- J&J Family of Companies (Danvers, MA)
- …Clinical Research Scientist will oversee clinical studies within the Clinical and Regulatory Affairs department. The ideal candidate will be able to directly ... building with study steering committee and principal investigators and communication with FDA + Work closely with biostatistics team to evaluate study design options… more
- Takeda Pharmaceuticals (Boston, MA)
- …cross-functionally to ensure scientific rigor and compliance with regulatory standards in all decision-making processes. **Accountabilities:** **A Senior ... years' experience + Experience with at least one NDA/CTDs or other regulatory submissions + Experience representing Statistics function in interactions with … more
- Sanofi Group (Cambridge, MA)
- …strategy and the network of collaborators from preclinical research to operational, regulatory , and commercial functions. Success in this role requires the ability ... of responsibility. The GPH will be responsible for interaction with regulatory authorities, approval of protocols, informed consent documents, clinical study… more
- Pfizer (Cambridge, MA)
- …clinical study reports (CSRs), investigator brochures, statistical analysis plans, and regulatory documents. + Foster a transparent environment that builds strong ... external partners, such as project leaders, research units, biostatistics, regulatory affairs, clinical pharmacology, human genetics, translational oncology, precision… more
- Cytel (Cambridge, MA)
- …analyses to support submission or Health Authority Questions. Having exposure to regulatory work experience is a bonus, for example, if you understand the ... regulatory questions and translating them to statistical problems, collaborating...methodology and consequences of decisions. + Understand and follow FDA regulations which affect the reporting of clinical trial… 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
- Staples (Framingham, MA)
- …safety programs. + Developing and enforcing policies that ensure products meet regulatory requirements and company specifications. + Leading root cause analysis and ... process improvements. + Championing continuous improvement and adapting to changing regulatory and consumer requirements. + Preparing and delivering quality and… more
- Sumitomo Pharma (Boston, MA)
- …collection systems and final reports in compliance with appropriate scientific/ regulatory /medical standards + Contributes to developing clinical components of ... BLA/NDAs, sNDAs, MAAs and other regulatory filing documents + Contributes to company responses to...travel **Key Core Competencies** + Knowledge and understanding of FDA , GCP, and ICH regulations and guidance + Thorough… more
- Sumitomo Pharma (Boston, MA)
- …and at CMO sites. + Lead author for applicable sections in regulatory submissions. + Participate in all validation activities pertaining to commercial products ... ( regulatory starting materials, drug substances, and drug products). +...products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma… more
- Hologic (Marlborough, MA)
- …impact on healthcare innovation. **Knowledge:** + In-depth knowledge of ISO 13485, FDA regulations, EU MDR/IVDR, and cGMP, ensuring regulatory compliance and ... actions, and support design transfers while leveraging your expertise in regulatory compliance and quality systems. If you're a proactive problem-solver with… more