- 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
- 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
- Merck (North Wales, PA)
- …projects under supervision in Late Development Statistics. + Interacts with Clinical , Regulatory , Statistical Programming, Data Management and other company ... analyses. + Prepares oral and written reports to effectively communicate results of clinical trials to the project team, management, regulatory agencies, or… 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
- 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
- UNC Health Care (Chapel Hill, NC)
- …evaluations, donor searches, and treatment planning. Oversees outpatient care. 5. ** Regulatory Compliance ** Maintains accurate and timely documentation in the ... team. Monitors discharge needs and follow-up care per program standards 5. Regulatory compliance --documents and maintains patient transplant information in the… 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
- UnityPoint Health (Waterloo, IA)
- …the Market Leadership team, the Market Chief Medical Officer (CMO) leads clinical /provider performance for the market. This role aligns and maximizes provider ... Organized Medical Staff and Administration and externally as the primary liaison for clinical matters to the larger physician community in the market service area.… more