- Insmed Incorporated (NJ)
- …of R or other statistical software packages Significant knowledge of the drug development process, clinical trial methodology, and relevant regulatory ... team members within Biometrics, Clinical Operations, Regulatory, and Clinical Development , as well as with external vendors. Oversees contractors...requirements for drug approval Significant experience in global regulatory submissions Extensive… more
- Insmed Incorporated (NJ)
- …is preferred.Knowledgeable in all aspects of clinical operations, project management, the drug development process, and clinical trial conduct, including systems ... implement and manage a process for Inspection Readiness.Contributes to the development and review of regional/global policies and procedures. Ensure compliance with… more
- Merck & Co. (Rahway, NJ)
- …820, ISO 13485, ISO 14971). - This position will interact with cross-functional development teams within and external to Device Development . The incumbent must ... employees and be able to effectively coordinate the execution of device development strategies and drive continuous improvement in design control and risk management… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Principal Scientist, Drug Discovery in our Research and Development Department will be responsible for identifying new molecular entities and ... the early research and proof-of-concept phase up to the development stage. She/he/they will interface with researchers and senior...of 8 years industry or pharmaceutical research experience in drug discovery or preclinical research with a focus on… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …substance applications will be a plus. Skills: Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing ... strategies for CMC aspects of small molecule products during late-stage development and throughout the commercial lifecycle. This includes initial marketing… more
- Banner Health (Phoenix, AZ)
- …other related area) and effectively communicates to stakeholders. Participates in the development of innovative drug -related patient care practices in their ... and medication safety. Expected to participate in educational initiatives and staff development ; develop and provide oversight for the quality assurance of clinical… more
- Insmed Incorporated (NJ)
- …of relevant guidelines including, but not limited to medical and regulatory affairs, drug development , FDA and regulatory guidelines (ie, PhRMA guidelines, OIG, ... the future to ensure readiness and effectiveness of the team.Strategy Development -Partner across medical affairs and cross-functionally to develop strategy relating… more
- Novo Nordisk Inc. (Boulder, CO)
- …with a High School diploma is required Strong background in oligonucleotide-based drug substance development and manufacturing including knowledge of nucleic ... About the Department Our Research & Development organization brings together the best minds in...full R&D continuum, from early research through late-stage clinical development . Here, we are building for the future, creating… more
- Catalent Pharma Solutions (Kansas City, MO)
- …development . Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 ... in pharmaceutical fields including managerial roles; Experience with sterile and blood drug product development , manufacturing and testing is strongly preferred;… more
- Otsuka America Pharmaceutical Inc. (Oklahoma City, OK)
- …and performing root cause analysis. Thorough understanding of GMP requirements and the Drug Development process. Knowledge of FDA 21 CFR Parts 210 and ... supply for Otsuka's patients. Job Description Provides Biologics QA support for Drug Substance and Drug Product, including upstream and downstream biologics… more
