- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study teamsDevelop best practices and lessons learned mechanisms within Clinical OperationsDevelop risk assessment & risk management and clinical ... each CRO to best support each program. This position will require line management responsibility of Directors, Associate Directors, Clinical Study Managers, who… more
- Merck & Co. (Rahway, NJ)
- …Management , Quality Standards, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions, Risk Based Monitoring, Risk Management , Strategic ... Arrangements:RemoteShift:Not IndicatedValid Driving License:YesHazardous Material(s):NoRequired Skills:Adaptability, Adaptability, Business Processes, Clinical Data Management , Clinical Research,… 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
- The Career Sphere (Fargo, ND)
- …improvement policies and trains employees on these policies. Accountable to follow up with risk management and training of clinical staff as needed. ... no weekends or major holidays. Job Summary The Registered Nurse in the Clinical Care Leader (CCL) role facilitates health care services for patients in cooperation… 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
- 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
- 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 ... Integrated Risk Management (IRM) Identifying and raising issues and conflicting agendas/priorities for quick resolution Being able to align teams to solve… 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
- 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
- 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
- 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
- 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
- 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)
- …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. (Rahway, NJ)
- …(small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant under construction in Rahway, New Jersey. The y ... representatives, and other team members to ensure the quality and safe delivery of clinical supplies . Once the MACS Center is operational , additional tasks could… 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
- CHRISTUS Health (Arp, 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
- UNC Health (Chapel Hill, NC)
- …to advise management and departmental stakeholders on compliance issues and risk . -Must have advanced ability to listen carefully and follow directions. The ... of the unique communities we serve.Summary:Responsible for assisting Compliance management in all compliance activities which could include reviewing internal… 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
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