- Sanofi Group (Seattle, WA)
- …Affairs colleagues, Medical Information and Commercial Operations) while maintaining full compliance with relevant company, industry, legal and regulatory ... during one-on-one interactions and group settings, exhibiting excellent scientific and clinical knowledge. + Uses strong knowledge of relevant diseases and disease… more
- Sanofi Group (Framingham, MA)
- …bridges the gap between technical development, manufacturing operations, and global regulatory authorities to ensure compliance while optimizing product approval ... across R&D, Device, Manufacturing, and Quality teams while preparing high-quality regulatory submissions, managing compliance , and anticipating regulatory … more
- Merck (Providence, RI)
- …strategies and interact with various stakeholders to ensure alignment with clinical development timelines and regulatory requirements. Most importantly, the ... + Deep understanding of scientific concepts, clinical development processes, clinical testing guidelines, and the regulatory requirements for diagnostic… more
- Johns Hopkins University (Baltimore, MD)
- …+ Develop and maintain study documents such as laboratory manuals. + Internally monitor regulatory files and study data to assess compliance , data quality, and ... multi-centered clinical trial. + Develop standard operating procedures for regulatory submissions as needed. + Maintain a continued high level of expertise… more
- Cognizant (Boston, MA)
- …phases for systems supporting drug development, clinical data management, regulatory submissions, and digital documentation. . Ensure compliance with ... advanced degree preferred. Certifications: (Optional) ISTQB, PMP, or relevant regulatory compliance certifications. **_Roles & Responsibilities_** Develop and… more
- Highmark Health (Pittsburgh, PA)
- …understanding of care management principles, operational efficiency, financial performance, and regulatory compliance . The Director will lead and develop ... modeling to proactively identify at-risk members and improve engagement strategies. + ** Regulatory Compliance :** Maintain compliance with all applicable… more
- Johns Hopkins University (Baltimore, MD)
- …Treatment Plan development for both new submissions and amendments. + Assures compliance with local & national regulatory standards; as appropriate, prepares ... experience, and internal/external regulations. + Evaluates patients' participation in assigned clinical trials and identifies barriers to compliance . + Plans,… more
- UPMC (Pittsburgh, PA)
- …drug operations, implement advanced clinical research systems, and ensure compliance with dynamic regulatory standards- contributing directly to advancing ... We welcome candidates who are detail-oriented, adaptable, and experienced in clinical trial protocols, investigational drug accountability, and regulatory … more
- Merck (Lower Gwynedd, PA)
- …(eg, neutralizing assays) will be utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility ... aids associated with sample management systems and processes + Perform responsibilities in compliance with departmental SOPs and regulatory guidances (eg, GxP) +… more
- Sanofi Group (Cambridge, MA)
- …Affairs colleagues, Medical Information and Commercial Operations) while maintaining full compliance with relevant company, industry, legal and regulatory ... during one-on-one interactions and group settings, exhibiting excellent scientific and clinical knowledge:** + Uses strong knowledge of relevant diseases and disease… more