- Pfizer (New York, NY)
- …eg, Clinical Operations, Data Management, Safety, Biostatistics, Regulatory , Study Management, Pre- Clinical , Pharmacology, Quality Assurance. ... study results Support execution for all FIH programs through proof-of concept Set the clinical data review strategy, ensure quality data and conduct… more
- Canfield Scientific, Inc (Parsippany, NJ)
- …with the ability to multi-task and prioritize, and is driven to deliver high- quality , evidence-based insights that shape clinical research outcomes. The ideal ... Carry out literature reviews to support study design, outcome development, and clinical , commercial or regulatory activities Prepare, write, and review study… more
- SOFIE (Totowa, NJ)
- …new products from concept to reality-ensuring every process meets the highest standards of quality and regulatory compliance (21 CFR 211 and 212). If you're ... Responsibilities Develop protocols for the production and analysis of clinical -grade radiopharmaceuticals, validate these methodologies against quality … more
- SOFIE (Totowa, NJ)
- …Responsibilities Develop protocols for the production and analysis of clinical -grade radiopharmaceuticals, validate these methodologies against quality ... they will ensure that these radiopharmaceuticals are in full compliance with all regulatory requirements (specifically, 21 CFR 211 and 212). Essential Duties and… more
- RWJBarnabas Health (Oceanport, NJ)
- Quality Clinical and Regulatory Data Improvement CoordinatorReq #:0000221403 Category: Quality / Patient Safety Status:Full-Time Shift:Day ... is supporting department executive leadership in areas specific to clinical quality , patient safety events, regulatory...national benchmarking, NHSN, EPIC, Joint Commission resources and other clinical , payor or regulatory data … more
- Mount Sinai Health System (New York, NY)
- …sound manner. The CCTO is composed of regulatory , financial, clinical , study management, compliance, and data management personnel that support ... studies + 3+ years of direct experience in Regulatory Affairs, Clinical Affairs or Quality...related issues. + Able to read and understand scientific pre- clinical and clinical data applied… more
- J&J Family of Companies (Raritan, NJ)
- …improvement. + In-depth understanding of clinical development, quality and regulatory standards and policies relevant to data management and data ... to drive increased efficiency, quality , performance, and innovation within the Clinical Data Acquisition functional area promoting the overall efficiency of… more
- Mount Sinai Health System (New York, NY)
- …science, engineering, and clinical teams toward shared goals. 271 - DTP Clinical Data Science - MSH, Mount Sinai Hospital **Responsibilities** + **Identify ... regulatory and ethical standards, and integrate seamlessly into clinical workflows. **Qualifications** **Minimum Education** Bachelor's degree; Master's in… more
- WMCHealth (Valhalla, NY)
- …(IC) and Antimicrobial Stewardship (ASP) is responsible for maintaining and optimizing on-going data reporting for quality , regulatory and pay for ... Asst Dir, Clinical Optimization & Data Analytics Company:...multiple sources as it relates to IC and ASP quality metrics. To optimize clinical workflow, the… more
- Sanofi Group (Morristown, NJ)
- … regulatory authorities. You'll collaborate across R&D, Device, Manufacturing, and Quality teams while preparing high- quality regulatory submissions, ... relationships with Global Regulatory Affairs (GRA), Regional GRA, Country Regulatory Groups, Technical and Quality Groups within R&D and Manufacturing… more
- Reckitt (Parsippany, NJ)
- …Development, we're full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a ... regulatory staff and key stakeholders on the sales, marketing, R&D, quality and packaging engineering teams to manage regulatory and compliance approvals… more
- Terumo Medical Corporation (Somerset, NJ)
- …and applicable regulatory requirements, while driving continuous improvement in clinical quality systems and processes. Key responsibilities include planning ... Sr. Clinical Quality Specialist Date: Nov 19,...strategic input to clinical teams to ensure data integrity, regulatory compliance, and patient safety… more
- Sanofi Group (Morristown, NJ)
- …authorities including FDA and EMA. You'll collaborate across R&D, Manufacturing, and Quality teams while preparing high- quality regulatory submissions, ... Authorities **Manage CMC documentation and submissions** + Write, prepare, review, and approve regulatory CMC dossiers + Ensure dossiers meet quality standards +… more
- IQVIA (New York, NY)
- …Management Leads to oversee end-to-end data management delivery for global clinical trials. You'll ensure quality , accuracy, and compliance while leading ... **IQVIA is growing! Hiring multiple Clinical Data Management (CDM) Leads across...promote best practices. + Drive process improvements and ensure regulatory and SOP compliance. **Who We're Looking For** Ideal… more
- Sanofi Group (Morristown, NJ)
- …to get started? **Main Responsibilities** : + Enables the GRL by providing quality regulatory input and position to internal business partners, including but ... **Job Title:** Regulatory Strategist **Location:** Morristown, NJ/Cambridge, MA **About the...not limited to the clinical development teams, commercial and GRT for assigned projects.… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …relevant experience. + BA/BS with 10+ years' relevant experience. + Significant regulatory , quality , compliance or related experience in the biopharma industry. ... analytical abilities, as evidenced by strengths in assessing complex, multidisciplinary data , understanding and effectively advising on its regulatory … more
- Mount Sinai Health System (New York, NY)
- …individual interfaces directly with MSMC Departments, Administrators, Nursing, Medical and Quality Leadership, and Clinical Staff, managing the educational and ... - Oncology Administration - MSH, Mount Sinai Hospital **Responsibilities** 1. Oversees clinical operations within the program, using data and fact-based problem… more
- J&J Family of Companies (Raritan, NJ)
- …practices for architecting effective data solutions and frameworks that enable high quality data + Working knowledge of other Global Regulations like EU ... Description:** Johnson and Johnson is recruiting for an **Enterprise Quality R&D Clinical Computer System Validation (CSV)...Responsibilities:** + This role must ensure that all J&J quality standards and global regulatory requirements are… more
- Sanofi Group (Morristown, NJ)
- …teams trainings + Answer to medical questions raised by HA, EC/IRBs, sites + Ensure quality of clinical data through continuous data validation, blinded ... packages for regulatory meetings, PSP/PIP + Ensure clinical data meets all necessary regulatory...decision and status quo with a risk-management approach + Quality - focused, able to develop good practices, using a… more
- Mount Sinai Health System (New York, NY)
- …trends, patterns, and opportunities for improvement. + Knowledgeable of roles of regulatory and data benchmarking organizations, such as CMS, NHSN, NDNQI, ... **Job Description** The mission of the Patient Safety and Quality department within the Mount Sinai Institute of Critical Care Medicine (ICCM) is to enhance patient… more
