- Sumitomo Pharma (Lincoln, NE)
- …products, ensuring continuous benefit-risk assessment. + Collaborate with colleagues in Clinical Development, Regulatory Affairs , Biostatistics, Data ... Investigator Brochures (IBs), informed consent forms (ICFs), protocols, study reports, regulatory reports, and regulatory responses. + Contribute to signal… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …at Global Clinical sub-teams. + Interact with Medical Directors, Clinical Scientists, Regulatory Affairs , Preclinical scientists, Statistical ... This position is for a qualified statistician/biostatistician to support Clinical Biostatistics with Global Development. **In this role, a typical day might… more
- Cordis (Miami Lakes, FL)
- …+ Act as the lead for scientific communications within cross-functional teams ( Clinical , Medical Affairs , Regulatory , Commercial), ensuring alignment and ... narratives from complex data for diverse audiences (eg, KOLs, regulatory bodies). + Expert in analyzing complex clinical...+ 8+ years of experience in scientific communications, medical affairs , medical writing, or clinical marketing within… more
- Cognizant (Austin, TX)
- …challenges, recommend solutions, and guide successful execution across areas such as Clinical Operations, Regulatory Affairs , Pharmacovigilance, and Quality. ... life sciences industry, with significant exposure to one or more functions: Clinical Development, Regulatory Affairs , Pharmacovigilance, Quality, or… more
- Sanofi Group (Swiftwater, PA)
- …+ Collaborates with colleagues mainly from PSPV as well as Pre- Clinical & Clinical Development, Regulatory Affairs , Medical Affairs , Legal and Global ... lifecycle of a broad range of marketed products and innovative therapies in clinical development. We are an innovative global healthcare company with one purpose: to… more
- J&J Family of Companies (Titusville, NJ)
- …quality monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs , data management, medical writing, biostatistics, global medical ... trial materials, and takes ownership for the content of clinical study reports and relevant documents for regulatory...(pre and post-marketing) for relationship to treatment + Assists Regulatory Affairs in determining requirements for any… more
- AbbVie (North Chicago, IL)
- …(eg, product safety team physicians, epidemiologists, safety analysts), Statistical Programming, Clinical Statistics, Regulatory Affairs , and Medical ... + Provide strategic input on safety related submissions to regulatory agencies and responses to requests from regulatory... regulatory agencies and responses to requests from regulatory agencies. + Attend regulatory meetings. +… more
- Johns Hopkins University (Baltimore, MD)
- …contractual process and financial management of clinical trials. + Experience in clinical research and regulatory affairs . + Experience in protocol and ... multi-centered clinical trial. + Develop standard operating procedures for regulatory submissions as needed. + Maintain a continued high level of expertise… more
- J&J Family of Companies (Titusville, NJ)
- …quality monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs , data management, medical writing, biostatistics, global medical ... team in responding to medical and compound-related issues + Working with Regulatory Affairs and global clinical operations to respond to questions from… more
- Takeda Pharmaceuticals (Lexington, MA)
- …program management experienced in leading cross-functional clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other drug ... phases of development with significant experience within related functions (eg, Medical Affairs , Clinical Operations, Regulatory , CMC, Marketing). + Minimum… more