- Merck & Co. (Upper Gwynedd, PA)
- …of clinical development, including study design, placement, monitoring, analysis, regulatory reporting , and publication. -- Responsibilities: Specifically, the ... closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects;… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …timelines.Develop quality systems and procedures for the signaling activities to assure regulatory compliance and meet regulatory reporting timelines. ... processes across the global safety organization. The incumbent will ensure regulatory compliance, promote best practices, foster a culture of continuous improvement… more
- Genscript USA Inc. (Piscataway, NJ)
- …for site staff, contractors, and project teams. Support permit applications and regulatory reporting . Lead site inspections, audits, and emergency drills. Serve ... risks. Ensure compliance with OSHA, EPA, and other applicable regulatory agencies. Conduct risk assessments, hazard analyses (eg, JHA,...as a liaison with regulatory bodies and external contractors/vendors. Drive continuous improvement in… more
- Tris Pharma (Monmouth Junction, NJ)
- …monthly, quarterly and annual consolidated financial statements; Assists with regulatory reporting , as applicableResearches and corrects accounting issues ... support in ensuring company financial records remain accurate while meeting reporting deadlines. The incumbent establishes and approves internal controls and… more
- Lundbeck (North Hyde, SD)
- Lundbeck Australia is currently seeking a highly motivated and experienced Regulatory Affairs Manager to lead and manage regulatory activities across our product ... portfolio. This role is critical in ensuring compliance with local regulatory requirements for Lundbeck's products, overseeing regulatory submissions,… more
- Merck & Co. (Rahway, NJ)
- …Pharmacovigilance, Pharmacy Regulation, Punctuality, Regulatory Communications, Regulatory Compliance, Risk Management, Risk Reporting , Software ... PV team. The successful candidate will participate in case processing and reporting , support aggregate reporting and risk management activities, help maintain… more
- Merck & Co. (Millsboro, DE)
- …actions to prevent recurrence.Maintain records of incidents and ensure proper reporting to relevant regulatory authorities as required.Conduct regular ... Biosafety, EHS Auditing, EHS Compliance, EHS Program Management, Environmental Regulatory Compliance, Health and Safety Legislation, Incident Investigations, Industrial… more
- Petco (Brooklyn, NY)
- …payroll goals, and complete workload.Review and interpret financial and operational reporting regularly, including Pet Care Center visits and audit results.Identify ... areas and could be subject to variation based on regulatory minimum wage requirements. Actual pay rates will depend...applicable state or local minimum wage laws. If the regulatory minimum wage exceeds the minimum indicated in the… more
- Merck & Co. (North Wales, PA)
- …Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on document production ... of 10 years of industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated environment OR… more
- Merck & Co. (Rahway, NJ)
- …design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/ ... designing and analyzing clinical trials in support of worldwide regulatory submissions.This position involves interaction with Medical, Data Coordination,… 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 ... predominantly includes the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings,… 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. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... predominantly includes the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings,… more
- Merck & Co. (Rahway, NJ)
- …and biologics commercialization within the expansive Biologics S&T portfolio. Reporting directly to the Biologics Drug Substance Commercialization Leader, you ... oversight of DS & cell banking process development, process characterization and regulatory filing activities to ensure a smooth and clear path to successful… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary: Reporting to the Sr. Director, Medical Affairs QA, the Director of Medical ... Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high impact projects, fostering s culture of… more
- BioAgilytix (Durham, NC)
- …that boost lab productivity and keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data ... build quality assurance processes, and monitor data integrity to meet regulatory requirements, including HIPAA, GxP, GDPR, and FIRPA.Design data quality KPIs… more
- Merck & Co. (North Wales, PA)
- …drug/vaccine clinical development projects.Develop and execute statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, ... span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.-Design and maintain statistical… more
- BioAgilytix (Durham, NC)
- …ISO 27001).Oversee governance, risk, and compliance activities, including policy development, regulatory alignment (GxP/CLIA, GDPR, Part 11), and global data privacy ... vendor and third-party security risk, ensuring adherence to contractual and regulatory obligations.Define guardrails for AI and new technologies, including M365… more
- Insmed Incorporated (San Diego, CA)
- …Biometrics teams, Clinical Operations teams, Clinical Development teams, Regulatory Affairs, and external partners.ResponsibilitiesEDC System Design & ... & Integration:Partner with internal data teams to support automation, reporting , and data exchange solutionsEnsure all programming solutions comply with… 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 ... function areas. Primary Activities :Prepare compliant programming code for regulatory submissions including analysis/modeling datasets, tables, listings, figures and… more
