- Merck & Co. (Rahway, NJ)
- …Project Management , Project Portfolio Management (PPM), Publications Management , Regulatory Compliance, Risk Management , Sourcing and Procurement, ... and external to GCS and serve s as the lead GCS spokesperson at clinical and development...with stakeholders at various levels, including cross-functional teams, senior management , external vendors, and clinical sites. Strong… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate ... Modality, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and development… more
- Formation Bio (New York, NY)
- …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 ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Merck & Co. (North Wales, PA)
- …planning, feasibility, and execution of a clinical trial.May serve as the clinical trial team leadMay lead team in key study planning, development, and ... of status update reports, study close out activities).Leads team for timeline management , risk identification and mitigation, issue resolution.May facilitate and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Finally, this position has advanced skills in continuous improvement, project management , change management , and risk managementResponsibilities: Leadership, ... BDM functions, sets the vision, direction, and strategy for Clinical Data Management globally and ensures execution... globally and ensures execution of the global data management strategy across regions and across studies/programs. Lead… more
- Merck & Co. (San Francisco, CA)
- … Process, Managing Engineering Teams, Operational Metrics, Performance Monitoring, Project Management , Research Databases, Risk Management , Status Reporting, ... partner with the DSCS Digital Leadership Team to drive the execution and management of DSCS Digital initiatives.Development Sciences and Clinical Supply (DSCS)… more
- Merck & Co. (Rahway, NJ)
- …Staff, Performance Monitoring, Personal Initiative, Project Scheduling, Resource Allocation, Risk Management , Stakeholder Management , Vision ... Work Arrangements:HybridShift:Valid Driving License:Hazardous Material(s):Required Skills:Budget Development, Business, Change Management , Clinical Trial Management , Communication,… 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
- Merck & Co. (Rahway, NJ)
- …regional and local strategy in line with the global strategy, including supplier management , compliance, risk management , diversity spend, and stakeholder ... Skills, Procurement, Procurement Management , Production Planning, Project Procurement Management , Regulatory Compliance, Risk Management , Stakeholder… 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
- Merck & Co. (Rahway, NJ)
- …launch planning tool, ensuring adherence to timelines, budgets, and resource allocation. Risk Management : Identify potential risks and interdependencies across ... Driving License:NoHazardous Material(s):n/aRequired Skills:Adaptability, Adaptability, Agile Methodology, Agile Project Management , Biopharmaceuticals, Biotechnology, Business, Clinical Immunology, Communication,… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …consistently and proactively represented at program level and support proactive quality risk management process.Interact with the audit and compliance function ... of MA risks identified through audits, inspections, internal meetings, remediation and risk management in close collaboration with the organization's quality … more
- Aequor (Thousand Oaks, CA)
- …and implement the NPI project plan(s), being accountable for NPI scope, schedule, risk management , and leading matrixed teams through influence to meet NPI ... Manufacturing" role will serve as a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems,...vital to the impact that ATO B20 with a clinical and commercial product mix has to the network.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requires skills in working in a fast-paced environment, continuous improvement, change management , and risk management . Experience working and managing ... immune disorders. Summary: The Senior Director, Head of RBQM ( Risk Based Quality Monitoring) sets the vision and strategy... factors with and for other technical departments (eg, Clinical , Medical, Safety, Data Management , Statistics). This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tailored for AEs from end-to-end: understanding predisposing non- clinical and clinical factors, diagnosis, effective management during clinical trials ... of Functional Excellence, across key functions to improve the benefit- risk in patients treated within the oncology compounds throughout...remains top of mind in the context of patient management in the clinical trial setting and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …updates from the drug side, as needed. Provide RA specific inputs into CDx Risk Management plans for individual projects/indications. Assist the CDx team with ... to external diagnostic business partners specifically:Use of CTA/CDx within clinical trialsDevice protocols and SAPsDevice non-significant/significant risk … more
- Insmed Incorporated (San Diego, CA)
- …will play a key role within the Manufacturing Sciences Department, supporting clinical GMP drug substance and drug product production and quality control operations. ... This role combines technical leadership in equipment lifecycle management with oversight of calibration and maintenance systems to ensure operational readiness and… more
- Merck & Co. (Rahway, NJ)
- … Management , Pharmaceutical Process Development, Process Scale Up, Program Risk Management , Project Planning, Protein Characterization {+ 2 more}-Preferred ... high yields along with superior product quality and allow speedy progression for clinical studies and commercial launch. The candidate will be a member of the… more
- Merck & Co. (Rahway, NJ)
- …SM PR&D pipeline. Responsibilities: Under the scientific direction of a facility lead , the Operations Specialist will participate in equipment setups, raw material ... aiding technology development, and supplying Active Pharmaceutical Ingredient (API) for clinical use and drug product development. This will involve handling of… more
