Management Plans (RMPs), Risk -Evaluation… 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
- Revel IT (Tucson, AZ)
- …for quality implementation in complex projects in the following areas: project risk management , critical path analysis, scenario creation and analysis, budget ... (cQCR, SCR & fQCR), etc., as applicable, and may lead improvement initiatives. Implement best practices in project/product teams...well as the broader organization in holistic planning, project risk management , scenario creation as well as… more
- Insmed Incorporated (NJ)
- …Clinical Operations timelinesFoster and manage strategic supplier relationships, lead vendor selection, performance monitoring, business review governance, and ... the future of science, we're in. Are you?About the Role:The Director of Clinical Supply Chain Operations is responsible for leading global demand planning and… 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
- Merck & Co. (Rahway, NJ)
- …product development, such as manufacturing process development and validation, design control, risk management , material and molding, design validation to create ... with design verification, including but not limited to, design controls, risk management , materials & molding, process development and validation,… 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
- Insmed Incorporated (NJ)
- …with business objectivesAs the strategy evolves, prepare alternative development and risk management scenarios, project updates and options and recommendation ... matrix organization, driving decision making, facilitating issue resolution, problem-solving, risk management , contingency planning and decision-makingLead and… 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
- Ochsner Health System (Bay St. Louis, MS)
- …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 ... be self-directed and work independently.Effective planning, organizational and time management skills.Job DutiesProvides direct patient care with direct supervision… 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 System (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 (NJ)
- …expertise in root cause analysis, investigations, change control, and Quality risk management .Direct experience with clinical manufacturing, analytical ... Phase 3, ensuring compliance with GMPs and internal standards.Serve as the Quality lead for GMP activities supporting clinical trial materials, including DS/DP… 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
- Optum (Houston, TX)
- …coming in and out of the hospital, or those with life-limiting illnesses. The physician will lead the team in high- risk patient care and the transition of care ... of our vision to make healthcare better for everyone. At Optum, you'll have the clinical resources, data and support of a global organization behind you so you can… more
- Merck & Co. (Rahway, NJ)
- …Engineering, Business, Cell Cultures, Cell Line Development, Cell Line Engineering, Clinical Judgment, Communication, Flux Analysis, Human Health Risk ... achieve our goals, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing, all within a… 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. (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
