- Daiichi Sankyo, Inc. (Bernards, NJ)
- …applications meet strict regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and driving ... while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This… more
- BioAgilytix (Durham, NC)
- …to meet regulatory requirements, including HIPAA, GxP, GDPR, and FIRPA.Design data quality KPIs and implement initial quality checks independently, ... diagnosing data challenges and designing innovative solutions to improve data quality , integration, and regulatory adherence.Capable of growing with the… more
- Merck & Co. (Rahway, NJ)
- …skills include but are not limited to: - Serve as a Combination Product Regulatory Lead and provide leadership within Regulatory and cross-functional teams ... injectables; pre-filled syringes and/or autoinjectors. -- The successful candidate will lead the development and the implementation of regulatory strategies… more
- Genmab (NJ)
- …driver for inspection readiness, regulatory compliance, and successful data submissions.The Associate Director will lead cross-functional collaboration, ... to have you join us!The RoleThe Associate Director, External Data Quality Management, is a strategic leadership...inspection readiness, and regulatory compliance.Act as a Data Standards or Clinical Systems Lead as… more
- Merck & Co. (Durham, NC)
- … quality without compromising superior customer service. FUNCTIONAL EXPERTISE: Lead in the identification and implementation of process improvement projects, ... Job DescriptionThe Utilities Electrical Engineering Lead is a member of the Plant Engineering...preventative and predictive maintenance programs to assure compliance with quality , regulatory , and reliability requirements and goals.Track… more
- Merck & Co. (Rahway, NJ)
- …sound processes and procedures, and to provide independent assurance that delivers high quality data and clinical supplies. - The Compliance and Quality ... execution of critical activities in the areas of compliance, quality systems, regulatory intelligence, and the ...providing recommendations for continuous improvement. - Mon ito r data quality and a dministrative activities related… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to database release, data review and cleaning, database lock), to ensure data quality /integrity and regulatory complianceEnsures that Data Management ... global data management strategy across regions and across studies/programs. Lead DM resource model internalization for both strategy and implementation in terms… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the Novo Nordisk US Operations (USO) AI Center of Excellence. The individual will lead and manage a team of data scientists, including AI/ML experts and ... evolve the Data Science team to meet internal and market needs. Lead a high-performing, collaborative team environment.Core member of the AI Center of Excellence,… more
- Genmab (NJ)
- … control experience in the pharmaceutical/biotech industry, specifically, experience performing quality control checks to ensure data integrity of clinical ... have you join us!The RoleThis individual supports content QC of regulatory and clinical documents in the Medical Writing group.ResponsibilitiesIndependently edit,… more
- Tris Pharma (Monmouth Junction, NJ)
- …has an immediate opening for a SR. Manager or Manager, Quality Management Systems (QMS). Title commensurate with experience.Summary:This position supports, oversees ... and manages the Quality Assurance (QA) Investigations and Product Quality ...(OOS/OOT/Lab Event) and manufacturing investigations and CAPAs/CPIs Performs in-depth data analysis to identify compliance concerns, root causes and… 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
- Twist BioScience (South San Francisco, CA)
- …solutions across our biomanufacturing operations. This critical role will drive efficiency, quality , and robust data integrity within a highly automated ... closely with the platform architecture and infrastructure teams, Manufacturing Operations, Quality Assurance, Process Development, and Regulatory Affairs teams… more
- Merck & Co. (Rahway, NJ)
- …DescriptionOur Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new ... indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and… more
- Formation Bio (New York, NY)
- …role in scaling our biologics capabilities in partnership with technical, quality , and regulatory leaders.Responsibilities Strategic Leadership Develop and ... and commercial-stage biologic products, ensuring alignment with company goals and global regulatory standards. Team Development Build and lead a high-performing… more
- Merck & Co. (South San Francisco, CA)
- …Sciences, Pharmacology, Pharmacometrics, PKPD Modeling, Population Pharmacokinetics, Quality Management, Regulatory Applications, Stakeholder Relationship ... development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced… more
- Eisai, Inc (Nutley, NJ)
- …we want to hear from you. Director, HCP Marketing, Alzheimer's Disease will lead several core marketing, strategy, and lifecycle planning projects focused on the ... This role represents a key opportunity for a talented, passionate marketer to lead important and innovative commercial work streams for a highly visible AD brand.Job… more
- Merck & Co. (Durham, NC)
- …and implementation of troubleshooting activities and change control. Initiate and lead collaboration within the Operations, Quality and Technical organizations ... querying), DeltaV SIS Experience working with Information Technology teams. Experience with regulatory audits and working knowledge of data integrity principles.… more
- Eisai, Inc (Nutley, NJ)
- …and data monitoring to ensure successful implementation of high- quality clinical development programs. Lead and manage moderately complex clinical ... and provide input into clinical issues, adverse events, laboratory data and patient inclusion/exclusion criteria.Adapt and present complex scientific findings… more
- Aequor (Bothell, WA)
- … data integrity, cyber security, and defend work before regulatory agenciesEnsure alignment with Client directives and industry guidelines for applicationsExecute ... as well as site and global applications used within the manufacturing, quality , and quality control organizations.This position requires a passion for… more
- Genmab (NJ)
- …of high- quality clinical documents to support operational, medical, and regulatory activities across the Genmab portfolio. You will help craft scientifically ... part of a dynamic, collaborative team that values innovation, quality , and scientific integrity? At Genmab, we are seeking...the story of our science through compelling clinical and regulatory documents. You'll be at the heart of a… more
