- Repligen (Waltham, MA)
- … risk assessments, documentation, testing, remediation, and reporting.Collaborate with senior management and cross-functional teams (Finance, IT, Legal, ... -related activities are documented, tracked, and aligned with the company's overall risk management strategy.Evaluate and implement new tools, technologies, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Collaboration:Facilitate effective communication and collaboration with internal stakeholders, including IT and Compliance Risk Management as well as Global ... areas centered around rare diseases and immune disorders. SummaryThe Sr . Director, Data Quality and Integrity (Global R&D &...culture of compliance and accountability in data management practices. The position also involves risk -based… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and mitigate identified ethics and compliance risks as part of NNI's risk management program. This role leverages innovative technology, data analytics and ... Identify, evaluate, and implement technology and data analytics solutions that enhance compliance monitoring, reporting, and risk management Utilize data… more
- Merck & Co. (Rahway, NJ)
- …License:NoHazardous Material(s):n/aRequired Skills:Audits Compliance , Audits Compliance , Compliance Program Development, Currency Risk Management , ... International Trade Law, Investigative Skills, IS Audit, Legal Regulatory Compliance , Metrics Analysis, Process Improvements, Project Management , Project… more
- Merck & Co. (Rahway, NJ)
- …extensive experience in design controls, device transfer, control strategies, device risk management , and design verification testing to develop value-added ... Job DescriptionJob Summary: - Sr . Engineer, Device Technology is a key engineering...devices or combination products in both development and lifecycle management , ensuring compliance with relevant regulatory standards.Use… more
- Merck & Co. (Millsboro, DE)
- …environment in compliance with local, state, and federal regulations. The Sr . Specalist of Biosafety will collaborate with various departments to promote best ... Job DescriptionSr. Specialist, Biosafety The Sr . Specialist of Biosafety is accountable for providing...of federal, state, and local biosafety regulations, and advise management accordingly.Review risk assessments for biological materials… more
- Merck & Co. (Rahway, NJ)
- …Operations, Clinical Research, Clinical Study Design, Clinical Testing, Clinical Trial Compliance , Clinical Trial Management , Critical Thinking, Data Analysis, ... Development, Ethical Standards, Health Literacy, ICH GCP Guidelines, Informed Consent, Management Process, Manufacturing Compliance , Medical Writing, Motivation … more
- Merck & Co. (Rahway, NJ)
- …devices and combination products globally.- Experience in design controls, device risk management , medical device, complex combination product kits, prefilled ... picture, and how activities link to our Company strategy and business goals- Utilize device risk management tools to build device or combination product risk … more
- Merck & Co. (Rahway, NJ)
- …effectively communicate with stakeholders at various levels, including cross-functional teams, senior management , external vendors, and clinical sites. Strong ... Management , Cross-Functional Team Leadership, Data Analysis, Detail-Oriented, Financial Risk Management (FRM), Good Manufacturing Practices (GMP),… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …proactively represented at program level and support proactive quality risk management process.Interact with the audit and compliance function for the ... of MA risks identified through audits, inspections, internal meetings, remediation and risk management in close collaboration with the organization's quality … more
