- Legend Biotech USA, Inc. (Raritan, NJ)
- …Actions (CAPA) process, and is responsible for ensuring compliance within quality systems processes. Key Responsibilities Lead the CAPA program for the ... quality systems records. Implement and lead CAPA site governance program . Drive continuous improvement of quality systems processes. Implement processes… more
- Merck & Co. (Rahway, NJ)
- …and inclusion so everyone can bring their whole self to work.Within DSCS, the Digital Program Manager will advance the purpose and aspiration of our Company 's ... across organizational deliverables.- In this role, the DSCS Digital Program Manager will provide strategic and tactical...with our Company IT leadership to develop a long-term systems and capability strategy and to prioritize DSCS Digital… more
- Merck & Co. (Rahway, NJ)
- …individual is responsible to-manage/oversee a team of CTCs(Clinical Trial Coordinator).As line manager the role is critical to continuously develop future talent by ... interns-delegated to the Clinical Operations team based on the Internship program , while-properly managing situations of low or non-performance.The role will work… more
- Novo Nordisk Inc. (Boulder, CO)
- …alignment with global requirements Develops comprehensive, relevant resources (eg training program , FAQs) to enable compliance to change control process requirements ... change requests Develops and executes regular surveillance, follow-up, and reporting program to ensure process compliance Deviations: Acts in role of primary… more
- Merck & Co. (Rahway, NJ)
- …Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed. Performs Quality ... plan for assigned studies. Ensures compliance with CTMS, eTMF and other key systems in assigned studies. Escalates as needed different challenges and issues to TA… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … systems .Company Sponsored Studies (CSS) and Medical Access/Expanded Access Program (MAP)/(EAP)Support the oversight of the overall global oncology review process ... of GOMA clinical activities as appropriate.Responsibilities Clinical Operations Study/ Program ManagementCompany Sponsored Studies (CSS) Support the preparation, set-up,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... be preferable. Responsibilities Leadership, Direction, and Strategy:Leads implementation of Program /Therapeutic level external data collection requirements by partnering will… more
- Aequor (Thousand Oaks, CA)
- …skills: Strong excel, PowerPoint, and Smartsheet experience. Summary: The Project Manager Global Partnership Supply, under the supervision of the Manager ... MS Word, Visio, MS PowerPoint and MS Excel skills ; understanding of systems for sharing and collaboration ; excellent communication skills to work with cross-… more
- Aequor (Raleigh, NC)
- …MS PowerPoint and MS Excel skills; understanding of systems for sharing and collaboration; excellent communication skills to work with cross- program resources. ... Remote Position - Flexible Hours Manager is open to seeing candidates with a...innovative solutions to drive efficiencies. Collaborating with SP&O Sr Manager to support function wide initiatives including crafting and… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Learning & Development role will design and develop engaging, innovative, ... modalities to bring learning to life in the flow of work. The Manager , Learning & Development will collaborate with stakeholders across the organization, leveraging… more
- Eisai, Inc (NJ)
- …is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. ... Statistical programming, Clin Ops. etc. to ensure alignment on program objectives, facilitate document reviews, proactively resolve any issues etc.With… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …responsible for creating and assisting in the development of compliance program trainings and communications, including developing eLearning modules. This position ... they relate to Company-wide trainings and external/global trainings, as appropriate.Maintain systems and document training curricula to ensure that only current… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional activities related ... validation and migration activities relating to new or existing systems in Regulatory AffairsRequired Skills5 years of Regulatory Operations experienceExtensive… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …to develop, document, and implement new measurement methods and test systems .Demonstrated knowledge of programming languages in support of instrument automationGreat ... growing and dynamic environmentAbility to lead a team and manage a calibration program across facilities; off shift and weekends requiredAbility to lift up to 50… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …manufacturing processes and packaging equipment, unit operations, process control systems , computer systems , equipment cleaning, sterility assurance, process, ... plus Must understand the entire development process through engineering program and project management, conceptual design, detailed design, prototyping,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary:Oversee and lead the validation program for production equipment and processes used to support manufacturing of aseptic and terminally sterilized ... the validation team in the establishment and maintenance of validated systems . Coordinate technology transfer activities in support of commercialization. Serve as… more
- Eisai, Inc (Nutley, NJ)
- …at least 5 years of enterprise-level governance and management.Certified Information System Manager (CISM), Certified in Risk and Information Systems Control ... review adherence to standards.Oversee regional security vendors.Prioritize risk-based reduction efforts. Manager investigations.General Compliance Activities:Maintain an inventory of regulatory, commercial,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Corporate Compliance & Privacy Officer in setting the strategy and program requirements for the Corporate Compliance and Government Accountability Programs. The ... position is responsible for managing and operationalizing the program and team, related to the Ethics, Compliance & Privacy Department's Government Accountability … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a lower complexity or regional project or be partnered with a more senior project manager in support of a larger, more complex drug development project. As a project ... manager this position is accountable for partnering with the...the project environment to address gaps that impact the program /project.Manages the planning and use of program /project… more
- Novo Nordisk Inc. (Milwaukee, WI)
- …the medical management of Obesity. This may include practices, health systems , bariatric/weight management centers, employers with coverage, (and when relevant their ... chronically medically manage patients with Obesity. Responsible for ensuring the program goals are being properly executed within territory. Relationships Reports to… more
