- Daiichi Sankyo, Inc. (Bernards, NJ)
- …may be shared with the relevant business functions teams within the DS organization. Risk -based Quality Oversight. Contribute to the measurement of DS KPIs / KQIs to ... allow for adequate interpretation of risks and trends. Provide interpretation, with oversight by RD Quality team members, of GCP regulations and company process standards, guidelines, policies, and procedures, in close collaboration with RD Quality team… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Program Manager , Cleaning Validation as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Program Manager , ... integrate cross-functional requirements and balance competing priorities effectively.Cleaning agent risk assessment and cleaning efficacy studiesStrong understanding of regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to identify QA risks at CMO's and support the recommended courses of risk treatment and resolution manner in appropriate way and to ensure continuous improvement ... and approval of documents associated with validation or qualification activities, risk assessment strategies, technical studies and applicable changes that may… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking Senior Project Manager , PMO as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be responsible ... plans across functional teamsDefines the interdependent deliverables and ensures that quality, risk , cost, time are managed within the overall approved plan to drive… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key internal and external ... abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery role, reporting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Clinical Data Repository Administration is a member of the Biostatistics and ... study. Establish appropriate work procedures/guidance, logs, templates, quality procedures, risk impact assessment mitigation procedures, to maintain audit readiness,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …reports, interpret results, and generate technical conclusions consistent with quality risk management principles.Recognize patterns and trends in reported data and ... resources and information from established internal contacts; consults with Supervisor/ Manager for decisions outside establishedprocesses.Provide guidance to other employees… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Division of the Company. [Specific assignments to be determined by direct manager of the role.Creates, implements, and presents training programs and materials on ... include creating corporate-level policies, guidance documents (ie standing legal risk analyses), and training of Company employees.Monitors current developments in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the US and globally as assigned. [Specific assignment to be determined by direct manager of the role. Global Human Resources (including Benefits) Acts as the legal ... may include creating corporate-level policies, guidance documents (ie standing legal risk analyses), and training of Company employees, as well as implementation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …functional team members.Maintains global integrated project plans, project timelines, risk management plans and communication plans. Resolves complex problems and ... in a biotech or pharmaceutical company.Demonstrated success as a project manager /leader in planning and executing strategies for global drug development,… more
- Genmab (Plainsboro, NJ)
- …to fulfilling our purpose.The Role.The Director, Privacy Technologist & Third-Party Privacy Risk reporting into the Head of Global Data Privacy Program, will serve ... policies; and (ii) the implementation and oversight of Genmab's third-party privacy risk compliance function. Successful candidates will have a deep understanding of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …A WEEK, IN OFFICE IS REQUIRED The Position The purpose of the Content Project Manager role is to oversee and manage the execution of content projects from strategy ... leveraging project management tools such as Workfront, the Content Project Manager monitors task progress, mitigates risks, and maintains efficient workflows. This… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a proactive approach to ethics and compliance, focusing on partnership, risk mitigation, prevention, and the advancement of business development areas, including ... processes surrounding emerging therapeutic areas Supports E&C teams with special projects, as needed Physical Requirements 10-20% overnight travel required. Qualifications A Bachelor 's degree from an accredited institution required, additional… more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems ... improvements, including CAPAs and CPIs, across departments as appropriateApplies quality risk management principles in the design (and resolution) of key quality… more
- Merck & Co. (Rahway, NJ)
- …the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans for all activities ... products and non-our company marketed products . - Analyzes and anticipates project risk s as they relate to clinical supply chain deliverables and prepares ,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …policies and procedures. The role may have an external or internal project manager as a dotted line. Essential Functions Strategic Launch Planning: Develop and ... and brand activities. Secure global funding and assess progress during pre-launch Risk Management: Proactively raises risks within the brand/launch plan to brand and… more
- Merck & Co. (Rahway, NJ)
- …arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of contact ... needed Demonstrates high capability to solve unstructured problems, make informed risk decisions considering both technical & business risks, & influence portfolio… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …disease states based on current regulatory environment and competitive landscape Assess risk and advise on mitigation strategies to meet overall business need, while ... or US labels regarding feasibility of promoting potential data/claims with manager oversight Participate/assist in US labeling negotiations as necessary. Ensure that… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …management system such as Azure DevOps. Relationships Reports directly to the manager of Global Security Operations - Security Analytics and Automation. Will support ... to, identifying and addressing stakeholder needs Understands and applies risk management practices: Supports the implementation of security policies, procedures,… more
- Bank of America (New York, NY)
- EFR Liquidity Risk Manager Charlotte, North Carolina;Jersey City, New Jersey; New York, New York; Chicago, Illinois **Job Description:** Job Description At Bank ... and results, and connects to team strategy, priorities and contributions. + Risk Manager : Ensures proper risk discipline, controls and culture are in… more
