- Novo Nordisk Inc. (Plainsboro, NJ)
- …and make the appropriate changes to ensure trial conduct is completed in compliance and meets Novo Nordisk's business standards Risk management: Assessing and ... ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and...needs are met through alignment of business plans and operational need within the Therapy Area and OED to… more
- Merck & Co. (Durham, NC)
- …new HPV vaccine drug substance manufacturing facility. As a direct report to the Director of Operations, the Associate Director will be accountable for the ... comprehensive technology transfer of the HPV vaccine manufacturing process while ensuring compliance with all regulatory and safety guidelines. Lead a diverse team… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionPosition Description: Associate Director - Site Digital Technology Lead The Site Digital Technology Lead is the representative for Global Animal ... appropriate support to site operations is maintained, and that all operational activities are compliant with regulatory, safety, cyber-security, business continuity… 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 ... that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal and external stakeholders… more
- Merck & Co. (Rahway, NJ)
- …Trust security strategy across the organization, with a particular focus on Operational Technology (OT), Identity and Access Management (IAM), and Cloud Native ... and design appropriate security controls.Conduct in-depth analysis of our Operational Technology environment, identifying potential vulnerabilities and recommending mitigation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …skills in continuous improvement, project management, change management and risk management.Responsibilities Project level AI/ML activities - Responsible, with ... direction and execute oversight of vendor delivery, to ensure compliance with the protocol, external/internal standards, applicable regulatory guidelines, policies,… more
- Merck & Co. (Rahway, NJ)
- …tracking TCO and other standard financial toolsAd-hoc initiatives to support operational financial management of the platform budget and forecastStrong partnership ... and alignment with EIT Finance and IT PMOEnsure compliance with IT financial controls and standardsQualifications, Skills & Experience: The ideal candidate will have… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The Senior Director , Global Head of CR2 Project Management & Operational Excellence is responsible for supporting the Global Head of CR2, the assigned ... Head of Centre for RWD / RWE (CR2) Project Management and Operational Excellence (PM-OE) will lead innovation, coordination, and strategic planning efforts and… more
- Merck & Co. (Rahway, NJ)
- …on automation within Biologics Process Research & Development (BPR&D).The Associate Director role-will provide process automation leadership within the BDC Pilot ... candidate will be able to immediately step in and provide operational support to controls and automation activities throughout the facility.-Primary… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …require proven skills in continuous improvement, project management, change management, and risk management. The position will act as main statistical contact for ... matter expert in meeting or teleconferences with Health Authorities. Ensure compliance with international regulations. Ensure inspections readiness as well as… more
- Insmed Incorporated (Bridgewater, NJ)
- …processes. This position will be accountable for all necessary strategic planning, risk management, operational execution and communication required for the ... Development Plan and associated functional plans. As a leader, the Sr. Director of Program Management will provide cross-functional operational and program… more
- Tris Pharma (Monmouth Junction, NJ)
- …success.We have an immediate opening in our Monmouth Junction, NJ facility for a Director , Drug Safety. The Director , Drug Safety is responsible for planning, ... safety reports, periodic safety reports, signal detection activities and risk management planning. The incumbent works cross-functionally with counterparts/teams in… more
- Merck & Co. (Rahway, NJ)
- …appropriate and consistent application of SOPs, standards and quality and compliance measures.Engage with cross functional stakeholders to identify areas for ... allocation and forecasting; and identify solutions to address resource and operational challenges.Contribute to building and fostering group capability for the… more
- Insmed Incorporated (Bridgewater, NJ)
- …in New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance , the Director , Quality Operations ... critical suppliers. Using influence, active engagement, and an understanding of compliance requirements, work with critical suppliers to ensure quality, consistent… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in continuous improvement, project management, change management, and risk management. ResponsibilitiesLeadership, Direction, and Strategy:Provides data management ... for Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This position may ... the Sr. CSM to take the role of both operational strategy and study execution. ResponsibilitiesStudy Management & Leadership...share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis and ensure… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThis role is accountable for execution and oversight of local operational clinical trial activities-in compliance with ICH/GCP and country ... standards internally and externally.Under the oversight of the CRD(Clinical Research Director ) / Director , Clinical Research, the individual is responsible… more
- Merck & Co. (Rahway, NJ)
- …either directly or through the hybrid team, including activities such as: Operational : software license compliance , software audit preparation, entitlement ... of our medicines, vaccines, and Animal Health products.Position Description: Associate Director , Software Asset Management (SAM)The Associate Director , Software… more
- Merck & Co. (Rahway, NJ)
- …Corporate Audit and Assurance Services' (MCAAS) provides value-added independent and risk based audit, assurance and advisory services.Position Overview Function and ... to the relevant requirements.Under the direction of the Client Audit Director ("CAD") and the Auditor-in-Charge ("AIC"), the Senior Specialist will:Participate in… more
- Merck & Co. (Rahway, NJ)
- …of engineering fundamentals. The MACS Operations Specialist position will report to the Director , Engineering and will be a member of the EF Team at the ... and innovation.They will collaborate closely with the development engineers & chemists, compliance representatives, and other team members to ensure the quality and… more
