- Merck & Co. (Philadelphia, PA)
- … Management , Quality Management , Regulatory Affairs Compliance, Regulatory Change Management , Regulatory Communications, Regulatory ... management of delivery of high quality and timely regulatory submissions.The responsibilities of the incumbent may include the...Regulatory Management , Regulatory Project Management , Regulatory Strategies, Regulatory Strategy… more
- Merck & Co. (Rahway, NJ)
- …CMC regulatory strategy, risk, mitigation, and overall plan to the Regulatory Affairs, R&D, Manufacturing and GHH management teams, product development ... change support.-Minimum of (7) years of significant People Management / Leadership experience with proven track record of developing talent.-Recognized… more
- Merck & Co. (North Wales, PA)
- …RIM-based global content source management solution and function as BSOLead the Change Management and Business Process activities to drive adoption of the ... of improvement initiatives including business process design, coordination of IT activities, change management and trainingPartner with QA and Standards to… more
- Merck & Co. (North Wales, PA)
- …healthcare, or life sciences.#eligibleforERPRequired Skills: Adaptability, Adaptability, Change Management , Communication, Computer Science, Critical ... Process, Metadata Management , Policy Implementation, Process Improvement Projects, Project Management , Regulatory Affairs Compliance, Regulatory Affairs … more
- Merck & Co. (Durham, NC)
- …creating inventory transition plans to the new source of supply or for post- change supply) Risk Management Proactively identifying and mitigating risks and ... of eight (8) years' combined and diverse experience in Supply Chain Management , Operations, Technology, Regulatory , or Procurement with a demonstrated record… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …assures the quality of the material content of any documents sent to regulatory authorities. Provides compliance metrics to management , as needed.Lead continuous ... to ensure benefit-risk integration to ensure signal, epidemiological data, and regulatory requirement synthesize into a coherent risk management … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and inspections. Finally, this position has advanced skills in continuous improvement, project management , change management , and risk management . ... data review and cleaning, database lock), to ensure data quality/integrity and regulatory compliance- Ensures that Data Management Plans are consistent and… more
- BioAgilytix (Durham, NC)
- …technical concepts clearly and work cross-functionally to align data management goals with BioAgilytix's operational and regulatory requirementsDemonstrated ... checks, and setting up clear governance so everyone knows who can see or change each dataset. You'll start as a "player-coach," doing the technical heavy lifting… more
- Capital One Bank (Richmond, VA)
- …years of Financial Services industry experience, including familiarity with regulatory practicesCybersecurity and technology risk and/or project management ... Director, International Risk Management (ES Risk)Capital One is one of the...customers, shareholders and associates. Your contributions will drive organizational change through risk identification, measurement, analysis and reporting in… more
- Capital One Bank (Annapolis, MD)
- …You'll play a pivotal role in developing and driving our international risk management strategy-from day one. Teamwork is at the heart of our innovation and ... that operate within a highly collaborative team environment to deliver value-added risk management services to our Technology and Business partners. You will have a… more
- Capital One Bank (Riverwoods, IL)
- …and design of cybersecurity controlsConduct assessments and draft assessment for senior management and other stakeholders, to include regulatory agencies and the ... cybersecurity and managing technology risk. Technology & Data Risk Management (TDRM) is a small organization that packs a...within the team and across stakeholder groups.Promote and influence change in technology and program from the first line… more
- Capital One Bank (Goochland County, VA)
- …through technology, we equally prioritize cybersecurity, reliability, software quality, and data management .Technology & Data Risk Management (TDRM) is a small ... the bar for excellence in cybersecurity, reliability, and tech risk, and data management risk. We shape strategy and decisions, challenge activities to ensure they… more
- Merck & Co. (Rahway, NJ)
- …planning, integrated risk management , cost of goods projections, post approval change management and lifecycle strategies for their product(s).- As a result, ... , Strategic Thinking, Supply Chain Analytics, Supply Chain Metrics, Supply Change Management , Vendor SelectionPreferred Skills: Current Employees apply HERE… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …status, escalating issues in a timely manner for earliest resolution, Regulatory Inspections:Facilitates regulatory inspection preparation, management , and ... Medical Affairs teams and related submissions, supporting the preparation and management of regulatory inspections in collaboration with business functions.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal workflow timelines and performance metrics to ensure departmental KPIs and regulatory compliance are met Lead deviation management activities, including ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...process improvements related to patient safety. Also support case management activities within US Patient Safety Team. Relationship Reports… more
- Merck & Co. (Rahway, NJ)
- …oversight of DS & cell banking process development, process characterization and regulatory filing activities to ensure a smooth and clear path to successful ... control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions.CMC RA: Experience supporting/writing regulatory filings… more
- Merck & Co. (Rahway, NJ)
- …Drug Development, Good Clinical Practice (GCP), Nursing, Patient Education, Quality Management , Quality Standards, Regulatory Compliance, Regulatory ... Requirements, Regulatory Submissions, Risk Based Monitoring, Risk Management , Strategic Planning {+ 4 more}-Preferred Skills:Job Posting End Date:10/6/2025 *A… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … change agent to promote flexibility, creativity, and accountability.Project management skills, responsiveness to issues, and demonstrated passion for creating ... Associate Director, Senior Manager, and Manager.Oversee the hiring, development, and performance management of staff in a growing operation in terms of volume/output… more
- Merck & Co. (Rahway, NJ)
- …Driving License:NoHazardous Material(s):n/aRequired Skills:Applied Engineering, Applied Engineering, Change Management , Combination Products, Compliance ... distribution and logistics of finished goods images, encompassing proactive risk management strategies, platform standards for standard finished goods images and… more
- Merck & Co. (Rahway, NJ)
- …- DayValid Driving License:NoHazardous Material(s):n/aRequired Skills:Applied Engineering, Change Management , Combination Products, Compliance Packaging, ... distribution and logistics of finished goods images, encompassing proactive risk management strategies, platform standards for standard finished goods images and… more
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