- Merck & Co. (Rahway, NJ)
- …to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on ... the world.Looking for someone with a growth mindset.Position Description: The Senior Director , Global Regulatory Lead, is responsible for development and… more
- 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)
- …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
- 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
- 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
- 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
- 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)
- …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. (Millsboro, DE)
- …and unregulated species including chickens, turkeys, dogs, cats, rabbits, and rodents.Assure compliance with all federal and state regulatory requirements for ... Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro...company's Millsboro Animal Health facilities. This role is highly compliance -driven in accordance with State and Federal regulations as… 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)
- Job DescriptionThe US CA Veterinary Insights and Medical Affairs Director sets the strategic vision for the development, refinement, and implementation of veterinary ... of healthier animals in a highly competitive market.Reporting to the Executive Director , US CABU Professional Services, this position works closely with Marketing… 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
- 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
- Catalent (Philadelphia, PA)
- …and guidance to the Quality Disposition, Materials Sampling Quality Assurance, Regulatory and Compliance Quality Assurance, and Validation Quality Assurance. ... Position: Director QualityLocation: Philadelphia, PAPosition Summary: The Quality function...delivers reliable, high-quality products that meet all customer and regulatory agency requirements and expectations. Components of the quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Clinical Operations (GCO) Procedural Ownership and Life Cycle ... and policies, and meet applicable ICH and GCP standards. The Associate Director will also be responsible for the creation, management, and documentation of… 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. (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
- 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
- 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
- Eisai, Inc (Raleigh, NC)
- …microbiological assays.Thorough technical understanding of analytical laboratory compliance requirements and regulatory expectations.Demonstrated understanding ... and approve relevant technical documents, such as change controls, regulatory submissions, deviations, validations, method transfers, APRs, etc. as… more
