- Takeda Pharmaceuticals (Cambridge, MA)
- …(PK/PD/Efficacy/Safety/biomarkers/RWE/RWD) across the asset to drive dose selection, optimized trial design, and quantitative decision making. + Familiar with ... regulatory guidance and submission process across different regionals. + Experience in representing the QCP function in interactions with global or regional regulatory agencies at significant development milestones such as pre-submission, and pediatric… more
- Takeda Pharmaceuticals (Boston, MA)
- …continuous improvement + Strong understanding of GCP, ICH guidelines, and clinical trial regulations **ADDITIONAL INFORMATION** + The position will be based in ... Cambridge, MA.This position is currently classified as "hybrid" by Takeda's Hybrid and Remote Work policy. **Takeda Compensation and Benefits Summary** We understand compensation is an important factor as you consider the next step in your career. We are… more
- Beth Israel Lahey Health (Charlestown, MA)
- …various General Ledger accounts including bank accounts and accounts receivable aged trial balances. 6. Assists with reconciliation of physical inventories; from the ... inventory count and input, reconciliation to General Ledger, determines reasons for differences and prepares inventory statements. 7. Reviews vendor invoice coding and makes necessary accounting adjustments to ensure correct posting of expenses. 8. Prepares… more
- Bausch + Lomb (Boston, MA)
- …SOPs. + Responsible for the quality of all study-related documentation (eg, Trial Master File, site qualification and initiation visits reports, interim monitoring ... visit reports, clinical monitoring plan, informed consents, CRF completion guidelines, pharmacy manual, etc.) during study start-up and throughout the life of the project to ensure that procedures are followed in an appropriate and consistent manner. + Oversee… more
- Takeda Pharmaceuticals (Lexington, MA)
- …global reporting + Oversee and manage core tasks for Analytical controls for clinical trial material efforts across four main areas: a) GMP review and control for ... analytical documents; b) Release testing oversight, Stability and Shelf life; c) Reference Standard Management; d) GMP Quality Systems + Contribute to product development from Research to Commercialization by collaborating with multiple functions within the… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …the context of the medical significance to individual patients. + ** Trial Medical Monitoring** + Responsible for medical monitoring activities, assessing issues ... related to protocol conduct and/or individual subject safety. Assesses overall safety information for studies and compound in conjunction with Pharmacovigilance. Oversees non-medical clinical scientists with respect to assessment of these issues. + Makes final… more
- State of Massachusetts (MA)
- …courts (including Juvenile, District and Superior Court as appropriate). * Handle pre- trial hearings and conferences and litigating the full range of evidentiary and ... non-evidentiary motions. * Handle trials, pleas, sentencing, and post-conviction matters. * Serve in an "on-call capacity" as needed. * Mentor District Court ADAs. * Work closely with colleagues, office staff, victim witness advocates, law enforcement… more
- Sanofi Group (Cambridge, MA)
- …of novel biomarker and precision medicine approaches, novel clinical trial designs, endpoints and statistical methods **About You** **Basic Qualifications:** ... + Medical Doctor. Should be board certified or equivalent in internal medicine / clinical immunology. Pulmonology is a plus. + Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical… more