- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Scientist, Device Risk Management Lead, is a crucial member of our team, responsible for spearheading risk management efforts ... commercialization, and lifecycle management . This individual will oversee device risk management activities to ensure the delivery of high-quality products… more
- Eisai, Inc (Nutley, NJ)
- …Drafting and Negotiation, Industry/ Regulatory Knowledge, Legal & Reputational Risk Management , Legal Knowledge, Mentoring/ People Development, Stakeholder ... solutions that enable the Company's innovation while protecting data and mitigating risk . The role requires deep expertise in privacy law, strong communication and… more
- Formation Bio (New York, NY)
- …faster and more efficiently.About the PositionFormation Bio is seeking an Associate Director, Program Management - Asset Diligence & Integration to partner with ... diligence efforts, support asset onboarding post-acquisition, and help build scalable program management infrastructure that enhances execution, visibility, and… more
- Bayer (Whippany, NJ)
- …licenses (eg, Core Data Sheet, Periodic Safety Update Report, clinical benefit- risk assessment for license renewals) for the compound(s);Lead the matrix- ... management of clinical trial teams, collaborating across the organization...to interpret, discuss, and present clinical trial or section program -level data;Proven experience with FDA regulatory requirements and ICH… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Responsible to complete on paper basis audit and to monitor vendor performance management program . Support the issue and communication of audit plans, agenda ... program to ensure adequate qualification of auditors per regulatory expectations. Risk Management and Vendor Performance: Responsible to ensure the … more
- Merck & Co. (Rahway, NJ)
- …Governance Management , Leadership, Oncology, Operational Excellence, Privacy Compliance, Quality Management , Risk Management and Mitigation, Risk ... for vendor selection, contracting input, performance oversight and portfolio management .Implements "Privacy and Compliance by design" frameworks from Enterprise… more
- Merck & Co. (Rahway, NJ)
- … - The complexity of categories and projects require high quality project and program management skills and a proven ability to manage change both internal ... managing the supply of direct and indirect materials, performing the supplier relationship management , supply risk assessment with actions in place and regular… more
- Formation Bio (New York, NY)
- …you will have the opportunity to establish the strategic development and operational management of Formation Bio's quality assurance program to support the ... including GMP, GCP, and ICH guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of quality risk... Management Systems (QMS). Extensive knowledge of quality risk assessment and management methodologies, with a… more
- Merck & Co. (Rahway, NJ)
- …manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical ... engineering design, engineering analysis and testing, medical device design controls, risk management , test method/fixture development, design verification and… more
