- Merck & Co. (North Wales, PA)
- …and medical teams to ensure that promotional practices are consistent with regulatory guidelines, our company's policies, and support business objectives.Serve ... Job DescriptionReports to the Director/ Senior Director in the Office of Promotion and...policies and business objectives.Actively- participate in labeling and global regulatory team meetings to ensure support for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …cross-functional support to Legal Operations as needed Partner with Regulatory Analyst on the submission of all PMRP approved promotional material to ... cross functional assistance for PGC, Learning Management System (LMS) and Regulatory , as needed. ResponsibilitiesEditorial Review of Materials Review and consult… more
- Eisai, Inc (Nutley, NJ)
- …be primarily responsible for providing counsel specific to Eisai's pharmaceutical regulatory needs, including sales and marketing, scientific exchange and other ... pipeline and in-line assets. Essential Functions Provides proactive and day-to-day legal support , advice and counsel on a variety of commercial and medical matters… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good Clinical ... on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other vendor performance against… more
- Aequor (Thousand Oaks, CA)
- …This role will apply project management and operational excellence to support the execution of product launches, variation implementations, and other activities ... Facing SKU Change Records (CFSCR) Provide timely updates to stakeholders, eg, Regulatory , Supply Chain, Manufacturing, Quality on status of GDCR and/or CFSCR… more
- Insmed Incorporated (Bridgewater, NJ)
- …lists.OverviewAssist in the delivery of Clinical Operations objectives by providing operational support to the clinical study team (CST) with the responsibility to ... FDA regulations, project plans, ICH/GCP guidelines, government regulations, etc.Provides operational support for the Clinical Operations team with heavy focus on… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Durham, NC)
- …incidents, Quality Notifications (QNs), and other key automation-related processesProviding direct support for regulatory inspections and audits and other ... Job DescriptionPosition Description: Senior Specialist, Manufacturing Automation The Senior ...with cGMPs. The Manufacturing Automation Sr. Specialist must actively support , participate and embrace an empowered team culture including… more
- Merck & Co. (Durham, NC)
- Job DescriptionWe are seeking a Growth and Improvement minded- Senior Maintenance Technician - HVAC & Refrigeration that can help drive our Strategic Operating ... - They are a Competitive Advantage for UsSummary, Focus and Purpose The Senior Maintenance Technician - HVAC & Refrigeration is accountable for providing maintenance… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Technician, MaintenanceThe Senior Maintenance Technician is responsible for providing equipment troubleshooting and ... maintenance support for ongoing facility facility/manufacturing operation and ...Quality, Automation, Technology, and other groups as required.The Lab Senior Maintenance Technician will provide maintenance supporting vaccine process… more
- Eisai, Inc (Nutley, NJ)
- …to the Senior Director, Omnichannel Marketing (HCP and Patient). The associate director will also partner closely with key internal partners to deliver ... omnichannel and media specific marketing input and activities.The Associate Director of Omnichannel Marketing and Media is responsible for managing, executing and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …accounting, uphold workplace safety, manage our supply chain and sampling, support technology, provide commercial operations, insights & analytics, maintain our ... managing the day-to-day operations of the Rare Disease patient access and support programs. Additionally, this person will be responsible for driving new initiatives… more
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. Job Summary The Associate Director, Clinical Outsourcing, will oversee and lead and support activities related ... through supplier selection and final contract execution on projects when required. Support project teams in the resolution of performance issues if escalated… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical ... Operations team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic direction… more
- Merck & Co. (North Wales, PA)
- …Under the oversight of the System and Data Integration Lead (SDIL), the Associate SDIL is responsible for the integration between our source systems (primarily Data ... Supplier's environment.-Among key responsibilities are: TECHNICAL ENABLEMENT: Provides critical support in establishing technical and cross functional business needs… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …contracting agreements. In collaboration with the Associate Director, the Associate Manager will support CMR's partnership and alliance contract management ... entities. This position is an individual contributor. Essential Functions With support of Associate Director, manage complex contracting negotiations including,… more
- Novo Nordisk Inc. (Boulder, CO)
- …Inc. in December 2021. With a new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory ... and Clinical GMP Plants. Handle simple to moderate complexity validation projects. Support engineers in writing user requirements, SOPs, IQ, OQ, PQ, design… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …project needs and the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead on complex and/or late-stage project or act as main CMC ... and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential...to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case no Sr CMC… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. SUMMARYThe Associate Director, Pharmacoepidemiology position provides epidemiologic, methodological, and analytic ... support to Daiichi Sankyo products. This position contributes to...analysis of epidemiologic studies, including real-word evidence (RWE), supporting senior management in various epidemiological activities.This position independently carries… more
