- Emory Healthcare/Emory University (Atlanta, GA)
- …+ The Regulatory Specialist III is an advanced level position supporting regulatory affairs in clinical trials research. + Employees in this ... of experience in clinical research, with a focus on regulatory affairs . + Knowledge: Strong knowledge of federal regulations, IRB processes, and relevant… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …statistical outputs. + Interpret statistical results; collaborate with cross-functional teams ( clinical operations, regulatory affairs , medical writing, data ... Management and Systems collaborating closely with MCA - Medical Affairs and Clinical Affairs -...regulatory guidelines. + Design statistical analysis plans for clinical studies and observational studies. + Lead the design… more
- J&J Family of Companies (Spring House, PA)
- …partnership with the Compound Development Team (CDTL) and project management, global regulatory affairs , clinical pharmacology, health economics, and the ... Mindset, Drug Discovery Development, Industry Analysis, Innovation, Market Research, Regulatory Affairs Management, Research Ethics, Scientific Evaluation,… more
- Rhythm Pharmaceuticals (Boston, MA)
- …strategy. The role requires extensive cross-functional engagement with senior leaders in clinical development, regulatory affairs , data sciences, and ... with corporate objectives. + Collaborate with senior leaders across clinical development, regulatory affairs , data sciences, and commercial to drive… more
- J&J Family of Companies (Irvine, CA)
- …collaborating with multiple cross-functional partners including Marketing, Medical Affairs , Clinical Teams, Regulatory Affairs , and Sales Leadership. ... n-BCA Liquid Embolic System and Enterprise Vascular Reconstruction Device with Clinical Affairs , Regulatory , and Legal teams. + Oversee development and… more
- AbbVie (North Chicago, IL)
- …to clinical development, quality assurance, technology, data management, and regulatory affairs . + Study Management Associate Organization: The Study ... with cross functional teams, including but not limited to data management, regulatory affairs , Clinical Site Management (CSM) and external partners to ensure… more
- Boehringer Ingelheim (Ridgefield, CT)
- …with all relevant internal global functions (eg Epidemiology, early and late-stage Clinical Development teams, Regulatory Affairs , Drug Safety, Marketing, ... product specific input to global Pharmacovigilance (PV) and global Regulatory Affairs (RA). + Develops and/or provides...internal conferences and committees. + Plans, writes and maintains Clinical and Regulatory documents such as: Medical… more
- Oracle (Lansing, MI)
- …and expand long-term relationships with senior-level stakeholders across Commercial, Medical Affairs , Clinical Development, Regulatory , and Safety ... professional to drive growth across **Commercial, Real-World Evidence (RWE), Clinical , Regulatory , and Safety research services** within pharmaceutical… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Collaborate and communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs , Quality Assurance, Medical ... Affairs , Marketing, Manufacturing, and Legal. + Interact with Regulatory Authorities as part of a cross-functional team to submit and defend regulatory … more
- Sanofi Group (Cambridge, MA)
- …strategy with the global project team and internal partners, such as clinical operations, translational medicine, regulatory affairs , biostatistics, drug ... SOPs, GCP, ICH guidelines and other regulations + Review documents supporting clinical development such as Investigator's brochure, regulatory documents for IND… more