- Sanofi Group (Morristown, NJ)
- …**About You** **Knowledge:** + Sound understanding of and experience with global regulatory requirements for combination products and drug delivery systems. + ... experience in the global healthcare industry. + Proven experience in drug /device combination product regulatory approvals. + Demonstrate strategic thinking,… more
- Bristol Myers Squibb (Princeton, NJ)
- …data analysis, interpretation, and reporting + Collaborates on cross-functional drug development teams, regulatory submissions, and departmental initiatives; ... and model informed drug development (MIDD) approaches + Track record of regulatory interactions and deliverables, eg, IND, NDA, BLA and MAA filings. + In-depth… more
- Pfizer (Collegeville, PA)
- …pharmaceutical medicine including clinical trial design, GCP and data interpretation, drug development, regulatory and promotional rules/guidance, legal and ... appropriate for a variety of settings including scientific/technical, promotional, patient/consumer, regulatory , and media. + In depth understanding of the business… more
- Merck (Rahway, NJ)
- …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 (North Wales, PA)
- …SAS/MACRO, SAS/GRAPH and systems and database expertise; + US and/or worldwide drug or vaccine regulatory application submission experience at the leadership ... the statistical programming activities for multiple and/or large/complex late-stage drug /vaccine clinical development projects. + Develop and execute statistical… more
- Merck (North Wales, PA)
- …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
- 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
- Amgen (Thousand Oaks, CA)
- …delivers to plan. May telecommute. **Requirements:** Master's degree (or foreign equivalent) in Drug Regulatory Affairs, Biology, Chemistry or related field & 3 ... compilation, organization, and production of protocols, clinical study reports, regulatory submissions, or other controlled documentation; Read technical literature… more
- UPMC (Pittsburgh, PA)
- …include ensuring the safe and effective use of medications, drug dispensing, antibiotic stewardship, controlled substance reconciliation, regulatory ... in accordance with the Pennsylvania Pharmacy Practice Act, Federal Drug Laws, and other regulatory organizations. * Identify and report suspected adverse drug… more
- Danaher Corporation (Fargo, ND)
- …if you also possess previous experience in: + Working knowledge of current industry drug substance and drug product regulatory guidelines Aldevron, a Danaher ... RNA role is responsible for overseeing multiple new technical transfer activities involving Drug Substance and Drug Product program life cycles from development… more