- Novo Nordisk Inc. (Plainsboro, NJ)
- …preparation of periodic and annual reports for submission to the FDA Monitor the quality of Product patient Safety deliverables and provide ongoing feedback ... and support the evaluation of daily GXP lists for regulatory submission of individual case safety reports... Quality Management Review (QMR) reporting content for Patient Safety and Global Safety … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of patient support program data, including data sources, data quality , data governance, and data privacy considerations Establish and maintain data governance ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Eisai, Inc (Nutley, NJ)
- …and assures compliance with standard operating procedures, compliance with regulatory standards and guidelines, and compliance with operating agreements with ... for and assures follow up of adverse event reports that potentially impact the safety profile of product area responsibility. Interacts with staff at other Eisai and… more
- Catalent (Philadelphia, PA)
- …facilities. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient , consumer, ... Protocols (as required). Audit for compliance as pertains to Catalent SOPs, regulatory , and customer requirementsSupport Corporate and local Quality policies and… more
- Tris Pharma (Monmouth Junction, NJ)
- …with counterparts/teams in Clinical Development, Regulatory Affairs, Manufacturing, Quality , etc. to identify, evaluate and communicate safety observations. ... updates, potential risks mitigation, etc. Collaborates with appropriate clinical, medical, quality and regulatory counterparts and others across business to… more
- Catalent (Philadelphia, PA)
- …facilities. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient , consumer, ... Quality Assurance Document Control Supervisor Position Summary Catalent...They will have a deep understanding and values around patient and employee safety , will assist in… more
- Catalent (St. Petersburg, FL)
- …lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient , consumer ... and prospective suppliers in compliance with Global procedures and Regulatory requirements Generate Global Quality Agreements in...a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to make a difference? The Position Drives the understanding & delivery of quality clinical research ( patient safety , rights & wellbeing; data ... us all marching to the same beat is our patient -centered focus. At Novo Nordisk, you will help patients...to protocol amendments, site staff and location changes and IRB/REB/ regulatory approvals to assure quality of the… more
- 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 ... and leadership for the investigations management system. Working closely with the Quality Senior Manager, this position will ensure alignment with all applicable… more
- Novo Nordisk Inc. (Phoenix, AZ)
- …ready to make a difference? The Position Drives the understanding and delivery of quality clinical research ( patient safety , rights and wellbeing; data ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...us all marching to the same beat is our patient -centered focus. At Novo Nordisk, you will help patients… more
- Merck & Co. (Rahway, NJ)
- …ensure:Data generated at site are complete, accurate and unbiasedSubjects' right, safety and well-being are protectedConducts site visits including but not limited ... appropriately in a timely manner.-Collects, reviews, and monitors required regulatory documentation for study start-up, study-maintenance and study close-out.Communicates… more
- Merck & Co. (Rahway, NJ)
- …Data generated at site are complete, accurate and unbiasedo Subjects' right, safety and well-being are protectedConducts site visits including but not limited to ... appropriately in a timely manner.Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or problems with projects and/or identification of issues which may compromise patient dosing or safety . Basic understanding of professional working environment ... as well as Quality Assurance and global regulatory requirements such...ongoing study support. Identifies critical issues which may compromise patient dosing or safety . Supports comparator sourcing… more
- Merck & Co. (Rahway, NJ)
- …guidelines, and quality standards, including cGMP, FDA, and other regulatory requirements. Safety and Environment: Prioritize and maintain a safe work ... emerging trends in small and large molecule/hybrid modalities and designing corresponding patient centric drug products through Phase 3 clinical development and line… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …studies: Provides the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and protocol compliance ... indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical… more
- Catalent (St. Petersburg, FL)
- …challenges.Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient , ... Catalent employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management support within Catalent's St. Petersburg site. The… more
- Catalent (Harman, WV)
- …satisfaction.Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient , ... regulatory SOP and cGMP guidelines.Manages processes to optimize quality performance and on-time delivery to insure customer satisfaction.Establishes annual… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of evidence generation, design and leadership of clinical development plans, and addressing all regulatory , drug and patient safety , data, CMC, IP, ... overarching and competitive, asset strategy and execution to ultimately achieve global regulatory filings and ensure wide access of the compound. That strategy will… more
- Catalent (St. Petersburg, FL)
- …activities in support of client regulatory filings.Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the ... safety of every patient , consumer and Catalent employee.The RoleAnalysis of finished products,...a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and… more
- Tris Pharma (Monmouth Junction, NJ)
- …internal departments (Research and Development (R&D), Supply Chain, Marketing, QA, Quality Control (QC), Regulatory , Packaging, project teams, etc.); ... a focus on development and commercialization of innovative medicines addressing unmet patient needs. We have more than 150 US and International patents (including… more
