- Pfizer (Groton, CT)
- …and regulatory activities including product labels, core data sheets, Investigator Brochures, Development Safety Update Reports, and Periodic Benefit-Risk ... clinical trial data. + Review and approve submission level safety narrative plan. + Supports product label...submission level safety narrative plan. + Supports product label development and maintenance. + Engage key external… more
- Taiho Oncology (Princeton, NJ)
- …Sheets, + Investigator Brochures, clinical summary of the NDA/MAA and product labeling and other applicable documents for clinical trials. + Evaluate current ... our team, you'll have the opportunity to shape the future of drug safety , contribute to groundbreaking research, and advance patient care worldwide. With competitive… more
- Amgen (Thousand Oaks, CA)
- …The position will work closely with all members of the cross-functional product team to apply full clinical knowledge to successfully advance clinical programs, ... as well as the overall product strategy. The Executive Director will report into the...of the primary and secondary endpoints for efficacy and safety as well as contribute to the biostatistics analysis… more
- Lilly (Indianapolis, IN)
- …Early Phase / Clinical Pharmacology, and Translational Medicine teams in new product development activities over the entire spectrum of drug development and clinical ... the reporting of adverse events as mandated by corporate patient safety ; review process for protocols, study reports, publications and data dissemination… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …Participate in the Protocol Approval Committee + Serve as a member of the Safety Review Board + Work seamlessly with Clinical Operations + Consult with commercial, ... leaders to determine needs and requirements for clinical research Expansion of Product Pipeline and Portfolio + Participate in the development of the strategic… more
- Kelly Services (South San Francisco, CA)
- …ECG, and concomitant medications; and maintain a medical decision log. + Represent safety during Site Initiation Visits, Investigator Meetings, CROs ,and other ... CRO and our client. + Accountable for medical evaluation/interpretation of aggregate safety data of assignment product (s) including signal detection and… more
- Houston Methodist (The Woodlands, TX)
- …sentinel events and serves as physician champion in PI efforts related to Patient Safety . Serves as the primary investigator for Medical Staff interviews for ... for excellence in clinical quality outcomes, value, and patient safety . The CQO position collaborates with the System CQO...consensus and garnering highest confidence in professionalism and work product by senior leadership + Ability to work under… more
- J&J Family of Companies (Horsham, PA)
- … Product Portfolio Management, Report Writing, Research and Development, Safety -Oriented, SAP Product Lifecycle Management, Statistics, Technical Credibility, ... for humanity. Learn more at https://www.jnj.com **Job Function:** R&D Product Development **Job Sub** **Function:** R&D Digital **Job Category:**… more
- Mount Sinai Health System (Brooklyn, NY)
- …in the selection of supplies, technology and equipment 3. Assure appropriate product utility while maintaining optimal patient safety and outcomes; identifies ... inpatients and out-patients on complex wound and ostomy cases. **Quality and Safety ** 1. Designs, supports and leads a safe, therapeutic and efficient… more
- J&J Family of Companies (Raritan, NJ)
- …the execution of medical affairs strategy for the clinical-commercial optimization of product development and life cycle management. The current role focuses on ... cross functional and cross regional stakeholders including the Regional Medical TA/ product leaders, global commercial and market access leaders, Clinical Development… more