- Merck & Co. (Rahway, NJ)
- …for clinical supplies . - Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing...and senior leaders.- - Works directly in the SAP system to establish a consolidated , visible forecast for… more
- Eisai, Inc (Nutley, NJ)
- …will have the primary role of demand generation by conveying complex clinical information to customers and key stakeholders consistent with the FDA-approved ... demand generation within assigned geography by effectively conveying complex clinical information to customers and key stakeholders.Develop, maintain, and execute… more
- Eisai, Inc (Raleigh, NC)
- …applicable regulatory requirements (eg, FDA, EMA, ICH) and quality systems .Strong oral and written communication skills.Strong attention to detail and ability to ... profile, we want to hear from you. The QA Specialist plays a critical role in ensuring the quality...in ensuring the quality and compliance of commercial and clinical products manufactured at the Eisai Raleigh facility. This… more
- Aequor (Thousand Oaks, CA)
- …work alongside other innovative, driven professionals in this meaningful role. Role: Specialist Manufacturing, New Product Introduction Let's do this! At we strive ... for the introduction of new products into the manufacturing plant. This " Specialist Manufacturing" role will serve as a New Product Introduction Lead within… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …protocols, reports).Review and approve periodic review documentation for qualified equipment/ systems (audit trails, user groups, system administration)Provide ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Validation Specialist III as part of the Quality team based in Raritan, NJ. Role… more
- Merck & Co. (Rahway, NJ)
- …Experience with sterile GMP facility startup.Knowledge of Investigational drug regulatory requirements.Understanding of Clinical Supply Chain Operations.Current ... biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing facility in Rahway, New Jersey.The Sterile Process… more
- Eisai, Inc (Phoenix, AZ)
- …customer business, disease state, product prescribing information, approved promotional clinical trials, patient access to medication, and regulatory /compliance ... profile, we want to hear from you. The Senior Oncology Sales Specialist is responsible for meeting/exceeding sales goals through promoting Oncology therapeutic… more
- Beth Israel Lahey Health (Boston, MA)
- …a job, you're making a difference in people's lives.** The Regulatory Specialist supports regulatory compliance for clinical research at Beth Israel ... Excel, PowerPoint or Access. **Preferred Qualifications:** + 1-3 years of clinical trial regulatory affairs experience preferred. **Competencies:** **Written… more
- AdventHealth (Orlando, FL)
- …healthcare with visionary leadership and world-class resources. **The role you'll contribute:** Clinical Regulatory Specialist - Emergency Department (CRSED) ... Offers supports to staff. + Prioritizes, compiles, and maintains regulatory data as required for system initiatives...a RN program + Two years of recent ED clinical nursing experience + Basic Life Support (BLS) certification… more
- University of Pennsylvania (Philadelphia, PA)
- …of health and wellness programs and resources, and much more. Posted Job Title Clinical Research Regulatory Specialist B (Abramson Cancer Center) Job Profile ... Title Clinical Research Regulatory Specialist B Job Description Summary The...WebEx, BlueJeans etc. Knowledge and/or experience working with web-based e- regulatory document management systems such as eFlorence,… more
- University of Southern California (Los Angeles, CA)
- … SpecialistApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/ Clinical -Research- Regulatory - Specialist ... principal investigators and quality assurance systems for the Clinical Investigations Support Office. Provides regulatory affairs support, coordinating… more
- Corewell Health (Southfield, MI)
- This is a corporate position with primary work supporting Clinical Compliance, Accreditation and Regulatory Compliance at Corewell Health East Region. About ... believe health and well-being should be within reach for all. We believe the system to support the entire health and wellness journey starts with prevention. We… more
- WMCHealth (Valhalla, NY)
- …in accordance with established rules, procedures, specified time frames, and regulatory requirements. The Specialist processes clinical information ... Authorization Specialist Company: NorthEast Provider Solutions Inc. City/State: Valhalla,...Responsibilities: + Enters and retrieves information from various automated systems and prepares specializedreports. + Perform telephonic clinical… more
- Community Health Systems (Tucson, AZ)
- …ensuring compliance with healthcare regulations and standards. The Performance Improvement and Regulatory Specialist works closely with clinical , non- ... responsible for supporting the hospital's performance improvement (PI) and regulatory compliance programs. This role involves analyzing performance data, identifying… more
- Northern Light Health (South Portland, ME)
- …needing improvement at the staff, team, and agency level regarding outcome and regulatory compliance. The Clinical Assurance Specialist assists with ... clinical audits and utilizing the unusual occurrence reporting system to document any pertinent findings. The incumbent exercises...minimum 3 years required. Required Certifications: + Home Care Clinical Specialist - OASIS (HCS-O) - The… more
- Houston Methodist (Houston, TX)
- …and study specific protocols/plans and processes. The Regulatory Compliance Specialist position maintains documentation for clinical research studies, case ... At Houston Methodist, the Regulatory Compliance Specialist position is responsible...notifies IRB of study closures. + Maintains the required regulatory files for all clinical trials to… more
- Kelly Services (Valencia, CA)
- ** Regulatory Affairs Specialist - Valencia, CA** Kelly(R) Science & Clinical is seeking a Regulatory Specialist for a temporary, long-term position ... regulatory reviews, and participating in audits. The Regulatory Specialist will also act as a... submissions and performing audits. + Experience with QA systems : FDA, ISO 13485, MDR/MDD, MDSAP. + Self-starter with… more
- McLaren Health Care (Detroit, MI)
- Provide study coordinator/data management/ regulatory specialist support to the Clinical Trials Office (CTO). Manage independent assignment, providing ... excellent customer support and guidance in the clinical trials arena. **Responsibilities:** + Assure all studyrequirements are met and documented and meet both… more
- McLaren Health Care (Detroit, MI)
- Provide study coordinator/data management/ regulatory specialist support to the Clinical Trials Office (CTO). Manage independent assignment, providing ... excellent customer support and guidance in the clinical trials arena. **This position is onsite in Detroit,...a timely manner according to CTO SOPs. + Design systems for coordinating, compiling and submission of data; design… more
- Georgetown Univerisity (Washington, DC)
- …for Infectious Diseases Clinical Trials Unit will work with and assist the Clinical Research Coordinator, Regulatory Specialist , and Clinical Trial ... entering data into the clinical trial sponsor system , as well as internal software. They d evelop...The Data Analyst will work with and assist the Clinical Research Coordinator, Regulatory Specialist ,… more
