- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …health authorities. Represents DS in key interactions with Health Authorities. Ensures compliance of DS programs with regulatory requirements for diagnostics and ... centered around rare diseases and immune disorders. ResponsibilitiesEnsure global regulatory plans support a precision medicine approach eg integrated… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …supply chain of internal and external GMP manufacturing organizations.Ensures a satisfactory regulatory compliance level for these organizations for local and ... responsible for QA GMP activities pertinent to the overall compliance state of DS drug substance, drug product and...leadership to support the preparation, execution, and remediation of regulatory inspections of the sites. The incumbent leads a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to… more
- Merck & Co. (Rahway, NJ)
- …are completed with the highest regard for safety, quality and regulatory compliance .Qualifications:Education Minimum Requirement: This position requires either ... Job DescriptionDirector, Chemical Biotechnologies Description:The Director of Chemical Biotechnologies reports to the Senior Director Chemical Biotechnologies in… more
- Merck & Co. (Rahway, NJ)
- …all functions of our company while driving improvements and alignment for regulatory compliance worldwide.Responsibilities: Manage and provide leadership to a ... and our neighbors are not impacted.This role, reporting to the Executive Director of Environmental Compliance , Sustainability & Stewardship CoE will manage… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Director - Financial Planning & Analysis ( FP&A) , Research & Development Division IT / Chief Technology Office (CTO) Key ... capabilities to help our Company save and improve lives.The Director Research & Development Division IT and Chief Technology...Division IT spanning the LROP including Discovery, Clinical and Regulatory .This role also supports the SVP of the Chief… more
- Eisai, Inc (Nutley, NJ)
- …we want to hear from you. Job Summary: As the Americas IT Security and Compliance Director , you play a pivotal role in ensuring the organization's adherence to ... educating end-users on compliance requirements. Additionally, you manage regulatory compliance activities, maintain accurate documentation, and evaluate new… more
- Merck & Co. (Rahway, NJ)
- …and implement robust SAP security policies, procedures, and controls.Ensure compliance with regulatory requirements and industry best practices.Manage ... and overall role administration. This role reports to Executive Director , SAP Platform Team. Primary Responsibilities: Leadership and StrategyProvide strategic… more
- Merck & Co. (Rahway, NJ)
- …Division, and Global Workplace & Enterprise Services (GWES) to ensure compliance with regulatory requirements, corporate standards, policies and procedures ... Job DescriptionPosition Description: Director Safety & Environment The Rahway Environmental, Health, and Safety (EHS) Director is responsible for development and… more
- Merck & Co. (Rahway, NJ)
- …are completed with the highest regard for safety, quality and regulatory compliance .Qualifications: Education: Degree in engineering or related pharmaceutical ... Job DescriptionDescription:The Director of Chemical Engineering R&D is responsible for...plant scale-up and activities to support technology transfer and regulatory filings. The incumbent will be responsible for the… more
- Merck & Co. (Durham, NC)
- …activities while ensuring product quality and optimized maintenance processes, regulatory compliance , employee and environmental safety, integration of ... our core principle of Safety First and Quality Always.The Associate Director , Engineering/Maintenance will support a new drug substance manufacturing operation's… more
- Merck & Co. (Rahway, NJ)
- …Agile framework-and using JIRA to drive roadmap execution Strong understanding of regulatory frameworks and compliance standards related to identity management ... escalations and support transitions and enforce identity policies and standards. Foster compliance by providing guidance on the design and implementation of identity… more
- Merck & Co. (Rahway, NJ)
- …cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for ... of Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. Strategic… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …based on potential impact on product quality, patient safety, and regulatory compliance . Address recurring deviations and health authorities' observations ... in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the… more
- Merck & Co. (North Wales, PA)
- …environment or scrum frameworkMarket research knowledgeKnowledge of our commercial, regulatory , and legal compliance policiesEnd-to-end medical/legal (PRT) ... Job DescriptionThe Associate Director US Oncology Marketing Digital Engagement will direct...assetsImplementing Safety Label Updates on promotional assets and ensuring compliance with Subpart E regulations, when applicablePartnering with the… 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. (Rahway, NJ)
- …to bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The Director selects, trains, and ... Job DescriptionThe Director of Biologics Potency in Analytical Research &...strong network internally and across the external academic and regulatory community is expected, as well as advancing a… more
- Insmed Incorporated (San Diego, CA)
- …York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director of Program Management, the Associate Director , Program Management ... accordance with the program strategy. In addition, the Associate Director of PM may be asked to lead and/or...& objectives by ensuring program work is conducted in compliance with PMO processes and Company policies and leading… more
- Novo Nordisk Inc. (Chicago, IL)
- …Reimbursement), HEOR, Marketing, Commercial Sales, Medical Affairs, and Legal & Compliance . External relationships include Customers as outlined in the Purpose of ... pricing implications and downstream impact of the evolving public policy, government, regulatory landscape and other relevant trends Identifies and builds a broad… more
- Tris Pharma (Monmouth Junction, NJ)
- …use disorders, ADHD, etc.); Designs and implements clinical trials ensuring compliance with regulatory standards and industry best practicesOrchestrates and ... therapeutic area to serve as Senior or Executive Medical Director . Title and salary commensurate with experience. The Executive/Senior...manages clinical aspects of regulatory strategies and actively engages with Food and Drug… more
