- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …matter experts (SMEs), and other functional area partners to ensure GCO risk management activities are executed and continuously monitored for effectiveness, ... to ensure a continued practice centered on Quality by Design, Clinical Trial Risk Management , efficient Issue Management , and Continuous Improvement.Supports… more
- Merck & Co. (Rahway, NJ)
- … Management - Supply TransitioningDefining key business requirements (validation, regulatory filing, inventory builds, and creating inventory transition plans to ... of eight (8) years' combined and diverse experience in Supply Chain Management , Operations, Regulatory , or Procurement with a demonstrated record of… more
- Merck & Co. (Rahway, NJ)
- …equivalent.Expertise in electronic data capture software dedicated to the Data Management process.Ability to understand and implement regulatory regulations and ... However, some common responsibilities and functions include:Write study-specific data management plans and reports.Develop and maintain databases to collect and… more
- Novo Nordisk Inc. (Stamford, CT)
- …integrity; regulatory and process compliance) for monitoring and site management activities. Takes ownership to deliver upon near-term North America Clinical ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Director, Global Clinical Operations (GCO) Procedural Ownership and Life Cycle Management , will be accountable for the authoring and lifecycle management ... GCP standards. The Associate Director will also be responsible for the creation, management , and documentation of GCO's CRO SOP review and maintaining the master… more
- Merck & Co. (North Wales, PA)
- …for related drug/vaccine projects in Late Development Statistics.Interacts with Clinical, Regulatory , Statistical Programming, Data Management , and our company's ... results of clinical trials to the project team, our company's Management , regulatory agencies, or individual investigators.Provides responses to queries… more
- Eisai, Inc (Nutley, NJ)
- …stakeholders from EIT and leaders across regions in Compliance, Ethics, Risk Management , Legal, Data Privacy, and Information Protection.Security ... compliance requirements across relevant jurisdictions.Update IT compliance policies based on regulatory changes.Establish a regulatory change management … more
- Merck & Co. (Rahway, NJ)
- …to the broader Merck Corporate strategy.-In addition, GPAM includes a Project Management Office (PMO) which is responsible for the development, sustainment, ... skills used in drug development through assisting in ensuring project schedules and risk management plans are fully developed and updated, governance contracts… more
- Insmed Incorporated (San Diego, CA)
- …functional and cross-functional teams and ad hoc project team meetings Conducts the risk management and scenario planning and develops contingency and/or risk ... etc.) 5-7 years of Project/Program Management experience with proven management and/or leadership experience in an R&D, Regulatory , manufacturing/operations… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including merit ... launch.- The successful candidate will be responsible for resourcing planning, risk assessment strategies, talent development, and partnering to build a culture… more
- BioAgilytix (Durham, NC)
- …system and equipment validations follow national and international GxP standards, as well as regulatory requirements such as 21 CFR Part 11, Annex 11, Annex 15, and ... a core resource for collecting and documenting requirements for a risk -based validation approach, ensuring thoroughness and accuracy in documentation. Conduct… more
- Merck & Co. (Rahway, NJ)
- …(including the CTC, CRAs and-COM).-- Responsible for creating and executing a local risk management plan for assigned studies.- Ensures compliance with CTMS, ... role is primarily accountable for the end-to-end performance and project management for-assigned protocols in a country in compliance with ICH/GCP and… more
- Merck & Co. (Rahway, NJ)
- …(including the CTCs, CRAs and COMs).Responsible for creating and executing a local risk management plan for assigned studies.Ensures compliance with CTMS, eTMF ... TA-Head/CRD, this role is accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with-ICH/GCP and… more
- Merck & Co. (Rahway, NJ)
- …external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and ... reporting and interpretation of dataMaintain a comprehensive understanding of global regulatory expectations and shape, present and defend regulatory documents… more
- Merck & Co. (North Wales, PA)
- …and interests from the world's biomedical literature in support of regulatory , clinical research, marketing, and legal functions.- Plans, organizes, monitors, ... Develops, with input from internal stakeholders and knowledge of current regulatory requirements, article selection, adverse event reporting, editorial, and indexing… more
- Merck & Co. (Rahway, NJ)
- …Development. -The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including merit ... The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering… more
- Merck & Co. (North Wales, PA)
- …& Development Division sites and requires reporting in to an office 3 days a week (hybrid).Responsibilities-and Primary ActivitiesLeadershipUnderstands the mission ... with internal and external stakeholders at all levels, including senior management and vendor partnersPossesses a strong understanding of relevant regulatory… more
- Merck & Co. (Rahway, NJ)
- …and scientists within Discovery, Pre-clinical Development, Manufacturing, Quality Assurance and Regulatory groups and provides technical insights and support for our ... in a timely manner needed to meet project milestones and associated regulatory requirements. This includes development of novel methodology and processes to position… more
- Merck & Co. (Rahway, NJ)
- …core enterprise manufacturing functions. This includes the Strategy and Portfolio Management office , Global Supply Business Development (GSBD) which evaluates ... social complexities and integrate to project plans.-Experience in Relationship Management , Operations, Technology Transfers, Regulatory , Procurement, Capital… more
- Aequor (Seattle, WA)
- …the Cell Therapy Development (CTD) Development Operations & Services (DO&S) Portfolio Management Office . This individual will be responsible for overseeing the ... Develop and maintain detailed CMC project plans, including resource allocation, risk management , and timeline tracking. Facilitate cross-functional CMC… more
