- Insmed Incorporated (San Diego, CA)
- …Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Senior Manager has responsibility for the QA oversight of manufacturing build up ... Operations and CDMOs, associated vendors and contracted laboratories.Apply Quality Risk Management for key processes and systems. Identify improvement opportunities… 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 ... with members of Data Operations, DM, and Biostatistics, Clinical Study teams, IT/ Information Services and other stakeholders on developing and maintaining new SOPs,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Senior Project Manager , PMO as part of the Technical Operations team based in Raritan, ... 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)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Medical Coding is accountable for delivery of medical coding services for ... fast-paced environment, continuous improvement, project management, change management, and risk management.Responsibilities:Leadership, Direction, and Strategy:Responsible for medical coding deliverables… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …related to government reporting obligations, such as Aggregate Spend and Risk Evaluation and Mitigation Strategy (REMS) including the management and oversight ... E&C colleagues across Novo Nordisk globally, NNI Legal team, Information Technology, and other professionals throughout functionally related departments. External… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Manager as part of the Quality team based in Raritan, NJ. Role ... OverviewThe Quality Compliance Manager is responsible for regulatory compliance supporting the production...hoc, for activities such as annual product review, site risk register, or internal quality agreements.Develops and delivers training… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary The ITSM Process Manager for Change Management is responsible and accountable for managing and ... careful coordination with stakeholders and consistent quality assurance, minimize the risk of changes, strive for uninterrupted implementation, and ensure a stable… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …under the supervision of the IMT Lead.Management Review: Collect the data and information needed to ensure oversight of ongoing review of risks by evaluating Quality ... 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… more
- Merck & Co. (Rahway, NJ)
- …IT risk assessments, including identifying, evaluating, and analyzing risk mitigation.Education:Bachelor's degree in computer science, Information Systems, ... innovation. We are seeking an experienced and driven Product Manager for HRIT Compensation & Benefits to join our...information about personal rights under the US Equal Opportunity Employment laws, visit: - EEOC Know Your Rights… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to hire an Associate Director of Clinical Operations. This is a unique opportunity to work in a growing Clinical Operations Department that manages multiple early ... Implement and use efficient project management tools, eg, Communication Plan and Risk Based Quality Monitoring documents, such as Risk Assessment Categorization… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …minimal direction to complete tasks, knows how to get resources and information from established internal contacts; consults with Supervisor/ Manager for ... reports, interpret results, and generate technical conclusions consistent with quality risk management principles.Recognize patterns and trends in reported data and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of safety profile of assigned molecules/products and communicate safety information to internal and external stakeholders. Relationships This position will ... Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) according to implementation plans or as required by… more
- Merck & Co. (Durham, NC)
- …- For more information about personal rights under the US Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency ... harvest, lyophilization, product inspection, and quality control laboratories.The Quality Assurance Manager will direct Shop Floor Quality Assurance (SFQA) B160 to… more
- Merck & Co. (Durham, NC)
- …- For more information about personal rights under the US Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency ... preparation, and sterile supply. The candidate will have the opportunity to apply their enthusiasm and skills as a...objectives. Consults on an as-needed basis with next level manager on more complex decisions. Executes critical site review… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …approach, leveraging competencies, tools and technology. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships with ... trials, in line with established targets and strategies Implements proactive risk identification and mitigation planning for assigned clinical trial sites,… more
- Merck & Co. (Rahway, NJ)
- …- For more information about personal rights under the US Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency ... regulatory inspections. Independently performs audits of batch documentation, data, information , procedures, equipment and systems, and/or facilities to ensure the… more
- Merck & Co. (Rahway, NJ)
- …- For more information about personal rights under the US Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency ... successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development...of Company policy. The Executive Director will be a manager of managers, with keen focus on coaching and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …role 5 days per week Monday-Friday. Relationships Reports to: Sr. Manager Facilities, Engineering, and Metrology Essential Functions Engineering Data can include ... and maintaining applicable procedures Core roles include communication, compliance, risk management, and use of current technology The role...engineering data as well as the need to deliver information for use by decision makers and stake holders.… more
- Merck & Co. (Durham, NC)
- …- For more information about personal rights under the US Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency ... technical and operational problems through collaboration with peers.Applies appropriate risk management while adhering to cGMP requirements.Makes decisions guided by… more
- Merck & Co. (Durham, NC)
- …- For more information about personal rights under the US Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency ... performance objectives. Consults on an as-needed basis with next level manager on more complex decisions. Position Qualifications: Education Minimum Requirement:… more
