- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and submission plans), including HA engagement plans and mitigation strategies.Ensure high quality collaboration global regulatory leads and provides guidance to ... health authorities. Represents DS in key interactions with Health Authorities. Ensures compliance of DS programs with regulatory requirements for diagnostics and… 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 ... collaboration with Global External Supplier QA teams.Collaborate with Global Quality Management System (QMS) teams on regulatory -related...to recommend metrics and report the state of GMP Quality and compliance of Daiichi Sankyo and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes ... 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
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …risk assessments to prioritize investigations based on potential impact on product quality , patient safety, and regulatory compliance . Address recurring ... in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the… more
- Catalent (Philadelphia, PA)
- …guidance to the Quality Disposition, Materials Sampling Quality Assurance, Regulatory and Compliance Quality Assurance, and Validation Quality ... Position: Director QualityLocation: Philadelphia, PAPosition Summary: The Quality...and effective quality system that delivers reliable, high- quality products that meet all customer and regulatory… more
- Merck & Co. (Rahway, NJ)
- …all team activities are completed with the highest regard for safety, quality and regulatory compliance .Qualifications:Education Minimum Requirement: This ... Job DescriptionDirector, Chemical Biotechnologies Description:The Director of Chemical Biotechnologies reports to the Senior Director Chemical Biotechnologies in… more
- Merck & Co. (Millsboro, DE)
- …DNREC, etc.) of animal facilities and program reviews is required.PurposeThe Associate Director /Attending Veterinarian will report to the Site Quality Head/ ... Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro...species including chickens, turkeys, dogs, cats, rabbits, and rodents.Assure compliance with all federal and state regulatory … 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 &...product development, control strategy, and specifications-setting.-Deep working knowledge of regulatory guidance and quality standards, with experience… more
- Merck & Co. (Rahway, NJ)
- …that all team activities are completed with the highest regard for safety, quality and regulatory compliance .Qualifications: Education: Degree in engineering ... 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. (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)
- …CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and manufacturing is essential.The successful ... and retaining diverse talent.Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related to product release and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes ... tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …sites to ensure all trial deliverables are met according to timelines, budget, quality standards and in compliance . Proactively track, monitor and report trial ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- ContinueCARE Hospital at Palmetto Health Baptist (Columbia, SC)
- …and manages the ongoing, hospital-wide Quality program to ensure compliance with accrediting and regulatory agencies. Develops, implements and manages ... policies, procedures, and programs. Gathers, disseminates, documents and reports information quality metrics to facilitate compliance with requirements of 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 ... and will drive the development, creation, and implementation of high quality , global, coordinated cross-functional project plans for products in accordance with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Global Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources , and stability, uniting the best of both worlds to ... incumbent will help develop multiple products. In doing so, the Senior Medical Director will work across different functional teams to support the design and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for the development, maintenance, ... and enforcement of data standards, demonstrated knowledge of industry standards related regulatory requirements (CDISC), FDA & ICH, PMDA, EU & ICH, CRP and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the CMR training strategy Ensuring CMR employees receive training on regulatory compliance , quality standards, GxP requirements and industry-specific ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one...representative; Liaise with global and HQ counterparts to promote quality and consistency across regions. Ensure compliance … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …preferredExperience with process mapping tools (eg, Visio, Power Point), and Veeva Quality Docs requiredUnderstanding of regulatory and industry guidance and ... areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Clinical Operations (GCO) Procedural Ownership and Life Cycle… more
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