- Nanobiosym, Inc. (Cambridge, MA)
- …and AI related patents. The ideal candidate will hold a Ph.D. in a Physical science and or life sciences discipline and have at least 10+ years of IP law ... matters, including licensing agreements, collaborations, M&A due diligence, and regulatory submissions. + Dispute Resolution: Support IP litigation, opposition… more
- Sanofi Group (Waltham, MA)
- …to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions ... **About You** **Experience:** + Minimum requirements (Sr. Engineer level): PhD with 4+ years, MS with 6+ years, or...to and in a GMP environment + Knowledge of regulatory requirements for process changes and technology implementation +… more
- Cambrex High Point (Waltham, MA)
- …including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science , material characterization, and highly potent APIs. Your Work ... an MS with 5+ years of experience, or a PhD with 1+ years of experience in analytical chemistry...to characterize and quantitate pharmaceutical synthetic molecules. Knowledge of regulatory guidelines and experience in quality control testing are… more
- Bristol Myers Squibb (Cambridge, MA)
- …pharmacokinetics activities of multiple projects; be responsible for preparation of regulatory dossier / submissions; and assist in developing strategy for the ... DSUR, etc. to support clinical trials and global registrations. Interacts with regulatory authorities to address questions as needed. + Support clinical assets for… more
- Sanofi Group (Cambridge, MA)
- …to improve patient outcomes by accelerating proper integration of our cutting-edge science into US clinical practice. We are an innovative global healthcare company, ... products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on… more
- Charles River Laboratories (Shrewsbury, MA)
- …topline revenues and maintaining consistently high margins. o Identify and foster science -related initiatives and capabilities. o Provide a focal point for assessing ... and proposals for improvement and effect their implementation. o Identify key science -based issues needing discussion at the appropriate meeting venue and contribute… more
- Merck (Boston, MA)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... to individual contributors + Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics and authoring … more
- Chiesi (Boston, MA)
- …narratives for global stakeholders. + Partner with R&D, clinical development, regulatory , and commercial teams to ensure seamless, consistent messaging across all ... global early access and compassionate use programs, ensuring compliance with varied regulatory frameworks (eg, FDA, EMA, and other health authorities). + Leverage AI… more
- Takeda Pharmaceuticals (Boston, MA)
- …mission. **POSITION OBJECTIVES:** The purpose of this position is to provide data science expertise by: + Providing statistical support in the design, analysis, and ... imaging data or sensor data + Applying state-of-the-art data science methodologies (taken from statistics, machine learning, and AI)...+ Education in a relevant field, for example a) PhD in a field such as Biostatistics, Applied Mathematics,… more
- Sanofi Group (Waltham, MA)
- …at extended clinical team meetings and may attend external meetings with regulatory agencies and key opinion leaders. We are an innovative global healthcare ... and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a...(CROs) + Links with other internal stakeholders (such as Regulatory Managers or Product Safety Officers in Pharmacovigilance for… more