- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Job Summary:This position will be a member of the Risk Management Center of Excellence office who will help manage risk ... leadership. Individual will provide strategic advice, teachings, and support related to risk management planning, risk management sciences, and risk… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in R&D as early as possible. This led us to create the Translational Patient Safety Senior Director position, which will have unique exposure to Daiichi Sankyo's ... to external expertise for novel safety issues requiring safety surveillance and/or risk mitigation.Responsibilities- Research and Nonclinical Development:… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and be responsible for overall product safety strategy or specific areas of safety surveillance and risk management , and provide safety leadership ... centered around rare diseases and immune disorders. Summary The Director , Clinical Safety , will be a product...topics, and regulatory submissions. This individual will ensure proactive safety monitoring and risk management … more
- Merck & Co. (Durham, NC)
- …Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain Capital project management experience Risk Management experience Experience ... products. We work in the manufacturing plants with a " Safety First, Quality Always" mindset striving for continuous improvement....substance manufacturing facility. As a direct report to the Director of Operations, the Associate Director will… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director , ESQL is responsible for all activities at the External Entity (EE) site associated with the manufacturing of company products ... all applicable regulatory requirements, regulatory filings and company policies.The Associate Director also ensures that effective and robust Quality systems are… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SummaryThis position supports safety monitoring and risk management activities, provides insights ... position works with other CSPV staff and cross functional Safety Management Team (SMT) members, often handling...- Risk Mitigation & Communication: Communicates any safety concerns to management and relevant team… more
- Tris Pharma (Monmouth Junction, NJ)
- … reports, periodic safety reports, signal detection activities and risk management planning. The incumbent works cross-functionally with counterparts/teams ... opening in our Monmouth Junction, NJ facility for a Director , Drug Safety . The Director ,...leadership responsibility Current leadership and oversight experience for global safety activities, operations and risk management… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study ... that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal and external stakeholders… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Technical Operations team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide ... Co-Lead Deviation Investigations: Collaborate closely with the Quality Associate Director to co-lead the deviation investigations management system.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as management of adverse events based upon approved Safety Management Team (SMT) materials- Supports overall program safety ... assessment of protocol deviations- Discusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …requires skills in working in a fast-paced environment, continuous improvement, project management , change and risk management . Responsibilities - ... opportunity employer including veterans and people with disabilities. Summary The Associate Director , External Data Management , is accountable for the end-to-end… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … safety studies, and contribute to the development and review of safety documents including Risk Management PlansEfficiency of Process, SOP: ... centered around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, and analytic support… more
- Eisai, Inc (Nutley, NJ)
- …teams; Supporting Safety processes, such as Case in-take, Case processing, Risk management and Safety reporting; Business Intelligence technologies such ... Master's degree or foreign equivalent in Computer Science, Information Technology Management , or Business Administration or closely related field plus 2 years… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with other Leadership Team members to optimize processes, resource allocation, and risk management strategies leveraging project management tool ... a specific focus on infrastructure, budget and non project initiatives. The Senior Director , Global Head of CR2 Project Management & Operational Excellence is… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are required and are equally ... is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This position may require… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: HVAC Operations Manager Reporting to the Associate Director in HVAC, the HVAC Operations Manager will be part of the 24-hour ... and embraces our team culture including significant interaction with operations, safety , automation, and other groups as necessary. This Position sits in… more
- Merck & Co. (Rahway, NJ)
- …and/or biologics process development.Experience in supporting compliance investigations and change management .Familiarity with US and EU GMP and Safety ... a fast-paced job that provides a high degree of technical and project management responsibility. The Specialist -Engineering position will report to the Associate … more
- Catalent (St. Petersburg, FL)
- …a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. The Quality Auditor will be ... Quality Auditor will be p erforming audits, generation of audit reports and management of supplier CAPA to ensure required actions are completed within the required… more
- Merck & Co. (Rahway, NJ)
- …job that provides a high degree of technical and project management responsibility.The Associate Specialist -Operations Support position will report to the ... Associate Director , Engineering and will be a member of the...is compliant with various site requirements (eg, environment and safety ) and other regulations as needed, and that the… more
- Merck & Co. (Rahway, NJ)
- …documents.Experience with Quality SystemsExperience in supporting compliance investigations and change management .Familiarity with US and EU GMP and Safety ... fast-paced job that provides a high degree of technical and project management responsibility. The Senior Specialist - Manufacturing Automation position will report… more
