- Daiichi Sankyo, Inc. (Bernards, NJ)
- …signal, epidemiological data, and regulatory requirement synthesize into a coherent risk management strategy.Represents the CSPV department as subject matter ... cover signal activity across all DS regions. The Associate Director of the Signal Management Center of...content of any documents sent to regulatory authorities. Provides compliance metrics to management , as needed.Lead continuous… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …access programs.Partner with Medical Affairs to facilitate the implementation of a risk -based quality management process fully embedded through trial design, ... and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of...to conduct quality reviews of product profiles, ensuring thorough management review of all quality and compliance … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …External Quality and other internal functions to understand and mitigate any compliance risk and establish vendor quality scorecard.Support development and ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Head of Compliance as part of the Global Quality team based in Raritan, NJ. Role… more
- Merck & Co. (Rahway, NJ)
- …manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical ... engineering design, engineering analysis and testing, medical device design controls, risk management , test method/fixture development, design verification and… more
- Merck & Co. (Rahway, NJ)
- …easements and rights-of-way) Development and construction (design-build, EPC, CM-at- risk , construction management , architect/engineer, and ancillary agreements) ... real estate transactions and other agreements. Responsibilities: Work closely with management in Global Real Estate Services, Facilities, and regional business units… more
- Merck & Co. (Rahway, NJ)
- …point for the docketing team, attorneys, and staffImmediately reports all risk management -related concerns to Senior LeadershipResponsible for the compilation ... Job DescriptionPosition Description:The Office of General Counsel is seeking an Associate Director , IP Docket Management to provide docketing and legal… more
- Merck & Co. (Rahway, NJ)
- …, Quality Management Systems (QMS), Quality Strategy, Regulatory Compliance , Risk Management , Stakeholder ManagementPreferred Skills: Current ... Job DescriptionWe're looking for a Director of Quality Assurance to lead quality across...you'll be a core member of the Value Chain Management Team, guiding strategy, ensuring compliance , and… more
- Merck & Co. (Rahway, NJ)
- …and be decisive in an ambiguous environment.Experience and ability to achieve compliance goals through a risk -based approach with a deep understanding ... Job DescriptionDirector - Global Quality Auditing and Supplier ManagementThe Director will report to the Animal Health Global Quality...report to the Animal Health Global Quality Lead for Compliance and Technical Support and will direct the below… more
- Eisai, Inc (Nutley, NJ)
- …is your profile, we want to hear from you. The Manager of Treasury and Risk Management monitors and updates various cash flows and procedures, including domestic ... favorable debt and investment instruments. The Manager of Treasury and Risk Management assumes responsibility for corporate cashiering, accounts-receivable… more
- Merck & Co. (Rahway, NJ)
- …exploring alternative ways to view and solve problems to achieve results Drive proactive risk management activities, including risk assessment, risk ... thermal and distribution qualification for pharmaceutical products.Strong understanding of risk management principles.Strong strategic and analytical thinking,… more
- Formation Bio (New York, NY)
- …more efficiently.About the PositionFormation Bio is seeking a motivated, experienced Director , Formulation Development to join our dynamic team. This critical role ... supply chain, etc) quality assurance, regulatory, clinical pharmacology and project management to support short and long term program objectives. CRO and… more
- Merck & Co. (Rahway, NJ)
- …drug product, finished goods including combination products, and samples. Drive proactive risk management activities, including risk assessment, risk ... and external stakeholders. Required Skills: Biopharmaceutics, Biopharmaceutics, Business, Change Management , Combination Products, Compliance Packaging, Cross-Cultural Awareness,… more
- Merck & Co. (Rahway, NJ)
- …for new product introductions and technology transfers across the network.Drive proactive risk management activities, including risk assessment, risk ... Process, Manufacturing Scale-Up, Mentorship, Packaging Engineering, Process Optimization, Risk Management , Root Cause Analysis (RCA), Social Collaboration,… more
- Merck & Co. (Rahway, NJ)
- …extensive experience in design controls, device transfer, control strategies device risk management , and design verification testing to developvalue-added ... compliance .Essential Duties and Responsibilities:Program Leadership and Technical Project Management :Provide program leadership in the development, commercialization, and transfer… more
- Merck & Co. (Rahway, NJ)
- …product development, such as manufacturing process development and validation, design control, risk management , material and molding, design validation to create ... with design verification, including but not limited to, design controls, risk management , materials & molding, process development and validation,… more
- Merck & Co. (Rahway, NJ)
- …Description: Our Research and Development Division's microbiology team is seeking a Director for the Rahway NJ GMP microbiology operations.- The primary objective of ... oversee GMP environmental monitoring and microbiological release of pipeline products.- The director will provide guidance, lead activities, and strengthen a team of… more
- Merck & Co. (Rahway, NJ)
- …Intelligence (BI) Desktop, Natural Language Processing (NLP), Python (Programming Language), Risk Management , R Programming, Science, Scientific Literacy, Trade ... Job DescriptionInformation Sciences is seeking an Associate Director , Data Analyst to support the R&D efforts...to support the R&D efforts related to the Insider Risk /Trade Secret (IR/TS) program through advanced data analysis and… more
- Formation Bio (New York, NY)
- …with ICH-GCP, FDA regulations, and other applicable regulatory standards. Champion proactive risk management by identifying and mitigating risks before they ... to bring new treatments to patients faster and more efficiently.About the PositionThe Director of Clinical Project Management will provide overall leadership and… more
- Merck & Co. (Rahway, NJ)
- …strategy development, strategy execution and value realization, enterprise strategic planning, risk management , and strategic venture investments in healthcare ... Consulting, Collaborating, Communication, Data-Driven Decision Making, Influencing Skills, Leadership, Management Consulting, Oncology, Prioritization, Risk Management… more
- Merck & Co. (Rahway, NJ)
- …timely and accurate information and status updates to project sponsors and management .Champion compliance and safety; promote a culture of diversity, inclusion, ... regulatory submissions.-Under the general scientific and administrative direction of the Director in Biologics Cell Culture Sciences group and working in conjunction… more
