- Eisai, Inc (Exton, PA)
- …CTAs) and agency communications (responses to questions) are prepared in compliance with the applicable regulatory requirements and scientific ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...Job Summary Implements global chemistry, manufacturing and control (CMC) regulatory strategies throughout the lifecycle of pharmaceuticals. Coordinates the… 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
- Merck & Co. (North Wales, PA)
- …lead continuous process evaluation/optimization, metric development, collection and monitoring compliance of assigned process with input from Subject Matter Experts, ... of responsibility within assigned cross functional process to optimize compliance .Oversees communication and informational efforts to cross divisional contributors… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Role OverviewThe Quality Compliance - Lead Auditor CAR-T 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
- 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
- Novo Nordisk Inc. (Atlanta, GA)
- 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 ... rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT)… more
- Merck & Co. (North Wales, PA)
- …using health literate language per company process and standards to ensure compliance with internal policy, regulatory requirements, and health literacy ... Job DescriptionThe Medical Writing & Disclosure Department of the GCTO...documentation in support of the clinical development portfolio and compliance in public disclosure of clinical trials and their… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …GPV, GDP, and adherence to safety requirements are adequately considered for all Medical Affairs programs. Interact with legal and compliance as required. ... 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. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Program Leadership and Technical ... performance of team members, fostering a collaborative and innovative team environment. Regulatory Compliance and Quality Assurance:Ensure that all activities are… more
- Eisai, Inc (Toledo, OH)
- …to work independently and not require close supervision while adhering to compliance / regulatory policies. Interest in leading and participating in projects while ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...your profile, we want to hear from you. The Medical Science Liaison (MSL or Sr. MSL) is a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …amount of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service ... various contractors meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global… 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 ... Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …address regulatory requirements, and shape product development strategies Regulatory Compliance : Ensure early commercialization strategies comply with ... and Early Development Lead. Collaborates with cross-functional teams, including marketing, medical , R&D, regulatory affairs, finance, Market Access (MAPA) and… 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
- Novo Nordisk Inc. (Boulder, CO)
- …Lead on site emergency coordinators Conduct routine safety observations to ensure compliance with regulatory agencies, company environmental, health, and safety ... local regulatory agencies preferred Familiarity with technologies to ensure compliance The base compensation range for this position is $125,000 to $150,000.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to regulatory process optimizations on relevant topics.Responsibilities- Supports CMC regulatory compliance activities for portfolio biologics to meet US, ... with cross functional teams and various departments to include Marketing, Medical Affairs, Regulatory Affairs, Supply Chain Technical Operations, Pharmaceutical… more
- Tris Pharma (Monmouth Junction, NJ)
- …strategic leadership and direction for Clinical Quality Assurance Operations, ensuring compliance with regulatory standards and driving implementation and ... trial/study regulatory requirements and processes in both Pharma and Medical DevicesExperience in developing SOPs , reviewing internal clinical, regulatory ,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …enhance TA-specific customer experiences; building strong cross-functional relationships; ensuring compliance to Legal, Regulatory and industry standards; ... stakeholders across the organization including Commercial Excellence, CIA, IT, Sales, Medical , Legal, and Regulatory . Essential Functions Customer Engagement… 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
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