- Merck & Co. (Rahway, NJ)
- …Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Primary ... Job DescriptionOur Regulatory Affairs team bring new medical advancements to...communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the… more
- UT Health Tyler (Tyler, TX)
- …Provides education to focus areas regarding Quality Monitoring and Improvement, Regulatory Compliance, Patient Safety , Risk Management, Medical Staff Services ... advancing healthcare, together. POSITION SUMMARY The position of Quality and Patient Safety Director at UTHET is accountable for assisting the organization to… 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
- Tris Pharma (Monmouth Junction, NJ)
- …and clinical trial databases Ensures audit and inspection readiness of Drug Safety team at all times; Ensures internal regulatory /PV processes and ... procedures are well documented and support compliant regulatory /PV activities Reviews safety data exchange and/or PV agreements with appropriate business… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to clinical studies, post-marketing surveillance, signal detection and management, important safety topics, and regulatory submissions. This individual will ... evaluation related documents/deliverables on time.- Coordinate and participate actively in safety -related regulatory interactions (eg, regulatory meetings,… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …at a pharmaceutical/biotechnology company.Knowledge and understanding of national and international regulatory guidelines and drug safety practices. Knowledge of ... of the Pharmacovigilance & Risk Management Team, the Senior Director, Medical Safety Physician will be responsible for monitoring and maintaining the safety… more
- Merck & Co. (Durham, NC)
- …transfer of the HPV vaccine manufacturing process while ensuring compliance with all regulatory and safety guidelines. Lead a diverse team and be accountable ... people that make our products. We work in the manufacturing plants with a " Safety First, Quality Always" mindset striving for continuous improvement. We work in the… more
- Eisai, Inc (Nutley, NJ)
- …experience with/using the following (which may have been gained concurrently): Supporting Regulatory and/or Safety functions in a global environment; Supporting ... Submissions Management, Labelling, Publishing and Registration tracking; Working with Regulatory Planners, Publishers, Safety Officers, Case Processers, Medical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … databases Contribute and support the evaluation of daily GXP lists for regulatory submission of individual case safety reports from both post-marketing and ... maintain local ( safety ) SOPs. Collaborate with Global Safety on global SOP updates and regulatory ...Global Safety on global SOP updates and regulatory changes Physical Requirements 0-10% overnight travel required. 0-10%… more
- Eisai, Inc (Nutley, NJ)
- …business processes. Responsible for approval of medical and scientific content of Regulatory , Safety , Scientific Affairs, Medical Affairs and Commercial outputs ... conduct of clinical studies in relevant therapeutic areaKnowledge of regulatory guidance regarding marketing/sales promotional materialsStrong overall written and… more
- Eisai, Inc (Nutley, NJ)
- …business processes. Responsible for approval of medical and scientific content of Regulatory , Safety , Scientific Affairs, Medical Affairs and Commercial outputs ... conduct of clinical studies in relevant therapeutic area.Knowledge of regulatory guidance regarding marketing/sales promotional materialsStrong overall written and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new ... colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT, etc.) is… more
- Merck & Co. (Rahway, NJ)
- …regulations, guidelines, and quality standards, including cGMP, FDA, and other regulatory requirements. Safety and Environment: Prioritize and maintain a safe ... work environment, implementing and monitoring safety protocols to protect employees and the surrounding community.Budget and Resource Management: Develop and manage… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This role is responsible for leading and mentoring a dynamic and global Regulatory Intelligence & Policy team, through direct and indirect line management, to ... corporate initiatives, ensuring that DS is prepared to meet new or proposed global regulatory requirements and that DS has a voice in defining new requirements. The… more
- Eco Recovery Solutions (Shrewsbury, MA)
- …Welding experience Licenses as required by State, Federal, environmental and/or health/ safety regulatory agencies Special Skills and Abilities Strong work ... operation Maintain and follow all Company environmental compliance, health and safety requirements, policies, procedures and rules Perform preventive and repair… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …and efficient utilization of the warehouse space. This individual will assist in regulatory inspections, perform safety and quality audits, and answer relevant ... operating procedures and work instructions and comply with cGMP regulations and safety guidelines. Requirements A minimum of a High School Diploma is required.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …generation, design and leadership of clinical development plans, and addressing all regulatory , drug and patient safety , data, CMC, IP, patient selection, ... overarching and competitive, asset strategy and execution to ultimately achieve global regulatory filings and ensure wide access of the compound. That strategy will… more
- Merck & Co. (North Wales, PA)
- …with internal and external stakeholders including Statistics, Clinical Research, Regulatory , Observational Research, Clinical Safety and PK/PD Modeling ... internal stakeholder groups including the Outcomes Research and Clinical Safety organizations.Lead and actively contribute to departmental strategic initiative… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and ensures the study designs are scientifically sound, the efficacy and safety information meets regulatory requirements of the countries and Regions ... logical, scientifically sound, proposed studies have appropriate designs, efficacy and safety information to be collected meet regulatory agencies' requirements… more
- Satellite Shelters (Dahlonega, GA)
- …and modification of truck components and systems to meet performance, safety , and regulatory requirements.Prototype Development: Collaborate with the engineering ... related to automotive or mechanical engineering is a plus.Familiarity with regulatory standards and requirements for automotive vehicles.Ability to adapt to a… more
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Senior Manager Safety Regulatory