- Novo Nordisk Inc. (Plainsboro, NJ)
- …packages for FDA meetings (pre-IND, EOP 2, pre-NDA, pre-BLA) for review by Project Leaders Write Regulatory documents translating team strategy into ... overview documents such as cover letters, pre-meeting package, and other US specific regulatory positioning documents to assist Project Leaders in support of… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …budget, schedule, and performance metrics for all projects under guidance of tenured project manager Lead small cross functional teams focused on improving ... for executing small to medium scale ($ 5MM) from scope development and project planning through project closeout. Accountable for engaging project … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma.Legend Biotech is seeking a Commissioning and Qualification Project Manager as part of the Technical Operations team based in ... and existing qualified systems within cell therapy manufacturing. The Commissioning and Qualification Project Manager will develop and manage all aspects of the… more
- Merck & Co. (North Wales, PA)
- …Administrative Professionals. Position Description/Summary: The GPAM Associate Director, Value & Implementation Project Manager (VIPM), is a core member of Value ... Project Management System, Project Management Training, Project Planning, Publications Management, Regulatory Compliance, Risk Management, Sourcing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... and serves as ad hoc member to the Global Project Team for late stage projects. This position manages...Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU… more
- Merck & Co. (Rahway, NJ)
- …wallets.Proven track record in vendor management, strategic planning, and regulatory compliance.Strong analytical, negotiation, and project management ... Job DescriptionPosition Summary:The Payments Manager will help lead the strategic direction, operational quality, and innovation of the credit union's payments… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The Senior Manager Health Care Professional Marketing will be responsible for supporting the development and ... and finance teams to ensure alignment with business objectives and regulatory requirements. Essential Functions Brand/Therapy Area Management o Support the… more
- Genmab (NJ)
- …and industry data standards (eg, CDISC/CDASH).Excellent cross-functional communication and project management skills.Experience supporting regulatory filings and ... protocol deviations and is a key driver for inspection readiness, regulatory compliance, and successful data submissions.The Associate Director will lead… more
- Merck & Co. (Durham, NC)
- …Process Development, Technical Services, Utilities, and Validation.We are seeking a Maintenance Manager in Durham, North Carolina to manage a team of Maintenance and ... Engineering personnel. The Manager will provide direction and technical guidance to maintenance...and technical guidance to maintenance technicians for a capital project startup. In this role you will actively manage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(ISS) for oncology submission compounds, and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) annotation ... and ensure its quality and integrity- Oversee statistical programming vendor on project planning and execution to ensure high quality deliverables and timelines met.… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The Programming Manager supports the development of new therapies by ensuring integrity, consistency and adherence ... programming efforts of at least one study are in scope.The Programming Manager will support the Data Management, Statistics, Drug Safety, Medical, Clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to experiment with us? The Position The Senior Manager , Patient Support Data Intelligence is responsible for process improvement, technology, ... other documentation to assist with audits and inspections, both internal and by regulatory authorities Design, develop and manage tools which are being used to… 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
- Novo Nordisk Inc. (West Lebanon, IN)
- …processes Ensure that all activities comply with company and or regulatory procedures, practices and guidelines Follow all safety & environmental requirements ... manufacturing quality system, including knowledge of FDA requirements preferred Strong project management capabilities to guide the creation of high-quality SOPs… more
- BioAgilytix (San Diego, CA)
- …in our San Diego lab, ensuring full compliance with all laboratory SOPs and regulatory requirements. We're seeking an experienced manager to lead these teams, ... up to 40 employees. This role is accountable for daily operations, regulatory compliance, and scientific quality, while mentoring departmental leaders to promote… more
- Merck & Co. (Durham, NC)
- …procedures, engineering design guidelines and business plan; receives guidance from manager when necessary.Provides & Implements technical guidance to given tasks, ... for plant engineeringEnsures utility operations daily priorities and schedules project /work meeting the criteria established by site objectives.Support & lead… more
- Merck & Co. (Durham, NC)
- …according to high standards of quality and in compliance with all regulatory requirements. -The Senior Specialist, Quality Assurance will support ongoing efforts to ... meet performance objectives.Escalating and consulting with the next level manager on more complex decisions as needed.Position QualificationsEducation Minimum… more
- Merck & Co. (Durham, NC)
- …escalate risks and cascade information. -Align a cross-functional team around the project mission/work plan. -Interface and align with key Service Providers of ... above, but future roles and responsibilities are dependent upon future project workload and locations.Primary activities include, but are not limited to:Guide… more
- BioAgilytix (Durham, NC)
- …(LC/MS) team is seeking a Scientist III to serve as Bioanalytical Project Manager (BPM)/Principal Investigator (PI), overseeing all aspects of bioanalytical ... that shape the future of healthcare.Essential Responsibilities:Serve as Bioanalytical Project Manager (BPM)/Principal Investigator (PI), overseeing all aspects… more
- Merck & Co. (Durham, NC)
- …the Associate Director of Maintenance and Engineering or the shift Maintenance Manager , the Maintenance Specialist primary responsibility will be to help facilitate ... the facility.The Maintenance Specialist has the opportunity to develop into a manager with a rapidly growing pharmaceutical manufacturerThis position is an 8-hour… more
