- 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
- Insmed Incorporated (NJ)
- …by Technical Operations or from CMOs to support development program and life cycle management , and ensure they meet current regulatory standards, are of high ... successful development of CMC submission packages to support product life cycle management .Work effectively with regulatory colleagues and continuously improve … 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …where your distinct perspectives and expertise are valued as we work together to change lives for the better. The Position The Director, Media Relations & Issues ... Management is accountable for establishing and leading Novo Nordisk's...Affairs, Legal, Finance and Investor Relations, Clinical, Medical and Regulatory , plus other cross functional teams as needed. Key… more
- Capital One Bank (Newport News, VA)
- …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 (Williamsburg, 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 (Norfolk, VA)
- …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 (Petersburg, 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
- 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
- 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
- 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
- Capital One Bank (Norfolk, VA)
- …and cyber impacts.Implement process improvements: process certification framework, process hierarchy change management , change control, and risk reporting ... and highly skilled professionals. We operate at the forefront of risk management , providing support for novel and developing technologies, as well as critical… more
- Merck & Co. (Millsboro, DE)
- …industry technical business processes:- change control, deviation management , technical protocols/reports, and regulatory license documents.-Current ... and other stakeholders to ensure effective communication for scoping, planning and change management .Stay abreast of scientific developments and trends in… more
- Merck & Co. (Rahway, NJ)
- …and represent the company externally to influence industry standards and regulatory practices.-Primary Scientific & Leadership Requirements - HF Influence Serve as ... coach to the HF team and key stakeholders across R&D, clinical, regulatory , marketing, manufacturing, and quality functions.Educate and build awareness of HF… more
- Insmed Incorporated (NJ)
- … change controls, and protocols/reports.Collaborate cross-functionally with CMC team, Regulatory , Clinical Operations, and Program Management to drive ... management experience.Proven expertise in root cause analysis, investigations, change control, and Quality risk management .Direct experience with clinical… more
- Capital One Bank (Fredericksburg, VA)
- …of payments network operations and ecosystem related risks, as well as risk management and regulatory expectations for a large financial institution. This role ... and concise audit reports. Communicate the results of audit projects to management via written reports and compelling oral presentations. Provide significant input… more
