- Merck & Co. (Rahway, NJ)
- …device and combination products, guiding cross-functional teams to ensure regulatory compliance throughout development and commercialization. Mentor team ... Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development Programs. You will spearhead regulatory … 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… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational...development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates 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… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Raritan, NJ. Role OverviewThe Quality Compliance Manager is responsible for regulatory compliance supporting the production of autologous CAR-T products for ... and independent audits; manage audit responses and observation resolution.Drive site compliance to regulatory , enterprise, and global requirements through… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within Patient Support Programs, Patient Safety, Quality, NNI IT and Telephony, Medical Information, Compliance , Regulatory , Legal and Privacy. External ... Functions Partners with PSS Program Management team to ensure vendor compliance with all quality/safety requirements; educates on process requirements Partners with… more
- Tris Pharma (Monmouth Junction, NJ)
- …promotional materials, activities and related communications and programs are in full compliance with Medical , Legal, Regulatory and Corporate guidelines; ... compliant communication between marketing and other cross-functional teams (ie, Medical Affairs, Sales, Regulatory Affairs, Operations, etc.)Collaborates closely… more
- Tris Pharma (Monmouth Junction, NJ)
- …and compliance guidelines and ensures knowledge of legal and regulatory requirements to appropriately respond to medical inquires, disseminate scientific ... in positions of increasing technical and strategic responsibilityExcellent working knowledge of regulatory and industry standards related to Medical Affairs role… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Merck & Co. (North Wales, PA)
- …strategies, processes, and systems for a pharmaceutical company, ensuring compliance with regulatory requirements and maintaining high-quality standards.- ... regulatory requirements and ensure patient safety, quality and compliance .-Oversee PV processes: Responsible for overseeing all PV processes, including adverse… more
- Merck & Co. (Rahway, NJ)
- …pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product ... robust scientific methodology we collaborate to discover and develop the next medical breakthrough. Our success is backed by ethical integrity, forward momentum, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... rare diseases and immune disorders. Summary This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …such as Diabetes and Bio Pharm Field Sales, Managed Care, Trade and Government, Medical , Regulatory , Legal personnel and may advise Global Teams with regard to ... new Market Development and HCP Engagement processes to meet changing regulatory requirements, and establish appropriate compliance training and communications… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across all CMR functions, and compliance across clinical development, medical , and regulatory roles/processes/SOPs Develop and implement knowledge management ... About the Department The Clinical, Medical and Regulatory (CMR) department at...existing CMR employee on-boarding, cultural engagement, technical/role-specific training and GxP/ Regulatory compliance across CMR functions. Position will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulatory standards, contributing to the organization's success and regulatory compliance .ResponsibilitiesCoordinate global regulatory dossier generation ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...is to lead and/or support complex filing activities, ensuring compliance with technical and regulatory standards. This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... members to ensure that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead(s) (GQLs) and Regional Quality Leads (RQLs),… 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… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and manage relationships with contractors to ensure quality of work and compliance with all company policies and regulatory guidelinesHelp improve metrics ... PLCs, VFDs and electrical practices generally attained through hands-on experience, cGMP compliance , EHS and regulatory standards (eg EPA, OSHA and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Innovation, as well as Therapeutic Area leads, Sales, Patient Support Program, CIA&A, Medical , Legal, and Regulatory and IT. Essential Functions Portal Strategy ... This involves collaborating with Experience Operations, Omnichannel Orchestration, TA/Brands, Medical /Legal/ Regulatory , Privacy, and agencies d to implement new… more
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