- Merck & Co. (Rahway, NJ)
- …to patients. The key areas of focus include: (1) diversity in clinical trials , (2) clinical trial recruitment and (3) general education and awareness ... globe, timely completion of carefully designed clinical trials is critical to drug development.The Specialist ,...(Internal and External) critical communications, focused on our global Clinical Trial efforts.This role is responsible for… more
- Merck & Co. (North Wales, PA)
- …and new indications for existing products. We ensure we conduct high-quality clinical trials by integrating state-of-the-art technology and applying rigorous ... additional standards library componentsParticipate in standards data governance reviewsThe Global Clinical Data Standards (GCDS) Data Standards Specialist may… more
- Merck & Co. (Rahway, NJ)
- …teamsThe Vocabulary Specialist maintains knowledge of new technologies, clinical study data standards, regulatory requirements emerging in industry, ... team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …of improving the health of our communities. About the Role:Job SummaryThe Research Regulatory Specialist performs a wide range of tasks essential to the ... submission, approval, and maintenance of required regulatory documents for conducting clinical research in...of high quality research within the department. Familiarity with clinical trials operations, finance, budgets, contracting and… more
- Piper Companies (Philadelphia, PA)
- …stage regulatory submissions to the FDA Maintains active IND and Clinical Trial applications.Experience submitted to the Center for Biologics Evaluation and ... Piper Companies is currently seeking a Regulatory Affairs Specialist , Cell & Gene Therapy for an opportunity in Philadelphia, Pennsylvania (PA), to join an… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …inspection/release of materials related to manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP ... of multiple myeloma. Legend Biotech is seeking a QA Warehouse Incoming Raw Material Specialist as part of the Quality team based in Raritan, NJ. Role Overview The… more
- Aequor (San Diego, CA)
- …complex medical-scientific data from a broad range of disciplines (eg, clinical trial laboratory data, nonclinical data, postmarketing reports, scientific ... of certain post-marketing commitments and ensuring compliance with global regulatory requirements.Position Summary / ObjectiveAppropriately perform core signal detection… more
- Catalent (Manassas, VA)
- …health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion ... to help create engaging new products consumers will love.The Document Control Specialist - 2nd Shift is responsible for creating and maintaining the Quality… more
- Option Care Health (Tallahassee, FL)
- …infusion services for a broad range of specialized therapies, as well as clinical trial services and special programs for pharmaceutical manufacturers. Joining ... reports directly to the Senior Manager of Quality, Regulatory and Education. The RN Quality Specialist ...is accountable and responsible for maintaining compliance of all clinical documentation processes. The RN specialist evaluates… more
- Stanford University (Stanford, CA)
- Clinical Trials Regulatory Specialist 2 **School of Medicine, Stanford, California, United States** Research Post Date Feb 16, 2024 Requisition # 100464 ... innovative clinical research to improve human health. SCCR seeks a mission-driven Clinical Trials Regulatory Specialist 2. You will work with a… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …the diversity and excellence of our academic community. **Description** JOB DESCRIPTION: + The Clinical Trials Regulatory Specialist I is an entry-level ... position supporting regulatory affairs in clinical trial research. + The primary focus... trial portfolio. + Duties include: + Assists regulatory team ( Regulatory Specialist II… more
- Emory Healthcare/Emory University (Decatur, GA)
- …The Regulatory Specialist II is an intermediate level position supporting regulatory affairs in clinical trial research. + Incumbents are responsible ... reports. + Establishes and maintains processes and monitors practices to ensure regulatory documentation involving clinical trials complies with… more
- Methodist Health System (Dallas, TX)
- … clinical , investigator initiated trials (IITs), and retrospective analysis of clinical data. The Regulatory Specialist will support the mission, ... requirements * Obtain and facilitate tracking of relevant regulatory documents for clinical trials ...trials assigned. * Assist in the development of clinical trial documents for signature of principal… more
- University of Pennsylvania (Philadelphia, PA)
- …Title Veeva Quality Assurance Specialist (Abramson Cancer Center) Job Profile Title Clinical Research Regulatory Specialist B Job Description Summary The ... is a world leader in developing and conducting innovative clinical trials for the prevention, diagnosis, and...CRU Regulatory Affairs Office seeks a full-time Regulatory Affairs Veeva Quality Assurance Specialist to… more
- Houston Methodist (Houston, TX)
- …event reports, safety reports, and notifies IRB of study closures. + Maintains the required regulatory files for all clinical trials to ensure regulatory ... and study specific protocols/plans and processes. The Regulatory Compliance Specialist position maintains documentation for clinical research studies, case… more
- Hackensack Meridian Health (Neptune, NJ)
- …Minimum of 2 years experience in a Senior Clinical Data Coordinator or Senior Regulatory Specialist role, or at least 4 years related experience in the field ... for coordinating and overseeing clinical operations of all assigned clinical trials and participates in assessing, planning, implementing and compliant… more
- Merck (Rahway, NJ)
- …to patients. The key areas of focus include: (1) diversity in clinical trials , (2) clinical trial recruitment and (3) general education and awareness ... globe, timely completion of carefully designed clinical trials is critical to drug development. The Specialist...nternal and External) critical communications, focused on our global Clinical Trial efforts. **This role is responsible… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The Senior Associate Director, Clinical Trial Diversity supports the Clinical Development & Operations (CD&O) strategy for Diversity & ... Inclusion in clinical trials , focusing on the US. They...the development and execution of Diversity & Inclusion in clinical trial strategies, core processes and best… more
- Vitalief (New Brunswick, NJ)
- …activation; regulatory compliance, data management. and other clinical trial activities for solid tumor, high enrollment, ... Join us and help clients adapt to evolving requirements in the research and clinical trial industry with cutting-edge solutions. Reasons to Work for Vitalief: +… more
- University of Colorado (Aurora, CO)
- …Team (CReST) has an opening for a full-time Clinical Research Startup Specialist to provide regulatory and operationalization startup support for a variety ... communicates with these entities in order to operationalize complex clinical trials . + Develops standard operating procedures... Clinical Practice, applicable regulations, and of the clinical trial lifecycle is essential. We are… more
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