- 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
- GRAIL (Trenton, NJ)
- …Qualifications:** + **Experience** + Minimum of 10 years of experience in regulatory , development, clinical affairs, quality , or program management ... and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to… 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
- Parexel (Trenton, NJ)
- …with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of ... manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or… more
- Parexel (Trenton, NJ)
- …with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of ... manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or… more
- Parexel (Trenton, NJ)
- …+ When required Partners with other Study Team members (eg Clinician, Recruitment Specialist, Clinical Data Scientist) + May act as a Mentor for Clinical ... + Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators + Drive Quality Event (QE) remediation,… 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
- Parexel (Trenton, NJ)
- …the case processing cycle + Provide input as necessary to Feasibility Studies, Data Monitoring Committees (DMCs), Clinical Endpoint Committees (CECs) + Provide ... complex safety evaluations that directly impact patient wellbeing and regulatory compliance. **About the Role** As a **Senior Physician...attention to detail + An ability to assess the clinical relevance of medical data and to… 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
- Parexel (Trenton, NJ)
- …team distribution or shipment to client. + Provide technical leadership to ensure clinical data presented in summary documents is in compliance with applicable ... + Manage ongoing and/or revised project documentation and correspondence. ** Quality Control** + Ensure that all work is complete...+ Broad experience in preparation of all types of clinical regulatory documentation. Experience in management of… 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
- Parexel (Trenton, NJ)
- …review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but ... analysis plans and mock statistical output to determine appropriateness of content/format for clinical writing. ** Quality Control** + Ensure that all work is… more
- Parexel (Trenton, NJ)
- …work remotely. The Principal Biostatistician works independently on all level complexity clinical trial projects, often with major regulatory impact. The person ... papers based on current good statistical practice + Interact with clients and regulatory authorities + Review publications and clinical study reports + Travel… more
- Parexel (Trenton, NJ)
- …issues, and collaborates with various functions to optimize communication, maintain site quality and patient safety utilizing data analytics to identify and ... ICH-GCPs, and other applicable requirements **Skills:** + Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements +… more
- Terumo Medical Corporation (Somerset, NJ)
- …world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is ... SAP and Cloud security policies, procedures, and configurations to protect sensitive access, data and comply with various regulatory requirements (eg GxP, JSOX,… more
- Hackensack Meridian Health (North Bergen, NJ)
- …Builds the infrastructure to facilitate lifelong learning. Analyzes competency assessment data to identify gaps in practice. Develops educational programs to achieve ... varying abilities into workforce planning. Prepares staff to transition across clinical settings. Manages the practice gaps between academia and service. Creates… 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
- Hackensack Meridian Health (Clark, NJ)
- …Center is a new state of the art medical facility that will provide high quality , convenient and easy access to all patient's health and wellness services under one ... HMH is seeking customer service oriented individuals to provide clinical and administrative care and to create the best...medical monitoring and splinting. Collects and records patient care data that follows format and guidelines of the patient… more
- Terumo Medical Corporation (Somerset, NJ)
- …world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is ... Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of applications for… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …as managed care providers. Our goal is to continue to develop and market quality products that bring value to our customers and ultimately the patient. Current ... performance evaluations. + Cross-functional Collaboration: Partner with Medical Affairs, Clinical Development, Compliance, and Commercial teams to ensure training… more
