- HSS (New York, NY)
- …too can be part of our transformation across the enterprise Administrative Director - Clinical Review Panels (CRPs Full-Time Overview: The primary responsibility ... of theAdministrative Director of the Clinical Review Panels (CRPs)is...Departments/Divisions that review and approve research projects prior to submission to the Institutional Review Board (IRB). This position… more
- Hackensack Meridian Health (Edison, NJ)
- …to transform healthcare and serve as a leader of positive change. The ** Director , Member Scientist, Clinical Research** is responsible for initiating, leading ... to national grant opportunities including but not limited to submission of the TBI Model Systems application and related...injury. **Responsibilities** A day in the life of a ** Director , Member Scientist, Clinical Research** at Hackensack… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Director Clinical Development - Respiratory Date: Aug 31, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 57466 ... be based in Parsippany, NJ or West Chester, PA Director , Clinical Development is responsible for the...and other regulatory documents + May lead an NDA submission team independently, as needed + Partners cross-functionally with… more
- Adecco US, Inc. (New Brunswick, NJ)
- …updates to senior management. + Ensure the integrity and quality of clinical data through rigorous oversight and quality control measures. **Qualifications:** ... ** Director of Clinical Research** **Adecco Healthcare...clinical research projects. + Oversee the preparation and submission of regulatory documents. + Develop and maintain relationships… more
- Bristol Myers Squibb (Summit, NJ)
- …Articulating clinical development strategy + Analyzing, interpreting, and acting on clinical trial data to support development + Serving as principal ... clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling… more
- AbbVie (Florham Park, NJ)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director , Clinical Pharmacology (Neuroscience) communicates/presents key Clinical ... scientific reports for regulatory filings and anticipates regulatory questions. Leads CLINICAL PHARMACOLOGY regulatory documents writing, submission and response… more
- AbbVie (Madison, NJ)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description As a Director within the Clinical Pharmacology Neuroscience Group at AbbVie, you ... scientific reports for regulatory filings and anticipates regulatory questions. Leads CLINICAL PHARMACOLOGY regulatory documents writing, submission and response… more
- Bristol Myers Squibb (Madison, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . ** Director , Medical Safety Assessment Physician (Immunology)** **Functional Area Description** ... review documents as well as safety sections of relevant clinical trial documents and regulatory filings. . Lead team...the evaluation & management of signals emerging from any data source. Develop strategy for signal evaluation and document… more
- AbbVie (Madison, NJ)
- …clinical development projects. A highly empowered, visible and collaborative role, the Director works in partnership with clinical and regulatory experts to ... managers, prior experience of people management is required. Key Stakeholders + Clinical Development experts + Statistical Programmers + Data Science experts… more
- Project Renewal, Inc. (Bronx, NY)
- …facility are clean and conform to established standards. + In collaboration with the Clinical Director , determines policy for the clinical programs. Ensures ... Program Director Shelter- Ana's Place, 4380 Bronx Blvd, Bronx,...of weekly, monthly or annual reports. + Ensures timely submission of supporting documents to respond to federal, state… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …US, EU and Japan as needed. + Assemble, evaluate, interpret, and present complex scientific clinical data as required for senior management on a global basis. + ... Director , MSLS will be responsible for MSLS strategy, clinical program oversight, and support of clinical ...(SAPs). + Oversee planning and support operational aspects of clinical trial execution, data management and … more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …in US, EU and Japan as needed. + Evaluate, interpret, and present complex scientific clinical data as required for senior management on a global basis. + Support ... As a senior member of Medical Science, the Senior Director , Medical Science - Early Stage will lead the...GDO. + Support flawless implementation and operational aspects of clinical trial execution, data management and … more
- Teva Pharmaceuticals (Parsippany, NJ)
- …in an E2E business model. As per business needs, may write and edit clinical regulatory documents, including submission summaries and other complex documents. as ... Director , Therapy Area Head, Global Regulatory Medical Writing...in the strategic planning, scope determination, and development of clinical and regulatory documents used in drug development and… more
- The Mount Sinai Health System (New York, NY)
- …International Center for Health Outcomes and Innovation Research (InCHOIR) is a clinical and data coordinating center with an interdisciplinary faculty. InCHOIR ... regulatory approval and management, endpoint and event adjudication and Data Safety and Monitoring Board management. In addition, faculty...programs as defined and agreed upon with the Senior Director of the Clinical Trial Operations and… more
- Merck (Rahway, NJ)
- …coordinating statistical activities supporting drug/vaccine projects. + Interacts with Clinical , Regulatory, Statistical Programming, Data Management, and our ... statistics in meetings with investigators and regulatory agencies in discussions about clinical trial issues and submission strategies. + Ensures the statistical… more
- Pfizer (New York, NY)
- …types by maintaining 'quality' line-of-sight for assets/protocols within the Pfizer Oncology clinical portfolio. + With this focus, the Asset Quality Lead (AQL) role ... knowledge of Level One quality issues and risk areas within assets and across clinical trial programs. In partnership with the appropriate roles in Clinical … more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …PV Agreements, Distributors, Solicited Programs, operational support of clinical studies, audit and inspection readiness/support, training, ICSR excellence, ... experienced individual to join the **PS Strategic Operations** team as a ** Director , PS Medical Device Safety** responsible for developing and leading implementation… more
- Bristol Myers Squibb (Madison, NJ)
- …regulatory risk, and developing global filing strategies. + Co-lead marketing application submission teams for indications that are at regulatory filing stage to ... liaison input. In collaboration with the Global Regulatory sub-team, develop global submission plans and HA interaction plans. + Provide input into the development… more
- Pfizer (New York, NY)
- …Health Technology Assessment (HTA) submissions; and projects to maximize the value of aggregate clinical and real world data in support of drug development and ... projects. + Provide planning, delivery, and communication of statistical analyses, data presentations, and scientific reports, including clinical trial results,… more
- The Mount Sinai Health System (New York, NY)
- …aspects of clinical research trial(s). Under guidance of the Associate Director of Research and Quality Outcomes, the CRA is responsible for collecting, ... The CRA also collects, maintains and organizes study information. **RESPONSIBILITIES** ** Clinical Events Committee (CEC) and Data Safety Monitoring Board… more