- Bristol Myers Squibb (Princeton, NJ)
- …data analysis, interpretation, and reporting + Collaborates on cross-functional drug development teams, regulatory submissions, and departmental initiatives; ... The Director will play an active role in our drug discovery and development efforts to advance RayzeBio's (a...drug development (MIDD) approaches + Track record of regulatory interactions and deliverables, eg, IND, NDA, BLA and… more
- Pfizer (New York, NY)
- …Experience in pharmacometric analyses + Good communication skills (written, oral). + Drug development and/or regulatory experience + Publications in relevant ... ideas, and recognizes individual contribution. **ROLE SUMMARY:** + Develops model informed drug development (MIDD) plans across projects and disease areas in order… more
- Stony Brook University (Stony Brook, NY)
- …a minimum of three (3) professional references. + Successfully complete a 4 panel drug screen * + Meet Regulatory Requirements for pre employment screenings. + ... and timely reporting of patient results and compliance with all regulatory standards. Qualified candidates will demonstrate superior patient care and possess… more
- Bristol Myers Squibb (Madison, NJ)
- …+ Provides medical and scientific expertise to BMS colleagues in drug discovery, labeling, regulatory , outcomes research, and marketing/commercial departments ... organization dedicated to the effective design and execution of drug development. Clinical Development drives clinical development strategy, design, execution,… more
- Merck (North Wales, PA)
- …processes (SOPs) and software development life-cycle (SDLC) + US and/or worldwide drug or vaccine regulatory application submission experience including the ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck (Rahway, NJ)
- …include coordinating the activities of a programming team. + US and/or worldwide drug or vaccine regulatory application submission experience at the leadership ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Takeda Pharmaceuticals (Boston, MA)
- …stakeholders such as Clinical Operations, Clinical Biomarkers, Clinical Sciences, Oncology Drug Discovery and Regulatory Sciences to successfully deliver, ... diagnostics or IVD programs. + Have background in understanding of drug -diagnostic co-development and regulatory pathways. + Experience with biomarker-driven… more
- Pfizer (New York, NY)
- …and programming software (eg, Nonmem, R). + Experience in pharmacometric analyses + Drug development and/or regulatory experience + We encourage applicants from ... ideas, and recognizes individual contribution. **ROLE SUMMARY:** + Develops model informed drug development (MIDD) plans across projects and disease areas in order… more
- Stony Brook University (Stony Brook, NY)
- …a minimum of three (3) professional references. + Successfully complete a 4-panel drug screen * + Meet Regulatory Requirements for pre-employment screenings. + ... and timely reporting of patient results and compliance with all regulatory standards. Qualified candidates will demonstrate superior patient care and possess… more
- Takeda Pharmaceuticals (Lexington, MA)
- …role interacts with external CLO and CMO and vendors, works closely with drug product, quality, regulatory , program leadership, etc. and establish strategic ... scale-up a plus. + Proven track record of developing and gain regulatory approval of drug delivery systems a plus + Working knowledge of solid works desirable.… more