- Eisai, Inc (Nutley, NJ)
- …security and data privacy standards. Your responsibilities span security operations, risk assessment , investigations, and compliance issue resolution for the ... compliance policies.Assess inherent and residual IT compliance risks using a risk assessment framework.Oversee documentation, implementation, and testing of IT… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …that audit targets for tactical and strategic GVP audits are in place. Review risk assessment documents stemming from audit outcome to increase compliance within ... internal QA stakeholders such as GMP QA, specifically for GDP requirements, risk -based assessment for Distributors, co-partners, and affiliates. Liaise with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the study is executed according to the agreed project plan. Complete a study risk assessment and ensure mitigation and contingency measures are prepared and ... DS/CRO Joint Operating Committee. Work with Process Excellence and Risk Management to ensure oversight plans are in place...Daiichi Sankyo's quality measures. Leads the creation of the Risk Identification and Management Log (RIM Log) and other… more
- Merck & Co. (Rahway, NJ)
- …through launch.- The successful candidate will be responsible for resourcing planning, risk assessment strategies, talent development, and partnering to build a ... policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including merit… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …based on the MOA and initial toxicological profile. Provide a first, preliminary benefit/ risk assessment and make available to senior leadership at DP0. Surface ... Assist teams in maintaining oversight of changes to the benefit/ risk balance. Provide expert input on surveillance, assessment...benefit/ risk balance. Provide expert input on surveillance, assessment and mitigation of changes to the risk… more
- Insmed Incorporated (Bridgewater, NJ)
- …follow-up and close-out of compliance issues and/or risks as identified by risk assessment and Monitoring and Auditing teamCollaborate with Compliance Operations ... approach to compliance that is focused on partnerships, prevention and risk mitigationRaise awareness of the Compliance program and foster accountability for… more
- Merck & Co. (Rahway, NJ)
- …products. -The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and ... policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including merit… more
- Merck & Co. (Rahway, NJ)
- …CMC sections of regulatory submissions and associated source technical reports and risk assessment documents. The ideal candidate should bring expertise in ... a wide variety of immunological and cell methods and technology for assessment of biological potency with an emphasis on subject matter expertise related to potency… more
- Aequor (Thousand Oaks, CA)
- …and commercial lifecycle maintenance, product stability programs, CMC regulatory filings, risk assessment , and Quality Management Systems. offers the opportunity ... owned regulatory filing sections and RTQs? Provide expertise in science and risk -based evaluation of complex process and product quality data, including ability to… more
- Merck & Co. (Rahway, NJ)
- …15 years of experience with engineering design, equipment operation, vendor interface, risk assessment , process safety and industry guidance.- Project Size is ... in its discretion that the nature of the role presents an increased risk of disease transmission.Current Employees apply HERE Current Contingent Workers apply HERE… more
- Merck & Co. (Rahway, NJ)
- …- Significant experience with engineering design, equipment operation, vendor interface, risk assessment , process safety and industry guidance are essential ... in its discretion that the nature of the role presents an increased risk of disease transmission.Current Employees apply HERE Current Contingent Workers apply HERE… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …CAPA implementation. Indirectly oversee Investigations Managers, providing guidance and support. Risk Assessment and Prioritization: Conduct risk assessments ... priority. CAPA Management: Oversee the timely implementation and effectiveness assessment of corrective and preventive actions identified during investigations.… more
- Merck & Co. (Rahway, NJ)
- …attaining desired results. Reviews and defends stage-gate deliverables for programs, including risk assessment and mitigation plans, and engages in corporate ... in its discretion that the nature of the role presents an increased risk of disease transmission.Current Employees apply HERE Current Contingent Workers apply HERE… more
- Merck & Co. (Rahway, NJ)
- …filings.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary.Maintaining an ... in its discretion that the nature of the role presents an increased risk of disease transmission.Current Employees apply HERE Current Contingent Workers apply HERE… more
- Catalent (St. Petersburg, FL)
- …Reports (non-GMP, Clinical, Registration, Process Validation, Product Transfer, etc.), Risk Assessment , Formulation Reports, Development Reports, Material ... Evaluation Requests, Material and API Specifications; Product specifications; Test methods; b) RTE, Process improvement projects and Product Development Projects; c) Stability Protocols and cleaning validation documents; d) Deviations, Laboratory… more
- Aequor (Devers, TX)
- …with Contractor Safety, Safe Work Permit Program Support EHS training and Risk /Hazard Assessment Initiative/autonomy EHS audits EHS program implementation Job ... and teams; and EHS self-assessments, inspections, GEMBAs, and audits. Perform risk and hazard assessments throughout the campus. This includes involvement in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …analysis/evaluation. May contribute to safety action recommendations, and communication and risk minimization plans. Presents assessment to the appropriate ... analysis/evaluation. May contribute to safety action recommendations, and communication and risk minimization plans. Presents assessment to the appropriate… more
- Catalent (St. Petersburg, FL)
- …and conduct Pre-Audit Preparation activities with an understanding of requesting sites risk assessment to ensure alignment to Global Standards Ensure generation ... of audit reports, management of supplier response and CAPA. Work collaboratively with the supplier to assess and conclude acceptance of supplier identified CAPA are completed in the required timelines Monitor and facilitate activities required to assure… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and preventive actions, as necessary. Supports internal/external audits. Supports Quality risk assessment teams. Review/approve documents as a Quality on ... the Floor Subject Matter Expert (SME). Remain current in skills and industry trends. Requirements Minimum of a Bachelor's Degree in Science, Information Science or equivalent technicaldiscipline is required. Minimum of 6 years relevant work experience is… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy. Advise system and project teams on information security procedures. Conduct risk identification and assessment with attention to the business processes ... risks are effectively assessed, understood, and managed in alignment with our risk management process. The individual in this position will: Seek understanding of… more
