- Formation Bio (New York, NY)
- …industry Proven track record in leading toxicology efforts in late-stage drug development Strong understanding of regulatory requirements for toxicology ... is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more… more
- Merck & Co. (Rahway, NJ)
- …the job, you will begin to develop a comprehensive understanding of global regulatory expectations of drug and vaccine development, including clinical trial ... Pharmacology and Pharmacometrics (QP2) apply quantitative approaches to enable drug -development decision-making from drug discovery through approval.Senior… more
- Insmed Incorporated (NJ)
- …E xpert knowledge of relevant guidelines including, but not limited to medical and regulatory affairs, drug development, FDA and regulatory guidelines (ie, ... PhRMA guidelines, OIG, AMA, ACCME, Sunshine Act, etc.)Global mindset with understanding of US, European, and Japanese marketsForward looking with continuous process improvement mentalityStrong strategic thinking with ability to connect multiple… more
- Insmed Incorporated (San Diego, CA)
- …will provide clinical and scientific support to clinical development and operations, regulatory , medical affairs, drug safety, and quality assurance teams, as ... scientific review of information to support the development and updates for regulatory documents (ie, IND submissions, IND Annual Updates, DSUR, and Investigator… more
- Insmed Incorporated (NJ)
- …of the drug development process, clinical trial methodology, and relevant regulatory requirements for drug approval Significant experience in global ... Collaborates with cross-functional team members within Biometrics, Clinical Operations, Regulatory , and Clinical Development, as well as with external vendors.… more
- Merck & Co. (Rahway, NJ)
- …degree is preferred.Leadership experience with working knowledge of device, biologic/ drug product, and process development including regulatory submission ... & Process Development (DPPD) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe and… more
- Syner-G BioPharma Group (Boston, MA)
- …of clients across the life sciences industry, supporting critical phases of the drug development lifecycle, from discovery and regulatory approval to technology ... strategic partner for life science companies. We provide integrated regulatory and biopharmaceutical development services spanning early development to post-market,… more
- Syner-G BioPharma Group (Boston, MA)
- …of clients across the life sciences industry, supporting critical phases of the drug development lifecycle, from discovery and regulatory approval to technology ... strategic partner for life science companies. We provide integrated regulatory and biopharmaceutical development services spanning early development to post-market,… more
- Syner-G BioPharma Group (Boston, MA)
- …of clients across the life sciences industry, supporting critical phases of the drug development lifecycle, from discovery and regulatory approval to technology ... strategic partner for life science companies. We provide integrated regulatory and biopharmaceutical development services spanning early development to post-market,… more
- Insmed Incorporated (NJ)
- … drug safety topics, clinical and safety data to regulatory authorities, health authorities, or at conventions, meetings, etc.Global Pharmacovigilance experience, ... applicable ICH guidelines.Experience in preparing clinical safety assessments and regulatory reports/submissions involving safety information.Experience in drug … more
