- Sanofi Group (Cambridge, MA)
- …scenario development + Informed market access input to clinical development plan & pivotal trial design + Early market access plan + Early payer value proposition + ... Payer evidence plan and IEGP support, in partnership with HEVA, to ensure it supports the Payer Value proposition + As part of the GPT and early commercialization team: + Contributes to the formulation and execution of the asset(s) strategy and ensure key… 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
- Beth Israel Lahey Health (Boston, MA)
- …Statistician and is accountable for study level deliverables. + Performs trial statistician responsibilities as needed, including attendance of study team meetings, ... review of protocols/amendments, conducting exploratory data analyses, and performing just-in-time analyses. + Applies innovative statistical approaches to study design, analysis and data exploration methodologies. + Serves as a general clinical development and… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Serve as a strategic partner and change agent, shaping clinical trial delivery transformations, guiding GCP strategy, and aligning quality initiatives with ... enterprise priorities and a culture of learning. **ACCOUNTABILITIES** + Identify and lead innovative transformation initiatives across CPMQ, aligning with Takeda R&D and Global Quality objectives. + Develop and execute strategic plans that enhance operational… more
- Takeda Pharmaceuticals (Boston, MA)
- …ensuring on-time test development and deployment in a global clinical trial setting, interfacing with key internal stakeholders and external diagnostic partners, ... and supporting health authority meetings and regulatory submissions (PMAs etc). This role will partner closely with key functions across Takeda Oncology including Translational Medicine, Clinical Sciences, Global Regulatory Affairs, the Oncology Business Unit… more
- ThermoFisher Scientific (Worcester, MA)
- …research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve ... health outcomes that people and communities depend on - now and in the future. Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …actions are implemented. + Actively participates in Takeda R&D's clinical trial delivery oversight and operating model improvements and enhancements, championing ... clear accountabilities, continual improvement and mitigations for past risks. + Ensures the identification, investigation and timely mitigation of quality issues and risks at the development programs and studies. Escalates these issues and issues to senior… more
- Candela Corporation (Marlborough, MA)
- …management reporting package, including manual trial balanceandautomatedSmartViewfilesforBalanceSheet,StatementofCashFlows,andP&Lwith Adjusted EBITDA calculation. o ... Assistwithmonthlyandquarterlyexternalreporting o AssistwithmanagingtheglobalBalanceSheetfluxfile. o MaintainthecurrentsuiteofSmartView-enabledreportstoensureup-to-dateaccountmappings. o… 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
- ThermoFisher Scientific (Plainville, MA)
- …implementing manufacturing processes to produce early- and late-phase human clinical trial and commercial gene therapy products. **RESPONSIBILITIES:** + MST process ... lead for Downstream technology transfer activities involved in manufacturing viral vectors following cGMP guidelines. + Collaborate with other sites or clients to ensure success of process transfer and scale up. + Ensure effective information flow, risk… more