- Sumitomo Pharma (Boston, MA)
- …specifications. + Perform programming validation for key derived datasets and oversee Quality Control (QC) efforts to ensure accuracy in data presentations and TFLs. ... Statistics + Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations + Advanced proficiency in BASE SAS… more
- ThermoFisher Scientific (Waltham, MA)
- …safety studies (PASS), and we partner with our pharma clients to support FDA , EMA, and other regulatory commitments. Within our registry coordination team, we work ... relevant literature as well as existing data, evaluates the quality of data used in reports, and assists with...Abilities Extensive knowledge of at least one major statistical software package such as Stata, SAS or R is… more
- Mentor Technical Group (Boston, MA)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... to correct job-skill deficiencies. + Manages the employee's Time Keeping equipment/ software function process. + Requisition materials and supplies, such as tools,… more
- Schrodinger (Framingham, MA)
- …to join us in our mission to improve human health and quality of life through the development, distribution, and application of advanced computational ... classes and therapeutic areas. We're supported by over 100 software developers and engineers, as well as a large-scale...achieved development candidates, including progression to the clinic and FDA approval. You can view our entire pipeline of… more
- Takeda Pharmaceuticals (Lexington, MA)
- …analyzes and interprets data using existing standard procedures, digital platforms and software tools. Support in silico activities to align with internal strategy ... required. **Knowledge and Skills:** + Awareness of developing and commercializing FDA regulated devices / combination products under Design Control regulations and… more
- Fresenius Medical Center (Lawrence, MA)
- …by applying human factors engineering principles to optimize usability, cost, quality , safety, and performance. Specific duties include: + Represent product ... devices including translating user needs into design requirements and developing software applications to improve knowledge retention and reduce training time of… more