- TechOp Solutions International (Arlington, VA)
- …years of experience in research compliance, clinical or behavioral research , public health, or regulatory affairs . *Strong understanding of human ... reports, briefings, and stakeholder communications. *Monitor and document human research protections issues, regulatory risks, and training requirements… more
- Tulane University Staff (New Orleans, LA)
- …of Clinical Research Associates or SoCRA) is strongly desired. * Regulatory Affairs Certification (RAC), Certified Clinical Research Coordinator ... The Clinical research Project Manager is responsible...clinical trial conduct at the TRIAD Center including regulatory compliance, patient safety, data quality and personnel management.… more
- Cytokinetics (South San Francisco, CA)
- … Team for an assigned program and work cross-functionally with Clinical Research , Drug Safety, Biometrics, Quality, Medical Affairs , and others to advance ... is seeking an experienced and highly motivated Senior Director, Regulatory Affairs to join the Global ...be responsible for developing, implementing and advising on global regulatory strategies for clinical stage programs to… more
- University of Kansas Medical Center (Kansas City, KS)
- …(CFR, GCP, HIPAA). Experience with statutes and guidelines relevant to regulatory affairs in clinical research . Experience study budgets, contracts, and ... Department: SOM KC Cancer Center Clinical Trials Administration Position Title: Clinical Research Coordinator - Cancer Center Job Family Group: Professional… more
- Abbott (Santa Clara, CA)
- …experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs , operations, or related area. ... and software, vessel closure devices and peripheral stents. This Regulatory Affairs Manager position is an onsite... regulatory strategy and update strategy based upon regulatory changes Support pre and post approval clinical… more
- Katalyst HealthCares and Life Sciences (Boston, MA)
- …3 days per week) based in Marlborough, MA. Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and ... in a scientific, technical, or related discipline. A minimum of 8 years Regulatory Affairs experience in the medical industry. Prior experience of supporting… more
- Kura Oncology (Boston, MA)
- …all behaviors, decisions, and actions. ESSENTIAL JOB FUNCTIONS: The Assoc Dir/Director, Regulatory Affairs will be responsible for developing, implementing, and ... and technical regulatory input for key product development documents. Perform regulatory research and intelligence to continually inform project teams of the… more
- BioSpace (New York, NY)
- …and mentor talent within the organization. Cross-functional Collaboration: Work closely with clinical development, regulatory affairs , market access, and ... as the Vice President and Head of Global Medical Affairs . This role will serve as a strategic thought...MS Office Suite and familiarity with tools used in clinical trial design or health outcomes research … more
- BlueRock Therapeutics (Cambridge, MA)
- …internal team engagement and strong external partnerships. Work with Regulatory Affairs to design and implement any post-approval clinical studies (including ... to the Head of Development, the Head of Medical Affairs will have the unique opportunity to build a...ex-US experience is helpful. Experience or demonstrated understanding of clinical development and research Direct interactions or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …RWE Epidemiology Legal and compliance Marketing/ commercial GMP QA/ Supply chain / Regulatory Affairs Leadership/ team management: Create a high performing team ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. JOB SUMMARY The… more
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