- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trials and submissions work.Proactively identifies and manages risks for the data management function and supports functional risk identification/management ... compliance of outsourced activities.Ensures inspection readiness of all data management activities conducted internally or outsourced Management of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM ( Risk Based Quality Monitoring) sets the vision ... different disciplines and cultures. Must have technical knowledge on integrated data review and derivation/interpretation of metrics that can dynamically interface… 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 ... areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is accountable… more
- Merck & Co. (Rahway, NJ)
- …Project Plan for each MDCP Program (with target dates) for execution.Leads Quality/ Compliance Risk Assessments including Quality Risk Management Plans, ... capabilities that touch every aspect of our business processes, systems, and data .The Associate Director will collaborate and interact with cross-function teams… more
- Merck & Co. (Rahway, NJ)
- …Management, Business Operations, Business Transformation, Commercial Acumen, Communication, Data -Driven Decision Making, Developing Proposals, Enterprise Risk ... scope of this group includes strategic program management, enterprise strategic planning, risk management, as well as strategic venture investments in healthcare as… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director , Sustainability Strategy & Engagement will join the Company as a member of the Social Impact and Sustainability (SIS) function, ... sustainability, access to health, employee engagement, and ethics and values. The Associate Director will serve as a trusted advisor to business leaders , including… more
- Merck & Co. (Rahway, NJ)
- … data monitoring capabilities, and drive excellence in safety, compliance , supply, and productivity.Global Impact:Collaborate with colleagues across the US and ... documentation of all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process performance… more
- Merck & Co. (Rahway, NJ)
- …with US and WW regulations, company policies and standard operating procedures.The Senior Director of Clinical Supply Systems (CSS) is a key member of the GCS ... translating strategic priorities into integrated operational team activities.- The Senior Director of CSS will also ensure measurable and sustainable results through… more
- Merck & Co. (Rahway, NJ)
- …The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Human Health Digital Data and Analytics (HHDDA) team is innovating how we understand our patients and their needs. Working cross functionally we ... new ways of engaging,interacting with our customers and patients leveraging digital, data and analytics and measuring the impact. The Associate Director ,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Director , Launch Strategy and OperationsLocation: North Wales (Upper Gwynedd), PennsylvaniaDivision: Human Health US (HH-US)Therapeutic ... are passionate about driving impactful changes. Position Overview: As the Associate Director of Launch Strategy and Operations, you will lead the enterprise… more
- Merck & Co. (Rahway, NJ)
- …across the entirety of our non-sterile and sterile clinical portfolio. The Director is responsible for ensuring cGMP compliance and operational excellence ... Job DescriptionRaw Materials & Medical Device Director , Small Molecule Analytical Research & Development The Small Molecule Analytical Research and Development… more
- Merck & Co. (Rahway, NJ)
- …digital, data and analytics and measuring the impact. The Director , Global Commercial Pharma Pipeline Analytics, HHDDA will be responsible for developing ... Global Commercial Pharma Pipeline Analytics, Ophthalmology, HHDDAOur Human Health Digital Data and Analytics (HHDDA) team is innovating how we understand our… more
- Merck & Co. (Rahway, NJ)
- …excellence and compliance with our company's procedures for recording time, data entry, and trainings. The successful candidate will serve as a sounding board ... pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research… more
- Merck & Co. (Rahway, NJ)
- …(PAT), Product Development, Professional Networking, Quality Standards, Regulatory Compliance , Regulatory Submissions, Results-Oriented, Risk Assessments, Talent ... and manufacturing and ensure safety and quality of our products. -The Director , Biologics Analytical Research and Development (B-AR&D) is responsible for providing… more
- Merck & Co. (Rahway, NJ)
- …Compliance , Supply, Continuous Improvement, and Cost Management.--The Associate Director , External Manufacturing Operations will also assist in commercialization ... Lead Periodic Business and Operations Review Meetings (with External Partner).-- Compliance :-Achieve compliance goals through a risk -based approach… more
- Merck & Co. (Rahway, NJ)
- …audit and assurance services.Position Overview / Function and ResponsibilityThe Associate Director :Leads a small team through financial and compliance audits ... of the audits and assessments.Demonstrates knowledge of and techniques to assess risk and evaluate the effectiveness of internal controls in moderately complex… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director (Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed ... span all phases of clinical development (pre-clinical to post-licensure). The Director will manage the entire cycle of clinical development, including study… more
- Merck & Co. (Rahway, NJ)
- …Oversees trials within and/or across program(s)/therapeutic areas. -Ensures excellence in execution/ compliance to support study objectives and data validity. ... issues if they arise. - -Ensures appropriate clinical safety assessment and risk management of compounds. Conducts real-time oversight of ongoing trials to identify… more
- Merck & Co. (Rahway, NJ)
- …equipment and processes for medical devices/drug delivery systems. Reporting to the Director responsible for this area, you will partake in medical device assembly ... technical content of assembly process FMEAs to capture patient and process risk and identify appropriate in-process controls to ensure robust and efficient… more
