- Aequor (Thousand Oaks, CA)
- …Nice to have: Prior military planning experience background or prior pharma experience. Purpose: The Risk Management Senior Associate will serve as a ... impact analyses, continuity planning and exercises, and risk management initiatives. Key Activities: The Senior Associate will play an integral role in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …documents where necessary with supervision. This position conducts regulatory risk assessment and recommends developmental options with supervision, and this ... years direct or related CMC regulatory experienceSuccessful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and EMA… more
- Eisai, Inc (Nutley, NJ)
- …to report status of project schedule, timeline, budget and resource utilization to senior management on a regular basis. Leverage appropriate project ... this is your profile, we want to hear from you. Job Summary:The Associate Director, Global Alzheimer's Disease Project Management is responsible for facilitating… more
- Merck & Co. (Durham, NC)
- …goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management , Product Release, Change Control).- ... and ensuring excellence in Compliance, Supply, Continuous Improvement, and Cost Management .--The Associate Director, External Manufacturing Operations will also… more
- Merck & Co. (Rahway, NJ)
- …and DevSecOps practices in support of detection content lifecycle management .Preferred Certifications Microsoft Certified: Security Operations Analyst Associate ... Job DescriptionPosition Summary We are seeking a Cyber Defense Analytics Senior Specialist with specialized expertise in SIEM engineering and detection content… more
- Novo Nordisk Inc. (Durham, NC)
- …on shop floor Ability to support all processes & functions in Department Quality Risk Management Make decisions on quality & compliance issues with little ... study from an accredited university required May consider an Associate 's degree in life sciences or related field from...root-cause analysis tools & techniques a plus Experience with Risk Assessment & Risk Management … more
- Aequor (Thousand Oaks, CA)
- …Project Management experience OR Bachelor's degree and 8 years of Project Management experience OR Associate 's degree and 10 years of Project Management ... CMC experience. This role is focused on timeline and resource management . discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer… more
- Merck & Co. (Rahway, NJ)
- …effectively communicate with stakeholders at various levels, including cross-functional teams, senior management , external vendors, and clinical sites. Strong ... Project Management , Project Portfolio Management (PPM), Publications Management , Regulatory Compliance, Risk Management , Sourcing and Procurement,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …updates from the drug side, as needed. Provide RA specific inputs into CDx Risk Management plans for individual projects/indications. Assist the CDx team with ... of CTA/CDx within clinical trialsDevice protocols and SAPsDevice non-significant/significant risk determinations (both submission to CDRH in a Q-sub process… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …consistently and proactively represented at program level and support proactive quality risk management process.Interact with the audit and compliance function ... of MA risks identified through audits, inspections, internal meetings, remediation and risk management in close collaboration with the organization's quality … more
