- Merck & Co. (Rahway, NJ)
- …to device systems. Strong analytical and statistical skills with experience in data interpretation and risk assessment tools. Excellent communication, ... risk management decisions and strategies.Utilize statistical methods to interpret risk data , providing clear and actionable recommendations rooted in… more
- Merck & Co. (North Wales, PA)
- …of `quality by design` principles in assigned clinical trials.The CQOM will develop Risk Assessment and Categorization Tools and Quality Plans in partnership ... and Acquisitions (M&A), Operations Support, Pharmaceutical Management, Quality Management, Regulatory Inspections, Regulatory Submissions, Risk Assessments,… more
- Insmed Incorporated (NJ)
- …in compliance with regulatory requirements. Develop/provide input to product Benefit- Risk Assessments, Company Core Data Sheet, Investigator's Brochure and ... and risk communication for assigned development products; perform medical assessment of individual adverse event reports generation; and review aggregate reports… more
- Cipla (Fall River, MA)
- …submission while closely working with regulatory teams. Prepare and review risk assessment (FMECA) for various facility, equipment, process and particular ... requirements. Ensure that the company remains compliant with all regulatory requirements (eg, FDA, ICH, EMA). Support risk...event etc. Prepare and review elemental impurities risk assessment and nitrosamine related … more
- Merck & Co. (Durham, NC)
- …Management, Quality Management Systems (QMS), Quality Metrics, Quality Risk Assessment , Quality Risk Management, Regulatory Compliance Consulting {+ ... and perform the operational aspects of the audit program, apply risk -based principles, communicate results to stakeholders, and evaluate/verify CAPA closure.-… more
- Bayer (Whippany, NJ)
- …(eg, Core Data Sheet, Periodic Safety Update Report, clinical benefit- risk assessment for license renewals) for the compound(s);Lead the matrix-management ... and to interpret, discuss, and present clinical trial or section program-level data ;Proven experience with FDA regulatory requirements and ICH GCP guidelines… more
- Merck & Co. (Durham, NC)
- …DiagramsLean Six Sigma belt certificationExperience with process risk assessment toolsExperience with responding to regulatory questions with multiple ... process understandingAuthor, review, and/or edit technical documents to support regulatory filings including technical reports and risk assessmentsAuthor… more
- Merck & Co. (Rahway, NJ)
- …exploring alternative ways to view and solve problems to achieve results Drive proactive risk management activities, including risk assessment , risk ... drug substance and drug product container closure systems including mold qualification and regulatory compliance.- To act as master data stewards and support… more
- Merck & Co. (Rahway, NJ)
- …Maintains a state of inspection readiness. Performs proactive resourcing planning and risk assessment strategies. Advances a culture of scientific excellence, ... and external audits. Leads microbiological investigations Review and approval of data and reports. SOP development. Quality System experience. Thorough working… more
- Bayer (Myerstown, PA)
- …support process optimization and troubleshooting.Contribute to the development of project risk assessment , technical success criteria, Target Product Profile ... assigned technology.Stay updated with industry trends, technological advancements, and regulatory requirements relevant to the assigned technology.Lead scale up of… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …lead preparation of regulatory submissions (eg, pre-IND, IND, BLA).Contribute to risk assessment of new and ongoing programs, including off-target effects, ... strategic Senior Director of Toxicology to lead and oversee all nonclinical safety assessment activities for our cell and gene therapy programs. This individual will… more
- Merck & Co. (Rahway, NJ)
- …drug product, finished goods including combination products, and samples. Drive proactive risk management activities, including risk assessment , risk ... and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership and make… more
- Bayer (Whippany, NJ)
- …development and configuration of AI including implementation of controls. Performs a formal risk assessment based upon the intended use and configuration of AI. ... via enhanced strategic USMA Governance, proactively oversees the local Legal-Medical- Regulatory approval procedures and ensures maximal effectiveness while mitigating… more
- Formation Bio (New York, NY)
- …guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of quality risk assessment and management methodologies, with a successful track ... implement a comprehensive quality assurance strategy that ensures compliance with regulatory requirements and industry best practices to support drug development… more
- Merck & Co. (Rahway, NJ)
- …Line Engineering, Clinical Judgment, Communication, Flux Analysis, Human Health Risk Assessment , Innovative Thinking, Interpersonal Relationships, Mammalian Cell ... of clinical development, as well as process characterization and regulatory filings for successful commercialization.Improve upstream processes by increasing… more
- Merck & Co. (Rahway, NJ)
- …enterprise working groups, and cross-functional projects.Ensure all innovations meet regulatory compliance, risk management, and enterprise operational ... Cyber Defense organization.Key ResponsibilitiesTechnology & Vendor EvaluationLead the technical assessment of emerging cybersecurity tools, platforms, and vendors for… more
- Merck & Co. (Rahway, NJ)
- …for new product introductions and technology transfers across the network.Drive proactive risk management activities, including risk assessment , risk ... and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership and make… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …safety, managing our supply chain and sampling, supporting technological and data innovation, maintaining our facilities and assuring the integrity and completeness ... for leading company response from Deal to Contract (includes pre-deal assessment /analysis, development of business cases for Pricing Committee, offer development,… more
- Cipla (Central Islip, NY)
- …systems etc. Maintaining regulatory compliance in accordance with cGMP and Perform Data Integrity risk assessment of current Good Manufacturing Practices ... samples, finished products to ensure they meet quality standards and regulatory requirements. Understanding of regulatory compliance, quality management systems… more
- Merck & Co. (Durham, NC)
- …as formulation, filling, lyophilization, or automated inspection processesFamiliarity with process risk assessment tools, Quality by Design principles, and ... determine product dispositionPreparing and/or providing guidance and review for regulatory filings, process descriptions, investigations, and change requests. Acts… more
