- 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- …Mentorship, Neuroanatomy, Pharmaceutical Development, Pharmacovigilance, Psychiatry, Regulatory Affairs Compliance , Regulatory Compliance , Regulatory ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing… more
- Tris Pharma (Monmouth Junction, NJ)
- …coordinates and advances required documentations, in liaison with Product Development (PD)/ Quality Assurance (QA)/ Quality Control (QC)/ Regulatory Affairs, ... New Jersey, Tris has an immediate opening for a Method Validation R&D Senior Scientist ISummary:The Method Validation (MV) Research and Development (R&D) Senior … more
- Merck & Co. (Boston, MA)
- …to accelerating research and innovation.- We are seeking a passionate and knowledgeable Senior Specialist to join our Library team.- In this position, you will be ... by linking our stakeholders with scientific and medical information resources. A successful Senior Specialist will have a drive for mastering a wide range of… more
- Merck & Co. (Rahway, NJ)
- …US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to stakeholders ... and effective implementation and oversight model to maintain best in industry regulatory compliance .The Vice President Regulatory Affairs, General Medicine… more
- Merck & Co. (South San Francisco, CA)
- …AI (GenAI) to enhance document authoring processes, thereby improving efficiency and compliance in regulatory submissions.The candidate will play a key role ... developing, implementing, and optimizing GenAI approaches to streamline the creation and quality control (QC) of regulatory submission documents. The candidate… more
- Merck & Co. (Rahway, NJ)
- …The scientist will be expected to exhibit a mindset of safety and quality compliance , which will include following current Good Manufacturing Practices (cGMPs), ... factory settingExperience with mathematical modeling, theoretical scaling calculations, and Quality by Design (QbD) principles.-Experience supporting/writing regulatory … more
- Merck & Co. (North Wales, PA)
- …Guidelines, Life Science, Medical Writing, Motivation Management, Ophthalmology, Prioritization, Regulatory Compliance , Regulatory Documents, Rheumatology, ... Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and integrity of trial conduct.Providing tactical/scientific mentorship… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …systems while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance ... systems, electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality … more
- Merck & Co. (Rahway, NJ)
- …in Rahway, New Jersey.The Sterile Process Engineer role at the Senior Specialist level will leverage the individual's leadership, technical, and communication ... selected candidate will lead and contribute to the launch and regulatory certification of the facility, concluding startup and operational readiness activities.Once… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... under supervision in Late Development Statistics. --Interacts with Clinical, Regulatory , Statistical Programming, Data Management and other company Research… more
- Formation Bio (New York, NY)
- …early development through commercialization. You will oversee internal and external teams, ensure regulatory compliance , and play a key role in scaling our ... development, formulation, analytical methods, and technology transfer to manufacturing sites. Regulatory Compliance & Submissions Ensure all CMC activities… more
- Tris Pharma (Monmouth Junction, NJ)
- …inventory control systems to maintain optimal stock levels and minimize obsolescence; Ensures compliance with safety, quality , and regulatory standards in ... negotiations, supplier relationship management, procurement systems functionality/workflows and assurance of compliance with GxP and other company and regulatory … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionResponsibilities:Provide high quality statistical programming deliverables for global stakeholders in Early Development Statistics and PK/PD Modeling ... other related function areas. Prepare compliant programming code for regulatory submissions including analysis/modeling datasets, tables, listings, figures and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across the Novo Nordisk US Operations, including ED&AA, IT, Ethics and Compliance , Commercial, Patient Services, CMR (Clinical, Medical, Regulatory ), Finance, ... cutting-edge AI/GenAI technologies and developing AI/GenAI products to deliver high quality insights with speed and efficiency Promotes a culture of creativity… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …full alignment across internal and external stakeholders and partners Maintain robust compliance , quality and privacy standards in handling customer information ... you in? Are you ready to experiment with us? The Position The Senior Manager, Patient Support Data Intelligence is responsible for process improvement, technology,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the ... within R&D. Reviews and provides guidance to RBQM projects. Accountable for the quality and timeline for all RBQM deliverables. Promotes, oversees and is accountable… more
- Merck & Co. (North Wales, PA)
- …management concepts Experience in CDISC and ADaM standards Experience ensuring process compliance and deliverable quality Strategic thinking - ability to turn ... Preferred Skills and Experience: Demonstrated success in the assurance of deliverable quality and process compliance . Strong working knowledge of reporting… more
- Repligen (Waltham, MA)
- …audit schedules; serve as host for site auditsMaintain risk-based strategy for overall Quality compliance across the organization and in support of the ISO ... including deviation support, root cause analysis, customer complaint management, hosting customer/ regulatory audits and Certificate of Quality generation at an… more
