- Merck & Co. (Rahway, NJ)
- …experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement experience ... System Associate for the Labeling Operations area within the GRACS Regulatory Innovation & Information Management organization.Primary area of responsibilities will… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:The Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory ... strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.Contributing to the continuous improvement of the… more
- Merck & Co. (Rahway, NJ)
- …design and development, manufacturing process development, qualification, validation, and design control and risk management techniques to positively support and ... Development, Product Development, Product Lifecycle Management (PLM), Project Management, Regulatory Interactions, Regulatory Oversight, Risk Management,… more
- Merck & Co. (Rahway, NJ)
- …management, FMEA, design verification, design validation, statistical sampling, and control strategyExperience with regulatory fillingsWorking knowledge of ISO ... from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This position will interact… more
- Merck & Co. (Rahway, NJ)
- …products.Technical Expertise:Utilize extensive experience in design controls, device transfer, control strategies device risk management, and design verification ... in both development and lifecycle management, ensuring compliance with relevant regulatory standards.Ensure robust technical plans, risk communication, drive… more
- Aequor (East Syracuse, NY)
- …in the biopharmaceutical development process, GMP, PAT, CMC and regulatory guidance, ICH guidelines, and compendial requirements is desired.Experience authoring, ... coordinating timely transfer of test methods with and to Quality Control laboratories is desired. Specific Knowledge, Skills, Abilities, etc.Strong written, verbal,… more
- Merck & Co. (Rahway, NJ)
- …. - Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply related ... products and non-our company marketed products . - Analyzes and anticipates project risk s as they relate to clinical supply chain deliverables and prepares ,… more
- Merck & Co. (Rahway, NJ)
- …Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance, Risk Management, Sourcing and Procurement, ... as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines ,- strategies… more
- Merck & Co. (Rahway, NJ)
- …of Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and ... The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering… more
- Merck & Co. (Rahway, NJ)
- …expertise to optimize and fully characterize the enzyme manufacturing process control strategy across different scales.The successful candidate will play a pivotal ... candidate will provide scientific expertise by learning and utilizing Quality Risk Management methodologies and tools for statistical design of experiments. This… more
- Aequor (Thousand Oaks, CA)
- …of DP technical process, manufacturing operations, scientific method, basic regulatory compliance expectations, and quantitative / analytical troubleshooting skills. ... and implement the NPI project plan(s), being accountable for NPI scope, schedule, risk management, and leading matrixed teams through influence to meet NPI project… more
- Merck & Co. (Rahway, NJ)
- …of clinical development, as well as process characterization and regulatory filings for successful commercialization.Improve upstream processes by increasing ... prioritization, and problem-solving skills.Stay updated on the scientific and regulatory landscape; contribute scientifically and build your reputation through… more
- Merck & Co. (Durham, NC)
- …goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management, Deviation Management, Product Release, Change Control ).- Supply ... provide Operations input into Supply and Quality Agreements.- Launch Supply Risk Mitigation:-Ensure External Partner Site Readiness, Assist with Technology Transfer,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and QMS records.Build the Site Readiness of MES for FDA and/or Other Regulatory Audits / Inspections.This individual is responsible for the training of Manufacturing ... cGMP manufacturing and project planning experience preferred.Provide technical expertise of Change Control process as well as oversight of the MES team to ensure… more
- Wells Fargo (Phoenix, AZ)
- **About this role** **: Wells** Fargo is seeking talent to join the Business Risk Control and Regulatory Oversight team under the Chief Operating Office ... business at wellsfargojobs.com (https://www.wellsfargojobs.com/career-areas/) . **Business** **Overview:** The Business Risk Control and Regulatory Oversight… more
- Navy Federal Credit Union (Vienna, VA)
- …multi-faceted projects with cross-departmental impact + Advanced knowledge of operational and regulatory risk control concepts and practices + Proven ... and present to management and/or affected business unit summaries, operational and regulatory risk assessment reports, trending, and remedial or mitigation… more
- System One (Ashburn, VA)
- …projects simultaneously that have cross-departmental impact *Advanced knowledge of operational and regulatory risk control concepts and practices *Proven ... and present to management and/or affected business unit summaries, operational and regulatory risk assessment reports, trending, and remedial or mitigation… more
- Navy Federal Credit Union (Vienna, VA)
- …simultaneously that have cross-departmental impact + Significant knowledge of operational and regulatory risk control concepts and practices + Proven ... and present to management and/or affected business unit summaries, operational and regulatory third-party risk assessment reports, trending, and remedial or… more
- Shuvel Digital (Pensacola, FL)
- …projects simultaneously that have cross-departmental impact + Advanced knowledge of operational and regulatory risk control concepts and practices + Proven ... and present to management and/or affected business unit summaries, operational and regulatory risk assessment reports, trending, and remedial or mitigation… more
- HSBC (Buffalo, NY)
- …drive completion of control testing assignments to support operational, conduct and regulatory risk & control management + Effectively Delegate work ... in any discipline with strong academic background + Experience in control testing and risk management, internal control , or internal audit preferably within… more
