- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Safety 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
- buyer (Von Ormy, TX)
- …our Registered Nurses (RN)s works together to make sure we achieve outstanding clinical outcomes. Aveanna isn't just a provider of compassionate homecare to children ... in patient needs and responses requiring intervention and implements care to prevent risk or reduce risk .* Accepts responsibility for personal and professional… 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 ... the effects of case management on the patient population.Create outcomes- management focus by interdisciplinary analysis of specific clinical , financial and… more
- DERMCARE MANAGEMENT LLC (Orlando, FL)
- …protocols. Willingness to learn and adapt to new responsibilities, including cross-covering clinical risk management tasks. Compassionate, patient and a ... regular inspections, and coordinating cleaning services. Assist and cross-cover the Clinical Risk Manager's responsibilities after training, including peer… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …has advanced skills in continuous improvement, project management , change management , and risk management . Responsibilities Leadership, Direction, and ... as well as other BDM functions, sets the vision, direction, and strategy for Clinical Data Management globally and ensures execution of the global data … 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 ... signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily strategic initiatives to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …systems and processes of the Daiichi Sankyo's GxP group.Together with regional management teams plans, will support, conducts and reports internal systems and ... of GxP audits assigned in alignment with the Master Audit Schedule using a risk -based approach to ensure the Audit Plans are aligned with the company's strategy and… more
- Merck & Co. (Rahway, NJ)
- …globally across Global Regulatory Affairs CMC (Global Regulatory Affairs & Clinical Safety), Research and Development (R&D), Manufacturing, and Global Human Health ... solid-oral small molecules and includes pre-approval regulatory strategy and submissions (global clinical and marketing applications such as IND, CTA, NDA, and MAA)… more
- Merck & Co. (Rahway, NJ)
- …will participate in case processing and reporting, support aggregate reporting and risk management activities, help maintain PV databases and documentation, and ... review aggregate adverse event reports and maintain aggregate report schedules- Support risk management data acquisition and related activities- Track team… 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
- The Career Sphere (Escondido, CA)
- …staff, reviewing and participating in quality assurance activities, and directly overseeing clinical safety and risk management .The medical director serves ... facility develop and manage both quality and safety initiatives, including risk management .Role 4 Education, Information, and CommunicationThe medical director… 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, ... Commitments, Critical Incidents including, respective escalation and the CAPA Management Process for the respective business areas.Responsibilities:Leadership and Project… 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
- Insmed Incorporated (San Diego, CA)
- …teams and senior leadership, as neededCollaborate with Clinical Development, Clinical Operations, CMC, QA/QC, Nonclinical, Program Management , and external ... regulatory competitive landscape to identify potential opportunities and areas of risk to assigned programsProvide strategic regulatory guidance and input in problem… 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 ... for strategic initiatives and capacity expansion activities at the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will partner… 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)
- …biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical manufacturing plant in Rahway, New Jersey. The Sterile Production ... members and partner groups including formulators, engineers, Quality, Safety, and Facilities management to drive overall success and performance of the area and … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. This ... Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process.Support manufacturing activities for cGMP compliance through spot… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... issues, and process improvements related to patient safety. Also support case management activities within US Patient Safety Team. Relationship Reports to the Head… more
