- Philips (Murrysville, PA)
- …Care team will lead a talented team in planning and executing clinical studies, ensuring regulatory compliance, process improvement, and impactful reporting ... + Acts as a subject matter expert on GCP, ISO, FDA, and global regulatory requirements, guiding best practices in clinical research, audits, and compliance. +… more
- University of Pennsylvania (Philadelphia, PA)
- …organizations. The Director will ensure that Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), regulatory guidelines, and all best practices ... organizations. The Director will ensure that Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), regulatory guidelines, and all best practices… more
- CommonSpirit Health at Home (Lexington, KY)
- …patient plans of care are appropriate and in compliance with all regulatory , operational, and financial requirements. + ** Clinical Record Compliance:** Assure ... the accuracy, completeness, and timeliness of all clinical records, meeting regulatory , operational, and financial requirements. + **EMR Workflow Completion:**… more
- Mount Sinai Health System (New York, NY)
- …interpersonal skills + Demonstrated knowledge of clinical research concepts, good clinical practices and regulatory compliance + Proven ability to provide ... **Job Description** As the Clinical Trials Manager, you will coordinate and manage...provides administrative oversight and guidance regarding staff roles and regulatory submissions for each study. This position reports into… more
- Ascendis Pharma (Palo Alto, CA)
- … regulatory strategy + Contribute to drafting and reviewing of clinical documents, manuscripts, presentations, and regulatory submissions + Maintain ... up-to-date knowledge of relevant science, medical information, good clinical practices, and regulatory guidance + Collaborate with-and serve as a clinical … more
- Lilly (Indianapolis, IN)
- …interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other ... May represent Lilly at key external meetings. + Responsible for understanding the regulatory requirements related to the clinical studies and global drug… more
- Amgen (Thousand Oaks, CA)
- …and mentoring of clinical development colleagues in co-authoring and reviewing clinical sections of regulatory documents + Lead the evidence generation ... is desirable + Solid understanding of relevant areas such as biostatistics, regulatory , clinical pharmacology, pre- clinical toxicology approaches + Knowledge… more
- The Cigna Group (Bloomfield, CT)
- …measurement/reporting into digitally acquired analytics, and generating insights that support clinical strategy and regulatory compliance. The role requires ... Analytics Sr. Manager oversees a team of analytics professionals focused on clinical quality measurement and insights. Works in collaboration with business leaders… more
- Bristol Myers Squibb (Brisbane, CA)
- …of clinical trials in collaboration with cross-functional teams (eg, Clinical Operations, Data Management, Regulatory Affairs). + Conduct literature reviews ... questions and resolve study-related issues. + Contribute to the preparation of clinical study reports, regulatory submissions, and responses to health authority… more
- J&J Family of Companies (Titusville, NJ)
- … studies, review and interpret clinical trial data, provide input into clinical study and regulatory communications and reports, and contribute to ... results. + Author, review, and/or provide strategic input into: + Clinical sections of regulatory documents including, IND submissions, annual updates,… more