- Merck & Co. (Rahway, NJ)
- … management decisions and strategies.Utilize statistical methods to interpret risk data , providing clear and actionable recommendations rooted in empirical ... and apply regulatory and compliance requirements relevant to device risk management activities, ensuring adherence to industry standards.Lead risk… more
- Insmed Incorporated (NJ)
- …to Executive Management and Boards of Directors .Strong understanding of risk management , compliance , and audit processes within regulated industries, ... We are seeking an experienced leader to oversee cybersecurity operations, enterprise risk management , and Computer Systems Validation (CSV) program. This role… more
- Merck & Co. (Rahway, NJ)
- …with a team of scientists tasked with identifying, developing, and deploying data -rich technologies aimed at improving the manner in which process understanding is ... will leverage fundamental process modeling, machine learning, and other innovative data science approaches to enable our process research and development efforts… more
- Insmed Incorporated (NJ)
- …Risk Assessments, Company Core Data Sheet, Investigator's Brochure and Risk Management Plans (RMPs), and Risk -Evaluation and Mitigation Strategies ... the Senior Director will be responsible, globally, for implementing the safety and risk management activities for clinical development; be responsible for safety… more
- Eisai, Inc (Nutley, NJ)
- …Drafting and Negotiation, Industry/ Regulatory Knowledge, Legal & Reputational Risk Management , Legal Knowledge, Mentoring/ People Development, Stakeholder ... privacy solutions that enable the Company's innovation while protecting data and mitigating risk . The role requires... Management (Legal/ Compliance )Eisai Salary Transparency Language:The annual base salary range for… 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 ... thermal and distribution qualification for pharmaceutical products.Strong understanding of risk management principles.Strong strategic and analytical thinking,… more
- Merck & Co. (Rahway, NJ)
- …/ compliance requirements relative to design controls and risk management activities. Position Qualifications: Education Minimum Requirement: BA/BS ... and supporting continuous improvement initiatives related to design control and risk management processes for combination products. This includes identifying… more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutics, Business, Change Management , Combination Products, Compliance Packaging, Cross-Cultural Awareness, Data -Driven Decision Making, ... drug product, finished goods including combination products, and samples. Drive proactive risk management activities, including risk assessment, risk… more
- ValSource, Inc. (Rahway, NJ)
- …21 CFR Part 11 compliance and latest industry expectations for data integrity. Project Management experience in managing scope, cost, schedule, quality, ... projects simultaneously. Strong understanding of EPCMV, Quality by Design and risk -and science-based approaches for compliance are desired. Experience with… more
- Merck & Co. (Rahway, NJ)
- … Process, Managing Engineering Teams, Operational Metrics, Performance Monitoring, Project Management , Research Databases, Risk Management , Status Reporting, ... Instrument data , Spotfire, Thoughtspot, data lakes, dashboards, data models, etc.).Proficiency in portfolio management software such as Planisware,… more
- Merck & Co. (Rahway, NJ)
- …for new product introductions and technology transfers across the network.Drive proactive risk management activities, including risk assessment, risk ... Process, Manufacturing Scale-Up, Mentorship, Packaging Engineering, Process Optimization, Risk Management , Root Cause Analysis (RCA), Social Collaboration,… more
- Merck & Co. (Rahway, NJ)
- …compliance .Schedule Adherence: Understands schedule adherence impact and communicates risk .- Maintains a continuous improvement mindset and implements initiates ... partner groups including formulators, engineers, Quality, Safety, and Facilities management to drive overall success and performance of the...to increase efficiency or reduce risk to schedule adherence. Compliance :… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …will include contract owners and requesters, SME reviewers in Legal, Safety, Quality, Compliance , Data Privacy, IT, etc. Will interact with third-party vendors, ... for completeness, accuracy; identify necessary SME reviewers such as Quality, Safety, Compliance , IT based on business understanding and risk assessment;… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …activities in collaboration with the CRO, feasibility team and the study team.-Assist Data Management with development of the clinical database (edit checks, CCG ... file is complete and accurate for assigned stud(ies).-Ensure that a study level operational risk management plan is in-place and applies a smart- risk taking… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... rigorous feasibility, viability, and impact assessments to inform leadership decisions and de- risk scale-up. Novo Nordisk is currently in the process of adjusting… more
- Merck & Co. (Rahway, NJ)
- …Process Improvements, Clinical Supply Chain Management , Contract Management , Customer Alignment, Customer-Focused, Data Compilation, Detail-Oriented, ... , Key Performance Indicators (KPI), Materials Procurement, Medical Supply Management , Motivating Teams, Negotiation, Operational Excellence, Operational Risk … more
- Merck & Co. (Rahway, NJ)
- …, Quality Standards, Regulatory Compliance , Regulatory Requirements, Regulatory Submissions, Risk Based Monitoring, Risk Management , Strategic Planning ... GCTO footprint country Required Skills: Adaptability, Adaptability, Business Processes, Clinical Data Management , Clinical Research, Clinical Site Management… more
- Merck & Co. (Rahway, NJ)
- …equipment and infrastructure (eg Quality risk assessment, safety assessment, data integrity, change management , etc.)Provide next-level support to CSO when ... Company (eg our Company's Manufacturing Division) to build or risk -mitigate infrastructure Position Qualifications: Education Minimum Requirement: Bachelor's degree… more
- Merck & Co. (Rahway, NJ)
- …Communication, Data -Driven Decision Making, Influencing Skills, Leadership, Management Consulting, Oncology, Prioritization, Risk Management , ... strategy development, strategy execution and value realization, enterprise strategic planning, risk management , and strategic venture investments in healthcare… more
- Merck & Co. (Rahway, NJ)
- …and consensus facilitation and awareness of when to apply each.- Leverages scientific data to make disciplined risk -based decisions and shown to be capable ... Cross-Functional Teamwork, Decision Making, Drug Development, External Manufacturing, GMP Compliance , Innovation, Leadership, Life Science, Management Process,… more
