- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global ... and compliant with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality , CSPV, Clinical Operations,… 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Mondelez International (Richmond, VA)
- …Join our Mission to Lead the Future of Snacking. Make It With Pride. The Quality and Regulatory Compliance Manager ensures effective deployment of MDLZ ... regulatory and Mondelez' requirements for Food Safety and Quality . Ensure the facility is audit-ready for internal and...advice on risk management interactions with authorities, Plant Sr. Quality and Food Safety Manager and Corporate… more
- Merck & Co. (Rahway, NJ)
- …Payments Manager will help lead the strategic direction, operational quality , and innovation of the credit union's payments ecosystem, including card services, ... critical role in driving member satisfaction, improving efficiencies, and ensuring regulatory compliance while advancing the credit union's payments strategy in… more
- Merck & Co. (Rahway, NJ)
- …( as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines ,- ... arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of contact… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …deriving from these contracts. Organize and conduct periodic review of contract quality and adherence PV Regulatory Intelligence:Contribute to the management of ... language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of… more
- Merck & Co. (Rahway, NJ)
- …supplies . - Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply ... the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans for all activities… more
- Genmab (NJ)
- …of high- quality clinical documents to support operational, medical, and regulatory activities across the Genmab portfolio. You will help craft scientifically ... part of a dynamic, collaborative team that values innovation, quality , and scientific integrity? At Genmab, we are seeking...are seeking a passionate and experienced Senior Medical Writing Manager to help us tell the story of our… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance, GCP/Document Audits supports end-to-end audit activities ... File (eTMF) and other pivotal documents to be submitted to the regulatory authorities for application Qualifications: Successful candidates will be able to meet… 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 ... to standards of data and produces well-structured, high quality data summaries in tables, figures and listings for...of at least one study are in scope.The Programming Manager will support the Data Management, Statistics, Drug Safety,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …related to US Talent Acquisition. Ensures utilized solutions are compliant with regulatory requirement and advises on the same. Ensures Talent Acquisition functions ... and continually improve data representation and delivery applications (including data quality ) in support of US Talent Acquisition Evaluates processes within Talent… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and performance management ... size.Responsible for multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics; these metrics will… more
- Merck & Co. (North Wales, PA)
- …study materials (eg, ICF documents / amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection in alignment ... Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and integrity of trial conduct.Providing tactical/scientific mentorship… more
- Merck & Co. (Rahway, NJ)
- …(e . g . , ICF documents/ amendments); Partners with the Study Manager on study deliverables. Ensuring CRF design supports data collection in alignment with ... Management/Programming. Collaborating cross-functionally to monitor clinical data -to ensure quality , completeness , and integrity of trial conduct. Providing… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs.--The AVP provides leadership and direction through senior-level and… more
- Merck & Co. (Rahway, NJ)
- …CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and manufacturing is essential.The successful ... of Company policy. The Executive Director will be a manager of managers, with keen focus on coaching and...diverse talent.Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related to… more
- Aequor (Thousand Oaks, CA)
- …systems, and procedures. Interfaces across functions including Supply Chain, Manufacturing, Finance, Regulatory , and Quality at various level of detail, to ... EOD Weds 7/23 Standard business hours Supply Chain Senior Manager - Global Supply Chain Leader What you will...the end-to-end supply chain oversight of products, the Senior Manager will be responsible for establishing supply chain resolutions… more
