- 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
- Dana-Farber Cancer Institute (Boston, MA)
- …checklists. Requiring an ability to learn and work within multiple sets of regulatory compliance requirements, and performing complex decision tree procedures in ... is performed within standards as established by FACT, the FDA , NMDP, and JC, and the specific protocol under...them in accessing appropriate staff and resources to ensure compliance and support the best possible outcomes. **This is… more
- Cognizant (Boston, MA)
- …12 yrs. of experience :_** **Deep Knowledge of GxP Regulations** Strong understanding of FDA , EMA, MHRA, and other global regulatory requirements (eg, 21 CFR ... seamless integration across platforms. - Coordinate CSV activities to ensure compliance with regulatory standards. - Utilize ALM tools to manage and streamline… more
- Cardinal Health (Boston, MA)
- …is seeking a driven and skilled attorney with expertise in healthcare regulatory compliance , including third party billing and reimbursement. The Assistant ... to commercial, corporate securities, intellectual property, labor and employment, and regulatory law, among other areas. This function also litigates all company… more
- AbbVie (Worcester, MA)
- …mostly through lab and/or pilot plant based activities. + Responsible for compliance with all applicable Corporate and Divisional policies and procedures. + ... handling of materials, controlled drug and radioactive compounds, GxP compliance , and animal care where applicable. Qualifications Qualifications + Bachelors… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …seeking a highly skilled, self-motivated **Senior Validation Specialist- CSV** to ensure compliance of computerized systems with regulatory requirements in the ... will be responsible for planning, executing, and documenting validation activities to meet FDA and potentially other global regulatory standards such as 21 CFR… more
- Hologic (Marlborough, MA)
- …join our dynamic team! In this role, you'll execute activities to ensure compliance with regulatory standards and Quality Management System requirements, conduct ... MA, United States Are you passionate about ensuring top-notch quality and compliance in manufacturing? We're looking for a detail-oriented and proactive **Supplier… more
- BioLife Plasma Services (Boston, MA)
- …exceptional customer service by assisting with production tasks while maintaining strict regulatory compliance and safety standards. + **Develop Leadership and ... program, gain hands-on experience in operational production, including financial, regulatory , administrative, marketing, quality, facilities, and people management. Gain… more
- Integra LifeSciences (Braintree, MA)
- …environmental control issues. + Ensure compliance with safety, environmental, and regulatory standards (eg, FDA , ISO). + Maintain accurate records of ... regulated industries and a strong understanding of refrigeration systems, compliance standards, and preventive maintenance practices. **Key Responsibilities:** +… more