- Baystate Health (Springfield, MA)
- …leaders in matters of corporate law, business transactions, financing, medical staff, regulatory compliance , health law, legal aspects of drug diversion ... by state/federal agencies such as Attorney General's office, federal FDA or DEA, HCFA, State Board of Registration in...Work Experience:** Corporate transactions, medical staff and health care regulatory compliance , advice related to the legal… more
- Sumitomo Pharma (Boston, MA)
- …encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and ... and manages Safety Charters + Handles Health Hazard Evaluations and Ad-Hoc Regulatory safety inquiries. + Represents PVRM on post-marketing product specific and/or… more
- Catalent Pharma Solutions (Chelsea, MA)
- …testing is conducted in line with the appropriate expectations, guidelines and/or regulatory test standards. **This is a full-time on-site salaried position: Monday ... is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer, and Catalent employee.** **The… more
- Sumitomo Pharma (Cambridge, MA)
- …Integrated Summary of Efficacy (ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with ... Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus...considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and… more
- Danaher Corporation (Waltham, MA)
- …the Caribbean. This role provides legal guidance on a wide range of commercial, compliance , and regulatory matters, with a particular focus on Latin America. The ... and stay aligned with relevant laws and regulations, including healthcare compliance (eg, Anti-Kickback Statute), FDA regulations, anti-corruption (eg, FCPA),… more
- Children's Hospital Boston (Boston, MA)
- …related to transfusion medicine. + Ensures compliance for inspection by regulatory bodies overseeing hospital enterprise wide transfusion ( FDA , AABB and the ... errors, and near misses to providers, hospital leadership and appropriate regulatory agencies. + Collaborates with physicians, nursing, and quality programs to… more
- Takeda Pharmaceuticals (Lexington, MA)
- …design verification and validation testing, risk assessments, DHF creation, regulatory submission authoring, general project team technical support, and extensive ... / implement contingency plans as required. + Lead the project execution in compliance with design control SOP. Oversee technical aspects of the development process… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …potentially formulation/fill-finish operations. + Experience with cGMP manufacturing environments and regulatory requirements ( FDA , EMA, ICH). + Familiarity with ... This role is responsible for ensuring the robustness, scalability, and compliance of downstream operations through effective technology transfer, validation support,… more
- Takeda Pharmaceuticals (Boston, MA)
- …new development programs. + Independent execution and interpretation of experiments in compliance with appropriate global regulatory guidance. + Effective and ... with Pharmaceutical Sciences team to generate preclinical data package for regulatory filings (IND) and translatable biomarker strategies for patient stratification.… more
- Beth Israel Lahey Health (Boston, MA)
- …operations. 4. Ensures appropriate staffing of pathology laboratories in compliance with institutional and regulatory standards. Ensures appropriate ... and organizational regulatory guidelines and uphold requirements for CAP, JC, FDA , AABB, FACT and others. Work collaboratively with hospital quality and … more