- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …has advanced skills in continuous improvement, project management , change management , and risk management . Responsibilities Leadership, Direction, and ... around rare diseases and immune disorders. Summary The Executive Director , Data Management (Head of Global Data...work.- Proactively identifies and manages risks for the data management function and supports functional risk identification/… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Strong financial acumen with experience managing budgets, forecasts, and headcount planning. Risk Management : Ability to identify, assess, and mitigate ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Manufacturing Execution System as part of the Global MSAT team based ... in Raritan, NJ. Role OverviewThe Director of Manufacturing Execution System (MES) will be part...manages an effective, holistic continuous improvement, problem solving and management program to improve process execution and system utilization… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the centralized teams (eg, Training and Documentation, Quality, Supplier and Contract Management and Digital Enablement). The Director Patient Safety Data ... workflow timelines and performance metrics to ensure departmental KPIs and regulatory compliance are met Lead deviation management activities, including root… more
- Merck & Co. (Rahway, NJ)
- …design, global filing and launch strategy, long-range demand vs capacity planning, integrated risk management , cost of goods projections, post approval change ... process and method technical changes, robustness/quality/ productivity projects. Manage product supply risk through Integrated Risk Management (IRM) and… more
- Merck & Co. (Rahway, NJ)
- …to support the EDSA review process. Manages programs (patient support, educational or risk management ) to support appropriate and safe utilization of Our Company ... Job Description Role Summary: The Global Senior Director Medical Affairs (GDMA) is a subject matter...skills (written and oral) in addition to results-oriented project management skillsPreferred: At least 3 years regional medical affairs… 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)
- …Electronic Common Technical Document (eCTD), Executive Business Management , Immunochemistry, Influence, Innovation, Interpersonal Relationships, Manufacturing ... Compliance , Mentoring Staff, People Management , Pharmaceutical Management , Professional Networking, Regulatory Communications, Regulatory Compliance … more
- Merck & Co. (Rahway, NJ)
- …Packaging Optimization, Packaging Processes, Pharmaceutical Development, Pharmaceutical Packaging, Risk Management , Technical LeadershipPreferred Skills: Current ... pulp/ paperboard and recyclables. - Required Skills: Combination Products, Compliance Packaging, Deviation Management , Engineering Standards, ISO Standard,… more
- Merck & Co. (Rahway, NJ)
- …and/or distribution and logistics of finished goods images, encompassing proactive risk management strategies, platform standards for standard finished goods ... blisters) meet safety, efficacy, quality, and robust supply standards. Drive proactive risk management activities, including risk assessment, risk… 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
- 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)
- …drug product, finished goods including combination products, and samples. Drive proactive risk management activities, including risk assessment, risk ... - DayValid Driving License:NoHazardous Material(s):N/ARequired Skills:Biopharmaceutics, Biopharmaceutics, Business, Change Management , Combination Products, Compliance Packaging, Cross-Cultural Awareness,… more
- Eisai, Inc (Nutley, NJ)
- … Risk Management , Mentoring/ People Development, Stakeholder Management (Legal/ Compliance )Eisai Salary Transparency Language:The base salary range ... profile, we want to hear from you. The Associate Director , Compliance Operations will be a key...trends, regulatory changes, and program enhancements C ontribute to compliance RAMP ( Risk Assessment and Mitigation Plan)… more
- Formation Bio (New York, NY)
- …CMOs, software vendors, and other biotech service providers. Knowledge of contract law, risk management , and compliance in vendor agreements. Ability to ... bring new treatments to patients faster and more efficiently.About the roleThe Director , Procurement will be responsible for establishing and managing a strategic… 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)
- …operationsNew Products including supply chain design, operations and/or planning - Risk Management and Business/Financial acumenGreen Belt or Black BeltRequired ... New Product Introduction (NPI), New Product Introduction Process, Operation Risk Management , Pharmaceutical Management , Pharmaceutical Manufacturing,… more
- Merck & Co. (Rahway, NJ)
- …and/or distribution and logistics of finished goods images, encompassing proactive risk management strategies, platform standards for standard finished goods ... exploring alternative ways to view and solve problems to achieve results. Drive proactive risk management activities, including risk assessment, risk … more
