- Formation Bio (New York, NY)
- …of Quality Assurance are to develop and implement a comprehensive quality assurance strategy that ensures compliance with regulatory requirements and ... appropriate identification, evaluation, and management of risks associated with product quality . Build strong relationships with regulatory agencies and other… 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
- 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
- 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
- Organon & Co. (Jersey City, NJ)
- …Director will work collaboratively with cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs, chemistry, ... the scientific and data integrity, rigor and quality thereof. The director may represent the Clinical...regulatory standards. + Ability to understand and interpret clinical and scientific information and data and… more
- Inizio Engage (New York, NY)
- …(AE) and product complaint reporting On-label and compliant promotional dialogue CRM data quality and timely documentation Maintain alignment with corporate ... a launch environment and who want their work to have genuine clinical impact. Key Responsibilities Strategic Territory Development Design and execute territory… more
- Memorial Sloan-Kettering Cancer Center (New York, NY)
- …Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our understanding of ... functions, activities, and operations of assigned departments to provide high quality , efficient, and cost-effective patient care and ensure compliance with… more
- FleishmanHillard (New York, NY)
- …to meet deadlines and manage multiple projects simultaneously. + Ability to communicate clinical data and information into lay language that resonates across ... media, third-party organizations, healthcare professionals and consumers. Influencer campaigns, data milestones, product launches, medical congresses, patient storytelling, awareness… more
- Organon & Co. (Jersey City, NJ)
- …field. + Five years of industry experience? in R&D functions (eg, Clinical Research, Early Development, Medical Affairs, Pharmacovigilance, Regulatory Affairs, ... program information in reports and systems to enable high quality portfolio communications. + Contribute to and facilitate an...and leadership. + Seek internal and external information and data points to inform best practices and options. +… 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
- 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
- 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
- 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
- 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
- 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
- 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
