- Humana (Boston, MA)
- …+ Computer literate (MS, Word, Excel, Access) + Strong personal and professional ethics + Must be passionate about contributing to an organization focused on ... veteran status. It is also the policy of Humana to take affirmative action, in compliance with Section 503 of the Rehabilitation Act and VEVRAA, to employ and to… more
- Dana-Farber Cancer Institute (Newton, MA)
- …other Harvard Medical School-affiliated hospitals. Administrative: + Assists principal investigator with protocol development. + Assists principal investigator ... appropriate with the Institute's protocol review process. + Assists the principal investigator in developing the protocol budget. + Collaborates with the Dana-Farber… more
- GE HealthCare (Boston, MA)
- …senior business segment and technology/engineering leaders on legal and compliance issues surrounding company-sponsored and investigator -initiated research and ... teams on legal issues related to GE HealthCare sponsored and investigator -initiated research and collaboration proposals and engagements. **Job Description** **Key… more
- Dana-Farber Cancer Institute (Boston, MA)
- …with each TRPM managing a separate portfolio of projects for each investigator . Specific tasks and responsibilities are varied and dependent on the needs ... completion, to meet research objectives. + Grant Support: Assist the Principal Investigator (PI) with grant applications and progress reports, playing a crucial role… more
- Parexel (Boston, MA)
- …solutions. As a member of this team, you will be essential to ensuring our Investigator sites are prepared to start trials, with a focus on reducing Site Activation ... and maintenance of the current Regulatory/Competent Authority (CA) and Ethics Committee (EC) submission information within JVRIM/CTIS, and similar information… more
- Sumitomo Pharma (Boston, MA)
- …closely with Regulatory Operations in the electronic submission + Ensure compliance with global regulatory requirements and adherence to regulatory internal policies ... and processes and coordinate regulatory compliance activities at a global level + Provide updates to the Global Regulatory Team, project teams, and governance boards… more
- Sumitomo Pharma (Boston, MA)
- …the writing of clinical study reports + Contributes to the preparation of Investigator Brochures, annual reports, data collection systems and final reports in ... compliance with appropriate scientific/regulatory/medical standards + Contributes to developing...+ Contributes to company responses to health authorities and ethics committees for ongoing clinical programs to ensure timely… more
- Lilly (Boston, MA)
- …leadership throughout the trial lifecycle, ensuring scientific integrity, regulatory compliance , and patient safety. You will collaborate with cross-functional ... design and development of key clinical documents, including study protocols, investigator 's brochures, informed consent documents, and other essential materials. +… more
- Merck (Boston, MA)
- …**_Compliance and Ethical Leadership_** + Models and enforces the highest standards of ethics and compliance ; ensure all team activities adhere to company ... guidance (including safe field practices such as driver safety). + Owns compliance readiness: continuously assess compliance risks, implement preventive measures… more
- Takeda Pharmaceuticals (Boston, MA)
- …lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees. + Ensure communication of all safety information that may ... in Company Core Data Sheet (including Reference Safety Information) and Investigator Brochure, as well as other labeling documents. + Demonstrate knowledge… more