- Insmed Incorporated (NJ)
- …the integration of new technology and processes to enhance patient safety and benefit risk management . The ED will provide day-to-day leadership and guidance to ... the Medical Safety Strategy and Benefit- Risk Management group within DSPV to ensure...expert safety review input into all critical documents for clinical development of products including protocols and amendments, ICFs,… more
- 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
- Insmed Incorporated (NJ)
- …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 ... developing and executing strategic plans for production, packaging, distribution, and clinical supply budgeting. The Director provides strategic leadership for … 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
- 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
- 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. (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
- Insmed Incorporated (NJ)
- …expertise in root cause analysis, investigations, change control, and Quality risk management .Direct experience with clinical manufacturing, analytical ... change controls, and protocols/reports.Collaborate cross-functionally with CMC team, Regulatory, Clinical Operations, and Program Management to drive proactive… 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
- Insmed Incorporated (NJ)
- …EMA, and ICH regulatory requirements. This role will support implementation and ongoing management of digital systems used in clinical trial operations, quality ... Good Clinical Practice (GCP) E6(R3), Computerized Systems Used in Clinical Trials, Computer System Validation, Quality Management Systems ProcessesWho You… 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
