- Legend Biotech USA, Inc. (Raritan, NJ)
- …to prioritize investigations based on potential impact on product quality, patient safety , and regulatory compliance . Address recurring deviations and ... myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical Operations team based… more
- Merck & Co. (Rahway, NJ)
- …an effective implementation and oversight model to maintain best-in-industry regulatory compliance .The Vice President Regulatory Affairs, ... contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function...in the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.Providing… 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...party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company… more
- 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 ... Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Primary… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Overview The Quality Compliance - Lead Auditor CAR-T is responsible for regulatory compliance supporting the production of autologous CAR-T products for ... independent audits; manage audit responses and observation resolution. Drive site compliance to regulatory , enterprise, and global requirements through building… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for ... rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT)… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …requirements Continuously monitor and improve documentation and processes to ensure compliance with regulatory requirements and Novo Nordisk standards. Work ... Maintain system documentation and process according to Novo Nordisk standards and in compliance with regulatory requirements Participate as an CSV SME in audits… more
- Catalent (Philadelphia, PA)
- …material management of materials at Catalent-Philadelphia. Assist in the enforcement of regulatory compliance through state, FDA, DEA, CDC, and USDA ... a Patient First culture through excellence in quality and compliance , and to the safety of every...Distribution Summaries/Checklists, and Returns Protocols (as required). Audit for compliance as pertains to Catalent SOPs, regulatory ,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Access Programs, Investigator initiated studies and Collaborative Research.Support adherence to regulatory safety requirements for all programs (ie post ... quality support across programs ensuring GCP, GPV, GDP, and adherence to safety requirements are adequately considered for all Medical Affairs programs. Interact… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …preventative maintenance (PM) & predictive maintenance (PDM) practices to ensure compliance (cGMP) with company policies and appropriate regulatory standards ... Partner and manage relationships with contractors to ensure quality of work and compliance with all company policies and regulatory guidelines Develops metrics… more
- Insmed Incorporated (Bridgewater, NJ)
- …different therapeutic areas, ensuring alignment with company objectives and in compliance with regulatory guidelines and industry standards. Provide scientific ... lists.OverviewOverview The Director, Toxicology, is a key member of the nonclinical safety team, reporting to the Executive Director, Head of Toxicology and… more
- Merck & Co. (Durham, NC)
- …candidate should be able to examine an issue from diverse perspectives ( safety , compliance , automation, equipment, process, and people) to best understand ... many diverse areas including Biologics, Automation, Capital Projects, Maintenance, Safety , Process Development, Technical Services, Utilities and Validation. Position… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and execution of clinical trials, the drafting of medical/ scientific documents, safety monitoring, and data analyses. In this high visibility position, the ... Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure requirements are in place for quality ... risk-based assessment for Distributors, co-partners, and affiliates. Liaise with Audit and Compliance team to ensure that GVP audits are planned, communicated and… more
- Merck & Co. (Durham, NC)
- …own unit. Compliance - Creating and sustaining a culture that ensures that compliance ( Safety , Environment, cGMP, etc.) are imperatives for the business - ... a quality product at a competitive cost consistent with our Company, Regulatory Agency, and State and Local code requirements for quality, good manufacturing… more
- Catalent (Philadelphia, PA)
- …and employee safety , will assist in the enforcement of GMPs and regulatory compliance through FDA and Catalent requirements, and will provide customer ... a Patient First culture through excellence in quality and compliance , and to the safety of every...records, etc; Respond to and investigate customer complaints.Audit for compliance as pertains to Catalent SOPs, regulatory ,… more
- Aequor (Davie, FL)
- …(Word, Access, excel, Powerpoint, Projects and Visio). Ensuring compliance with all company policies and procedures, including safety rules and regulations. ... current processes. Has in-depth understanding of pharmacological, chemical, medical, compliance , legal, and industry factors. RESPONSIBILITY All areas of… more
- Insmed Incorporated (Bridgewater, NJ)
- …associated amendments and Special Protocol Assessment (SPA) Agreements in compliance with Clinical Development Plans and regulatory requirements.Provide ... program level medical oversight of information included in regulatory documents including clinical sections of IND submissions, IND Annual Updates / DSUR,… more
- UT Health Tyler (Tyler, TX)
- …Education: Provides education to focus areas regarding Quality Monitoring and Improvement, Regulatory Compliance , Patient Safety , Risk Management, Medical ... and makes recommendations for system improvements using quality data, event and regulatory compliance reports. Provides project management to assigned teams by… more
- Merck & Co. (Durham, NC)
- …for daily support and oversight of all production processes to ensure compliance with regulatory requirements as well as policies and procedures.-Responsible ... for establishing processes that ensure required safety guidelines are followed.-Review and approve qualification/validation documents for equipment and process (ie,… more
