- 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
- Fusion Medical Staffing (Morristown, NJ)
- …enjoying competitive pay, comprehensive benefits, and the support of a dedicated clinical team. Required Qualifications: One year of recent experience as a Telemetry ... administering treatments, and collaborating with healthcare teams to ensure high- quality , patient-centered care for individuals with cardiac conditions. The position… 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
- 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
- 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
- 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
- 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
- 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
- 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
- Deloitte (Morristown, NJ)
- Healthcare Clinical Documentation Specialist - Senior Consultant Our Deloitte Regulatory , Risk & Forensic team helps client leaders translate multifaceted risk ... include: + Operational Improvement: For business process that include significant clinical documentation and regulatory requirements, you will improve efficiency… more
- Sanofi Group (Morristown, NJ)
- …Clinical Operations (EDCO, including Clinical Trial Managers and Data Managers), Regulatory Affairs, Patients Safety & Pharmacovigilance, Therapeutic Area ... Clinical Operations (EDCO, including Clinical Trial Managers and Data Managers), Regulatory Affairs, Patients Safety & Pharmacovigilance, Therapeutic Area… more
- Bristol Myers Squibb (Madison, NJ)
- …* Ensures studies are aligned with target label indications and are designed to meet regulatory , quality , medical, and access goals * Serves as a matrix leader ... to proactively partner with these roles + Accountable for clinical content for CSRs, regulatory reports, briefing...following attributes: + Able to synthesize internal and external data to produce a clinical strategy +… more
- Bristol Myers Squibb (Madison, NJ)
- …of clinical studies including but not limited to + Protocol development + Clinical data review + Data interpretation; review and validation of CSRs ... provides the scientific expertise necessary to design and deliver clinical studies and programs with high quality ...elements + May serve as Trial Lead for complex clinical studies + May present data /information to… more
- Bristol Myers Squibb (Madison, NJ)
- …of clinical trials and will supervise and have accountability for the clinical components of regulatory filings + Will contribute to overall strategy for ... a clinical development leader; with greater than 10 years of extensive clinical trial, drug development, and regulatory experience, in addition to a strong… more
- Bristol Myers Squibb (Madison, NJ)
- …to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting ... reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality (collaboration with Medical Writing) +...CS team + Clinical data trend identification; provide trends and escalate questions to… more
