- 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)
- …with management experience At least 5 years of experience as a Clinical Trial Manager Experience with global clinical trial operations , in multiple phases of ... are looking to hire an Associate Director of Clinical Operations . This is a unique opportunity to work in...use efficient project management tools, eg, Communication Plan and Risk Based Quality Monitoring documents, such as Risk… more
- Merck & Co. (Durham, NC)
- Job DescriptionM 1 Operations Manager - - Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with ... Durham employs 1,000+ people. - This role as a Manager , Operations will be an energetic, leader...lead others - Ability to be flexible and understand risk - Continuous improvement - Conflict resolution- - Leadership… more
- 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 ... and operations at Insmed's gene therapy (GTx) manufacturing facility acting... and CDMOs, associated vendors and contracted laboratories.Apply Quality Risk Management for key processes and systems. Identify improvement… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …organization to guide enterprise-wide resource allocations, investment choices, drive core operations and develop insights to drive growth and operational excellence ... handling state tax audits and notices, evaluating state tax risk , and ensuring realization of state credits and incentives...of state credits and incentives for all Novo Nordisk operations in the US. This role will serve as… 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 ... (CPIs), Product Quality Complaints (PQC) documentation, compliance efforts, quality operations , etc. Responsibilities:Assures compliance with all SOPs, cGMP, FDA, as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …project team level and relevant governance bodies.Triage, resolve or escalate study issues / risk mitigations to the Operations Program Lead and study team ... International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key internal and external… 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
- 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 ... Data Management Data Operations team and serves both as a subject matter...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)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Senior Project Manager , PMO as part of the Technical Operations team based in ... of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. The individual will be responsible for… 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)
- …trends and best practices. Relationships Reports to the Director, E&C Strategy & Operations . Works closely with the E&C Leadership team, E&C Privacy team, NNI Legal ... and execution of special projects Supports Director, E&C Strategy & Operations with E&C Program governance and associated special projects Identifies, analyzes,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Financial Disbursements, that manages the day-to-day Financial Disbursement operations (Accounts Payable Processing, Travel and Expense Reimbursement and ... and accuracy of payments. Specifically, this role will be accountable for operations , suggest and collaborate with Financial Disbursement team members and global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …applicable Global QA processes and quality standards for continuous improvement and operations excellence. This may include the review of business partner SOPs and ... on applicable RD processes and quality standards for continuous improvement and operations excellence. Closely cooperate with the Global Audits and Compliance, PV/MA… more
- Merck & Co. (Durham, NC)
- …harvest, lyophilization, product inspection, and quality control laboratories.The Quality Assurance Manager will direct Shop Floor Quality Assurance (SFQA) B160 to ... response.Will support and prepare Set-up Activities for SFQA First Shift (Days).Support Operations and the Technical Operations Deviation Management groups with… more
- Merck & Co. (Rahway, NJ)
- …productivity and foster innovation. We are seeking an experienced and driven Product Manager for HRIT Compensation & Benefits to join our dynamic team.Our company is ... ADP, Middleware, and other technologies. The Compensation and Benefits Product Manager will lead cross-functional teams in selecting innovative technical solutions… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations , Regulatory Affairs, Data Management, Biostatistics, Non-clinical, Medical Affairs, ... 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)
- …skills as a member of a multidisciplinary team supporting the operations of pharmaceutical, biologic, and/or vaccine manufacturing facilities. The successful ... objectives. Consults on an as-needed basis with next level manager on more complex decisions. Executes critical site review...validation documentation as needed. May act as a Quality Risk Assessment Lead. - - Education Minimum Requirement: High… 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 ... projects for NACD & Novo Nordisk (eg, across NACD, CMR, International Operations (IO), and HQ R&D). Provides excellent customer service and builds strong… more
- Merck & Co. (Durham, NC)
- …and approve BOM changes and Master Batch Records.Review and approve Operations , Technology, or Automation protocols.Leads or actively participates in project suite ... technical and operational problems through collaboration with peers.Applies appropriate risk management while adhering to cGMP requirements.Makes decisions guided by… more
