- Merck & Co. (Rahway, NJ)
- …Devices, Mentoring Staff, Ophthalmology, Pathophysiology, People Leadership, Physiology, Program Management , Regulatory Affairs Compliance {+ 4 more}-Preferred ... Job DescriptionPosition Description:The Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory … more
- Aequor (Thousand Oaks, CA)
- …degree and a minimum of 2 years of hands-on experience in document management , including workflow coordination and system administration. Proficiency with ... Viva or comparable document management platforms is required. Strong background... of R&D controlled documents to ensure compliance with regulatory standards and internal quality procedures. This role emphasizes… more
- Christus Health (Beaumont, TX)
- …through extensive interaction with physicians, patient caregivers and health information management coding staff to ensure that reimbursement is received for the ... as promulgated by state and federal agencies, the hospital, and other regulatory entitiesPerforms all duties in a manner that protects the confidentiality of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …assures the quality of the material content of any documents sent to regulatory authorities. Provides compliance metrics to management , as needed.Lead continuous ... to ensure benefit-risk integration to ensure signal, epidemiological data, and regulatory requirement synthesize into a coherent risk management … more
- Merck & Co. (North Wales, PA)
- …project progression, coaching on Company processes relating to CMC development team management , strategic document preparation, PM skills, and Team Management ... Pharmacodynamics, Pharmacology, Portfolio Optimization, Product Development, Project Budgeting, Project Management , Project Planning, Project Scheduling, Project Strategy, Regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Practice and regulatory compliance in such arrangements. Contribute to the management of PV Regulatory Intelligence (PVRI) and dissemination across CSPV ... contracts. Organize and conduct periodic review of contract quality and adherence PV Regulatory Intelligence:Contribute to the management of PV Regulatory … more
- Merck & Co. (Lower Gwynedd, PA)
- … System (LIMS), Laboratory Investigations, Process Improvement Projects, Project Management , Regulatory Compliance, Regulatory Strategy Development, ... utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. -As the AdVAnce facility will not be fully constructed and… more
- Tenethealth (Detroit, MI)
- …prevent avoidable readmissions. This position integrates national standards for case management scope of services including: Transition Management promoting ... and at appropriate level of care Compliance with state and federal regulatory requirements, TJC accreditation standards and Tenet policy Education provided to… more
- Merck & Co. (Lower Gwynedd, PA)
- …Quality Auditing, Regulatory Communications, Regulatory Compliance, Regulatory Training, Technical Documentation Management , Training Delivery, Working ... utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. -As the AdVAnce facility will not be fully constructed and… more
- Merck & Co. (Rahway, NJ)
- …Warehouse Development, Design Applications, Digital Transformation, ICT Strategy, Information Management , IT Coordination, Regulatory Documents, Regulatory ... and supply.A key workstream within this initiative is the auto-generation of regulatory filing sections, enabled by a dedicated application designed to create a… more
- Merck & Co. (Lower Gwynedd, PA)
- …including the biological sciences, computer sciences, medical technology, business management , etc.-Responsibilities-Strong knowledge of document or training ... Training Programs, Global Communications, Immunoassays, Information Technology (IT) Infrastructure, Management Process, Oral Communications, Pharmaceutical Regulatory Affairs,… more
- Merck & Co. (Lower Gwynedd, PA)
- …utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. -As the AdVAnce facility will not be fully constructed and ... data. -May review data generated by others-Understand and apply regulatory /compliance/scientific requirements relative to their role-May publish and/or present… more
- Merck & Co. (Lower Gwynedd, PA)
- …utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings.- As the new facility will not be fully constructed and ready ... of laboratory processes and data to ensure compliance with existing regulatory regulation and departmental SOPs- Required Experience & Skills -Experience with… more
- Genmab (NJ)
- …MS-Office Suite and Adobe Acrobat application and ability to work in electronic document management systemFor US based candidates, the proposed salary band for ... a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading… more
- Merck & Co. (Lower Gwynedd, PA)
- …utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. -As the AdVAnce facility will not be fully constructed and ... laboratory processes and data to ensure compliance with existing regulatory regulation and departmental SOPs-Required Experience & Skills-Experience with molecular… more
- Christus Health (Tyler, TX)
- …the Radiology Medical Director, understand patient assessment/treatment procedures, and document appropriate procedural information in the patient's medical record. ... diverse scope and complexity. Assists clinical team members and department or unit management in determining methods and procedures for new tasks. Assists with … more
- Merck & Co. (Rahway, NJ)
- …and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership and make ... introductions and technology transfers across the network.Drive proactive risk management activities, including risk assessment, risk mitigation, and risk… more
- Repligen (Waltham, MA)
- …supporting root cause investigations, and ensuring Repligen's supplier network meets regulatory and quality standards. This role is based in Waltham, MA, ... Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.Coordinate cross-functional teams to assess and mitigate risks… more
- Merck & Co. (North Wales, PA)
- …effectiveness to the business and communicate suggestions for improvement Document needs for customization or localization of learning programsReview ... in medical/legal/ compliance (CRT) reviews-Understanding of the US and Global regulatory stages and requirements-Job Owner - Fully responsible for asset … more
- Aequor (Thousand Oaks, CA)
- …onsite if systems go down and manual processes required. Experience with Quality Management Tracking Systems (QMTS) is preferred but not required - full training ... across functions, troubleshoot distribution issues, and ensure compliance with regulatory and quality standards. Key Responsibilities and Activities General: -… more
