- Daiichi Sankyo, Inc. (Bernards, NJ)
- …across the clinical development in cross functional teams.Builds partnership with safety programming teams, project statistical teams, and internal cross ... leadership and guidance as the lead statistician dedicated to safety on one or more safety monitoring...studies and compound level pooled clinical trial data of project (s). Act as statistical expert consultant within company for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(PV) oversight. This role fulfills the PV Oversight for NNI Patient Safety processes and as providing SME-level input from the affiliate perspective when ... relationship to business improvement projects. Interact closely with NNI Patient Safety and NAO Quality Audits & Inspections. External relationships include… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …& the business through serving as a process champion for an assigned special project as needed Follow all safety & environmental requirements in the performance ... verbal, presentation. Impact & influence preferred Analytical skills preferred Project management skills preferred Knowledge of Lean Manufacturing applications in… more
- Merck & Co. (Durham, NC)
- …compliance.Support the Master Data team with general Material Handling Steward tasksDrive safety , quality and process enhancements throughout the supply chain - ... Project Management Lead and sponsor all Supply Chain Logistics...storage needs/capacity.Collaborate with EHS team to ensure all departmental safety and training requirements are met, related to any… more
- Merck & Co. (Rahway, NJ)
- … Safety & Environmental Policies and Procedures.Familiarity with Capital Project systems (administration and execution) as well as Computerized Maintenance and ... will be to maintain all equipment in accordance with GMP and Safety requirements, as well as exercising Reliability Maintenance best practices to ensure… more
- Merck & Co. (Rahway, NJ)
- …Process Safety for Small Molecule High Potency/Containment Projects. Develop project scope, front-end planning, and provide innovative designs and solutions that ... Safety Devices, And Other Relevant Pharmaceutical Unit OperationsCapital Project Experience, Including Adherence to Schedule and Budget for Deliverables,… more
- Merck & Co. (North Wales, PA)
- …the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings, figures), the span of ... multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.The position is a key collaborator with statistics and other… more
- Merck & Co. (North Wales, PA)
- …the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings, figures), the span of ... stakeholder groups which include clinical development, outcomes research and safety evaluation. - The position is a key collaborator...position is a key collaborator with statistics and other project stakeholders in ensuring that project plans… more
- Merck & Co. (Rahway, NJ)
- …to strategic initiatives; work with senior leaders to establish overall project strategy and guide teams in its execution.Conceptualize, plan, and execute ... BPR&D as a upstream bioprocess expert/co-leader in internal and cross-functional project teams.Supervise, coach, and develop talent within the functional area; guide… more
- Novo Nordisk Inc. (Durham, NC)
- …from wide variety of data sources Support manufacturing, business, and project departments with process understanding, analyses, and systematic problem solving ... main areas of Systematic Problem Solving, process improvement, & project management Serve as the Lead and SME to...tools when relevant Lead in the following of all safety & environmental requirements in the performance of duties… more
- Merck & Co. (Durham, NC)
- …opportunity for a Specialist to join the operations team supporting a capital project critical to Human Health at our facilities in Durham, North Carolina. This ... stakeholders across MPS, GES, and across site for informationIndependently manage project assignments, escalate potential delays and develop remediation plans when… more
- Merck & Co. (Durham, NC)
- …people that make our products. We work in the manufacturing plants with a " Safety First, Quality Always" mindset striving for continuous improvement. We work in the ... monitor performance of instruments and be able to identify trends.Work with project personnel to ensure appropriate instrument turnover to site.Expand knowledge into… more
- Eisai, Inc (Nutley, NJ)
- …Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good ... eTMF assist with set-up requests andAssists with filing and archiving project documentation in the eTMF within the defined timelinesPerforms eTMF internal… more
- Merck & Co. (Durham, NC)
- …to deliver Pharmaceutical, Biologic, and Vaccine Products. Our team works with a " Safety First, Quality Always" mindset.-As the primary point of contact for all ... External Partner).-- Compliance:-Achieve compliance goals through a risk-based approach ( Safety Regulations, Quality Assurance, Risk Management, Deviation Management, Product… more
- Merck & Co. (Rahway, NJ)
- …thinking to advance ADC, Complex Biologics and Small molecule portfolio. Project management skillsAttention to technical detailBuilds collaborations across internal ... writing / review of regulatory filings including INDs and NDAs.Exposure to project / engineering work process and deliverables (eg equipment fabrication, FAT, SAT,… more
- Merck & Co. (Durham, NC)
- …well-being, and performance.- We are a global team of Environmental Health and Safety (EHS) professionals working collectively within the company to make a positive ... best practices, investigate and mitigate risks across environmental, health, safety , and sustainability (EHS&S) opportunities.- Ensure comprehensive change management… more
- Aequor (Tampa, FL)
- …and finished products. Support QC chemist to provide the method technology transfer and project preparation work, make sure the project runs on time and ... responsibilities to support the business as requested. Adhere to all defined Safety and Sustainability requirements and expectations and seek clarification whenever … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Interacts closely with Marketing & Patient Support Solutions and NNI Patient Safety . External relationships include interactions with NNI vendors involved in the NNI ... of the NAO Quality PV Oversight vendor assessment plan for NNI Patient Safety Accountable for alignment between vendor assessment team and NNI Patient Safety… more
- Eisai, Inc (Nutley, NJ)
- …and successful execution of clinical studies in accordance with the overarching project plans established by the various International Project Team Leaders ... quality, and successful execution of clinical studies in alignment with project plans established by IPTLs.Oversee the TMF department, ensuring the management,… more
- Merck & Co. (Rahway, NJ)
- …is responsible for providing strategic leadership, technical expertise, and project management in the scale-up, development, commercialization, and transfer of ... quality and regulatory compliance.-Essential Duties and Responsibilities:Strategic Leadership and Project Management:Provide leadership in the development, commercialization, and transfer… more
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