- Daiichi Sankyo, Inc. (Bernards, NJ)
- …case no Sr CMC Lead is established, take main responsibility for CMC lead . Provide operational coordination and management to drive strategies and ... budget, timeline, achievement of defined milestones and overall project risk management . He/she will assess project issues...responsible for regional and global process improvements in the operational efficiency of PJ Lead and Tech… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you ready to experiment with us? The Position The therapeutic area Operations Lead is responsible for supporting the therapeutic area One Impact Planning process, ... the business. Relationships Reports to the US Integrated TA Strategy Lead . Collaborates closely with cross-functional teams, including sales, marketing, medical… more
- Aequor (Thousand Oaks, CA)
- …Role and Responsibilities Manage multiple cross-functional raw material onboarding, life cycle management , and operational excellence projects of medium to high ... risk and resources of the work being managed. Lead continuous improvement projects that deliver measurable gain in...within . Apply the knowledge, skills, tools of project management / Operational Excellence (OE) to ensure… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provide updates, ensure alignment and monitors vendor activities Leverages knowledge of risk management standards for current processes, projects, and systems ... core operations and develop insights to drive growth and operational excellence across the value chain while innovating for...with us? The Position The "Senior Architect - Data Management & AI" is a technical leader with a… more
- Merck & Co. (Upper Gwynedd, PA)
- …preparing for, management and follow up of regulatory inspections.Primary Responsibilities: Operational Quality Management Develop Risk Assessment and ... and worldwide Regulatory Health Authority requirements.Experience with delivering effective CAPA management solutions.Experience with risk management tools… more
- Tris Pharma (Monmouth Junction, NJ)
- …implement improvements, including CAPAs and CPIs, across departments as appropriateApplies quality risk management principles in the design (and resolution) of ... New Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management Systems (QMS) supports,… more
- Merck & Co. (Rahway, NJ)
- … Units (OpUs) as it relates to in-line product management , supplier management , risk management and savings identification.Works closely with DMLT ... while remaining a financial steward.Scope:-Responsible for all in-line product execution, risk management and escalation.-Emphasis on matrix management … more
- Merck & Co. (Rahway, NJ)
- …Company policy. The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate ... Sterile Product Development (SPD) team. The successful candidate will be expected to lead the team focused on the design of new formulations and development of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requirements, and industry best practices.Ensure /support the development of GLP/GCLP systems, risk management processes such as SOPs for QA activities for ... aligned GCLP/GLP strategy across DS teams. Establishes and / or develops operational resource strategy to determine the extent of resources needed to deliver… more
- Merck & Co. (Rahway, NJ)
- …and resolve anomaliesEnsure compliance with all corporate and departmental IT risk management policies and practices Intellectual property (IP) Technology ... points, and implementing solutions that meet stakeholder's expectationsExcellent project management skills with experience improving operational efficiencies… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …delivery and coordinates legal review of finalized contract Understands and applies risk management practices: Ensures departmental project and QA requirements ... core operations and develop insights to drive growth and operational excellence across the value chain while innovating for...handed over to responsible units, such as IT Systems Management , to manage future lifecycle of the solution Negotiate… more
- BioAgilytix (Durham, NC)
- …project plans, timelines, and budgets using Smartsheet to ensure smooth project execution. Risk & Issue Management : Identify and resolve project risks, issues, ... implementation, customization, and optimization of the LabVantage Laboratory Information Management System (LIMS). This onsite role requires close collaboration with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …consultant and implementer for the SVP, planning and directing all key operational , financial, and administrative activities. This role actively participates as a ... Sets the framework and strategy and best practices for therapeutic brand planning Lead the Marketing budget follow-up process to ensure full transparency and optimal… more
- Merck & Co. (Rahway, NJ)
- …regulatory requirements throughout the product design, development, and manufacturing processes.Implement risk management principles (ISO 14971) in design and ... 4). Lead quality oversight of product validation, verification, and risk mitigation activities.Regulatory CMC OversightLead the preparation and submission of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management , Quality Assurance, Medical Affairs, Translational ... Research, Research, Informatics Services, Project Management and Operational Management . Develop...Responsible for Strategic Application product roadmaps to meet business objectives. Lead the definition of solutions based on business needs,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams, agencies and healthcare associations to develop and implement congress operational programs, budgets and tactics for the successful and compliant execution ... of all congresses.Responsibilities- Congress Planning and Execution Management - Manage the planning and onsite execution for the global and national congresses.-… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …safety reporting regulations, Health Canada regulations ICH guidelines and the management of contracts with safety reporting requirements. Key contact person for ... Safety Assessment activities through product development, product maintenance and lifecycle management Ensure Signal Management processes and activities are… more
- Merck & Co. (Rahway, NJ)
- …and leadership skills.Project management experience including resource management , budget forecasting, and risk assessment/mitigation planning.Comfort with ... within the Development Sciences and Clinical Supplies (DSCS) organization and lead a group of exceptionally talented scientists supporting externalized analytical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …QualifiedPossess the ability to positively influence peers, key stakeholders and management .Generates shift schedules, to ensure efficient coverage for all ... operational needs.Maintain individual training completion in a compliant state.Supports the completion of corrective and preventive actions, as necessary.Supports… more
- Discover (Riverwoods, IL)
- … and control statements. + Supports the business with developing requirements for the effective management of operational risk events. + Implements risk ... Engineering or related + 2+ year experience in Compliance, Internal Audit, Business, Risk Management , Financial Services, Process Improvement or related + In… more
