- Terumo Medical Corporation (Somerset, NJ)
- …study lifecycle. **Job Details/Responsibilities** Leading the development and execution of Clinical Risk Management Plans and Clinical Quality Plans for studies ... 13485 / 14971, 21 CFR 50/56/812, ICH-GCP, and FDA regulations - Strong auditing and risk management skills. Prior experience with auditing and risk … more
- Terumo Medical Corporation (Somerset, NJ)
- …Counsel and Chief Privacy Officer is responsible for managing the privacy, data management , and security program at Terumo Americas Holding, Inc. and certain ... training, and reviewing contracts from a privacy perspective. Provides Terumo management and various business functions with effective Legal support and advice… more
- Terumo Medical Corporation (Somerset, NJ)
- …(eg GxP, JSOX, etc). This role will conduct regular security audits and risk assessments such as Segregation of Duties and Critical Access risks to ensure ... to the company's procedure (ITSM, CHARM, etc.) for user management and role management . + Meet the...with appropriate parties to address issues and resolve the risk . + Perform security audits, monitoring system logs, and… more
- Terumo Medical Corporation (Somerset, NJ)
- …overall business and marketing objectives. 4. Stakeholder Engagement and Relationship Management : Manage and strengthen relationships with key opinion leaders and ... convert connections into strategic business opportunities. 5. Leadership & People Management : Build, develop, and retain a high-performing leadership team by setting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. We are currently seeking an IT Risk & Security Governance Intern for a year (June 2026 - May 2027). This ... hours per week. Responsibilities: This internship will support multiple projects in IT Risk & Security Governance. Partnering with team members, the intern will gain… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to realize your potential? The Position The Director of Alternative Models Program Management is responsible for ensuring the timely execution of ... By driving the collaboration among teams and key stakeholders, the Director of Program Management oversees the coordination and execution necessary to design,… more
- Formation Bio (New York, NY)
- …with ICH-GCP, FDA regulations, and other applicable regulatory standards. Champion proactive risk management by identifying and mitigating risks before they ... and clinical studies. Collaborate with cross-functional teams (Clinical Development, Regulatory, Program Management , etc.) to shape and refine Clinical… more
- Merck & Co. (Rahway, NJ)
- …Leadership, Networking and Partnerships, Program Management , Quality Management Systems (QMS), Quality Strategy, Regulatory Compliance, Risk ... across the full value chain for a late-stage ophthalmic program . In this role, you'll be a core member...you'll be a core member of the Value Chain Management Team, guiding strategy, ensuring compliance, and enabling manufacturing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and external vendors/contractors Ensure seamless operations and timely delivery of safety data Risk Management Act as the primary point of escalation for ... end-to-end processes and resourcing for case processing. This role leads the Case Management Activities and oversight of case Intake, Triage and case processing. The… more
- Merck & Co. (Rahway, NJ)
- …and will direct the below aspects of the Supplier Quality Management (SQM) and Animal Health global auditing program :ResponsibilitiesPerform comprehensive ... Quality Agreements.Design and build Business Continuity Process and Quality Risk Assessment Module in Reliance.Implement standard Supplier Qualification process… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …problems, providing guidance to leadership including trade-off and implications assessment (value, risk , cost, time) to the project or program .Prepares and ... program plans. Having experience with global teams, budgetary management , resource planning, and fiscal awareness is preferred.Provide technical expertise of… more
- Avet Pharmaceuticals Inc (East Brunswick, NJ)
- …Avet Pharma. This position will focus on the recognition, evaluation, and control of EHS risk at the facilities and the overall compliance of the site to EPA, OSHA, ... and industrial processes Managing site safety & security procedures to include management of the badge system for employees, temps, contractors, and visitors Other… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …projects.Support the enhancement and Global harmonization of the supplier qualification program , including management of the electronic systems for this ... Management Review (QMR).Support management of the Quality Management Review (QMR) program .Support continuous improvement efforts through the monitoring… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams.Ensure consistent and proactive representation of Quality at all stages of the program management process.May Interact with management at all levels ... access programs.Partner with Medical Affairs to facilitate the implementation of a risk -based quality management process fully embedded through trial design,… more
- Merck & Co. (Rahway, NJ)
- …product development, such as manufacturing process development and validation, design control, risk management , material and molding, design validation to create ... with design verification, including but not limited to, design controls, risk management , materials & molding, process development and validation,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Manager, Employee Relations, is pivotal in ensuring consistent and thorough management of Employee Relations processes (including corrective action) across the ... business areas of support. They are responsible for consulting with management on best practices for coaching, performance and behavioral concerns while ensuring… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …systems and processes of the Daiichi Sankyo's GxP group.Together with regional management teams plans, will support, conducts and reports internal systems and ... for the area of GxP audits assigned.Responsibilities:Execute the audit program for internal systems as applicable for the area...in alignment with the Master Audit Schedule using a risk -based approach to ensure the Audit Plans are aligned… more
- Merck & Co. (Rahway, NJ)
- …extensive experience in design controls, device transfer, control strategies device risk management , and design verification testing to developvalue-added ... Development and Technology Organization. Thisposition is responsible for providing strategic program leadership, technical expertise, and project management in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Real Estate; Digital, Data and IT; Finance and Tax) and complex and high- risk supplier contracting. Relationships This job reports to the Managing Assistant General ... contracting and recommend best practices and solutions Proactively conduct comprehensive risk assessments to identify potential legal and operational risks within… more
- Merck & Co. (Rahway, NJ)
- …strategy development, strategy execution and value realization, enterprise strategic planning, risk management , and strategic venture investments in healthcare ... Consulting, Collaborating, Communication, Data-Driven Decision Making, Influencing Skills, Leadership, Management Consulting, Oncology, Prioritization, Risk Management… more
