- Pfizer (Cambridge, MA)
- …contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents; supports ... Strong knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA , EMA, and global regulations. + Strong scientific writing skills and… more
- Charles River Laboratories (Shrewsbury, MA)
- …study management, interpretation, and reporting of study data and assuring the regulatory compliance of these projects, as appropriate. Serve as a Project Scientist ... in accordance with company standard operating procedures and industry regulatory guidelines. This position will serve as the primary...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… more
- Takeda Pharmaceuticals (Boston, MA)
- …with Pharmaceutical Sciences team to generate preclinical data package for regulatory filings (IND) and translatable biomarker strategies for patient stratification. ... execution and interpretation of experiments in compliance with appropriate global regulatory guidance. + Effective and independent management of both internal and… more
- Children's Hospital Boston (Boston, MA)
- …committees related to transfusion medicine. + Ensures compliance for inspection by regulatory bodies overseeing hospital enterprise wide transfusion ( FDA , AABB ... errors, and near misses to providers, hospital leadership and appropriate regulatory agencies. + Collaborates with physicians, nursing, and quality programs to… more
- Beth Israel Lahey Health (Boston, MA)
- …and organizational regulatory guidelines and uphold requirements for CAP, JC, FDA , AABB, FACT and others. Work collaboratively with hospital quality and ... staffing of pathology laboratories in compliance with institutional and regulatory standards. Ensures appropriate hiring, training and development of competent… 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 ... programs. + Conduct routine safety observations to ensure compliance with regulatory agencies, company environmental, health, and safety policies, procedures and… more
- Charles River Laboratories (Shrewsbury, MA)
- …management, interpretation, and reporting of study data and assuring the regulatory compliance of these projects, as appropriate. Additional responsibilities include ... in accordance with company standard operating procedures and industry regulatory guidelines. This position will serve as the primary...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… more
- Cardinal Health (Boston, MA)
- …to commercial, corporate securities, intellectual property, labor and employment, and regulatory law, among other areas. This function also litigates all company ... is seeking a driven and skilled attorney with expertise in healthcare regulatory compliance, including third party billing and reimbursement. The Assistant General… more
- Lilly (Boston, MA)
- …generated both internally and externally are in line with quality and regulatory expectations. + Understand in-process and final product critical quality attributes ... and approve test protocols, SOPs, technical reports, and relevant sections of regulatory submissions. Participate in regulatory interactions as needed. **Basic… more
- Cardinal Health (Boston, MA)
- …hours. We also provide customers the support they need in regulatory compliance, reimbursement, continuing education, information management and other crucial areas, ... of medical affairs professionals who report to the Sr Director of Regulatory & Medical Affairs. **Responsibilities:** + Collaborate across multiple functions and… more