- 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
- 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
- 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
- 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
- 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
- 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
- Northwell Health (Manhasset, NY)
- …health system. Job Responsibility + Provides strategic advice and guidance to the Clinical Quality Management & Performance Improvement functions. + Advises and ... and public reporting as required. Maintains current knowledge of regulatory agency requirements pertaining to Quality Management/Performance Improvement… 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
- Bristol Myers Squibb (Madison, NJ)
- …including Protocol Review Committee, support of Business Development activities and Quality and compliance leadership. The Clinical Trial Physician sits ... of clinical trials and will supervise and have accountability for the clinical components of regulatory filings. * Will contribute to overall Therapeutic… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …aggregated data during clinical trial conduct to identify trends and ensure quality data for database locks and interim cuts. + Serves as the primary ... you'll spend your day** + Designs, conducts, and reports clinical trials in line with the development, regulatory...clinical trial conduct, assessing study population, protocol adherence, data trends, safety data , adverse events (AEs),… more
- Pfizer (New York, NY)
- …Safety, Biostatistics, Regulatory , Study Management, Pre- clinical , Pharmacology, Quality Assurance. + Experience working on large data sets. + ... and contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other...the team in the collection of quality data and review of emerging clinical … more
- Sanofi Group (Morristown, NJ)
- …the medical expert in the Clinical Study team, ensuring the medical relevance of the clinical data and able to act as mentor for other clinical team ... agency interactions + Develop or contribute to the regulatory documentation for the project(s), provide clinical ...data within the scope of the centralized monitoring, clinical and medical information for the study team, medical… more
- Mount Sinai Health System (New York, NY)
- …implements best practices in clinical trial management, monitoring, vendor oversight, data quality , and regulatory compliance across multiple studies. ... trials within the Center for Interventional Cardiovascular Research & Clinical Trials. This role ensures high- quality , efficient...management, and remediation where needed to support enrollment and data quality goals. ** Regulatory &… more
- Mount Sinai Health System (New York, NY)
- …to study management. + Develop and implement best practices to enhance efficiency, data quality , and compliance. + Monitor industry trends and integrate ... Prioritize resources and allocate tasks to ensure timelines and objectives are met. ** Regulatory Compliance and Quality Assurance:** + Ensure all trials adhere… more
