- Merck & Co. (Rahway, NJ)
- …is responsible to support the operational functions of the Third Party Quality Management group, which provides quality oversight of suppliers and GMP service ... initiatives for profiled and platform vendor base,Operational execution for phase appropriate, risk based processes for third parties' performance oversight and… 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 ... and track the hiring timeline according to plan, identify risk or gap for timely escalation and develop contingency...and plan agendas weeks ahead of schedule.- PM/OE Team Management and Development, Vendor Oversight :- Lead and… 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 ... with business objectives.As the strategy evolves, prepare alternative development and risk management scenarios, project updates and options and recommendation… more
- Merck & Co. (Rahway, NJ)
- …activities as required. Analyzes headcount data to provide budget forecasts to management .Responsibility for oversight of an EE involving releasing of products ... permanent audit readiness, regulatory inspection support and monitoring, effective complaint management , change control oversight , metric review, and review of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …organizational performance objectives. The incumbent will be responsible for providing oversight and co-leadership of the investigation management system, ... Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic direction and leadership for the investigations … more
- Merck & Co. (Rahway, NJ)
- …and sterility assurance practices and guidelinesStrong experience with QRM (Quality Risk Management )Strong working knowledge of SDLC, GAMP and automation ... Quality Assurance, Facilities, Validation & Automation will provide Quality Assurance oversight and support to GMP facilities, equipment, and laboratories within our… more
- Merck & Co. (Rahway, NJ)
- …with minimal oversight from the line manager.-Ability to proactively develop risk management and mitigation plans in the country and-resolve issues locally. ... Job DescriptionThis role is accountable for execution and oversight of local operational clinical trial activities-in compliance with ICH/GCP and country… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …closely with the Global Clinical Lead to ensure alignment. CRO, 3rd Party Vendor Management and Oversight : Responsible for the oversight , performance, and ... written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are required and are equally… more
- Eisai, Inc (Nutley, NJ)
- …occurrences. This role will be required to provide input into vulnerability management , risk management , security architect, security operations center ... Demonstrated expertise in incident response, threat intelligence, security controls, and risk management .- Solid understanding of protocols (ie., SAML, SMB,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …agenda and minutes are in accordance with DS standards.CRO, 3rd Party Vendor Management and OversightResponsible for the oversight , performance and management ... quality and budget. A key focus will be the oversight of and interactions with CROs and other 3rd...and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are required and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and identified risks for select products during development. Assist teams in maintaining oversight of changes to the benefit/ risk balance. Provide expert input ... Sankyo's global drug portfolio from the Research stage to post marketing/lifecycle management . Our expectation is that the person filling this role will pioneer… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network Manages Phase 1 - Phase ... eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse events)- May participate in Site Initiation Visit… more
- Tris Pharma (Monmouth Junction, NJ)
- …leadership and oversight experience for global safety activities, operations and risk management strategies in pre and post marketing environments Expert ... aggregate safety reports, periodic safety reports, signal detection activities and risk management planning. The incumbent works cross-functionally with… 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 - ... management background and strong knowledge of 3rd party vendor management and oversight of external data standards. Knowledge of CDISC and SDTM and industry… more
- Merck & Co. (Rahway, NJ)
- …Line. This includes various Finance functions (Finance Planning & Analytics, Audit Management , Tax Management , Treasury Management , Account to Report, ... Automation across Enterprise Functions (Finance, HR, Business Development, Supplier Management among others). This role will collaborate closely with Business… more
- Merck & Co. (Rahway, NJ)
- …(including the CTC, CRAs and COM). Responsible for creating and executing a local risk management plan for assigned studies. Ensures compliance with CTMS, eTMF ... DescriptionThis role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Department, helping to ensure that the E&CDepartment takes a holistic view of risk management , considering broad organizational priorities as well as external ... Supports North America and serves on global projects. Provides guidance and oversight to team members as requested. Essential Functions Supports the Corporate… more
- Tris Pharma (Monmouth Junction, NJ)
- …implement improvements, including CAPAs and CPIs, across departments as appropriateApplies quality risk management principles in the design (and resolution) of ... New Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management Systems (QMS) supports,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …has strong skills in continuous improvement, project management , change management , and risk management . ResponsibilitiesLeadership, Direction, and ... (eg, study startup, study conduct, study closeout, and reporting).Provides oversight for Data Management CRO and other third party vendors to ensure compliance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …require strong skills in continuous improvement, project management , change management and risk management .Responsibilities Project level AI/ML ... authorities- Proactively identifies and manages risks in assigned projects Vendor Oversight - Under limited supervision, responsible for providing direction and… more
