- Parexel (Washington, DC)
- …Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining ... preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural...audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures… more
- Parexel (Washington, DC)
- …to safeguard the quality of investigator sites (eg patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement ... + Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators + Drive Quality Event (QE) remediation,… more
- Parexel (Washington, DC)
- …to safeguard the quality of investigator sites (eg patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement ... + Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators + Drive Quality Event (QE) remediation,… more
- Parexel (Washington, DC)
- …Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining ... preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural...audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures… more
- Parexel (Washington, DC)
- …deliverable timelines, project leadership, and training and support of junior medical writing staff. **Key Accountabilities** : **Author Clinical Documents** ... **Job Summary:** The Senior Medical Writer will research, create, and edit all...mock statistical output to determine appropriateness of content/format for clinical writing. ** Quality Control** + Ensure that… more
- Parexel (Washington, DC)
- … Medical Writer will research, create, and edit all documents associated with clinical research. The Senior Medical Writer may operate as the project lead ... clinical data presented in summary documents is in compliance with applicable regulatory guidelines, SOPs, and goals of... writing and regulatory issues. + Develop and train Medical Writing Services staff to enhance writing quality… more
- Battelle Memorial Institute (Arlington, VA)
- …environment. This position applies professional health nursing principles and clinical expertise to analyze and address complex patient needs, ensuring ... full range of professional health nursing principles, practices, and procedures in clinical settings to analyze the full scope of problems associated with providing… more
- Parexel (Washington, DC)
- …the medical authority on safety profiles for assigned products, ensuring compliance with global regulations while providing critical medical insights. You'll ... and for various signal management activities **CSR Narratives (as applicable)** + Performing medical review of Clinical study report narratives according to the… more
- Parexel (Washington, DC)
- …responsible for site start-up, activation, relationship management, recruitment, and quality assurance. This role also contributes to site selection, provides ... issues, and collaborates with various functions to optimize communication, maintain site quality and patient safety utilizing data analytics to identify and mitigate… more
- GRAIL (Washington, DC)
- …with 10+ years of experience in regulatory, development, clinical affairs, quality , or program management within the IVD, medical device, or pharmaceutical ... with internal teams to implement appropriate changes. + Support internal and external quality audits. + Ensure compliance with all regulations and laws… more
- Parexel (Washington, DC)
- …Promotion & Artwork** + Review and approve direct-to-consumer and marketing advertising, medical education, and social media content for compliance . + Manage ... the world, ensuring innovative products are supported by clear, compliant, and high- quality documentation that enables safe and effective use across global markets?… more
- Parexel (Washington, DC)
- …West Coast hours. **About Us:** At Parexel, we are dedicated to advancing clinical research and supporting medical affairs with innovative solutions. We are ... management / Biometrics ( clinical trial data and/or Real World Data) + Medical affairs experience (Phase IIIB - IV trials experience); Late Phase Oncology +… more
- Sun Pharmaceuticals, Inc (Washington, DC)
- …mandates, and quality programs related to value based care and clinical care pathways. Responsibilities include: + Incorporate knowledge of dynamic and complex ... of Sun products. + Has a deep understanding of medical vs pharmacy benefit and policy + Understands the...conventions when requested. + Ensure behaviors consistent with Healthcare Compliance guidelines Job Qualifications Education: A minimum of a… more
- Washington Metropolitan Area Transit Authority (New Carrollton, MD)
- …and compliance standards. + Validate data sources, maintain data quality , and contribute to data standardization efforts to comply with regulatory standards. ... informatics capabilities enhancing surveillance, supporting evidence-based decision-making, and ensuring compliance with regulatory and organizational standards. The ideal candidate… more
- Somatus (Mclean, VA)
- …FP&A and operational finance, partnering with leaders across MedEcon, Analytics, Clinical Performance, and Provider Finance. Your work will fuel smarter decisions, ... financial plan. + **Streamline** systems and processes to improve efficiency and quality . + Support capital raising by preparing due diligence materials and… more
- Otsuka America Pharmaceutical Inc. (Washington, DC)
- …The Senior Manager of Global Quality Management (GQM) supports the execution of clinical quality activities to ensure compliance with Good Clinical ... noncompliance. + Collaborate with Clinical Operations, Regulatory Affairs, and Medical Affairs to embed quality practices throughout the study lifecycle.… more
- Otsuka America Pharmaceutical Inc. (Washington, DC)
- …or related field; advanced degree preferred. + 3 -5 years of experience in clinical quality assurance or GCP auditing within the pharmaceutical, biotech, or CRO ... The **Global Quality Audit Manager** is responsible for planning, executing,...executing, and reporting on global audits to ensure **Good Clinical Practice (GCP) compliance ** across Contract Research… more
- Alaka'ina Foundation Family of Companies (Silver Spring, MD)
- …with health and safety regulations. + Develop and implement clinical quality improvement initiatives. + Monitor compliance with regulatory requirements and ... Clinical Quality Control Specialist Location MD...Eligible employees enjoy a 401K plan with company match; medical , dental, disability, and life insurance coverage; tuition reimbursement;… more
- Immigration and Customs Enforcement (Washington, DC)
- …health facility surveyors and in collaboration with the IHSC Medical Quality Management Unit. SUPERVISORY CONTROLS: The Clinical Senior Nurse Specialist, ... developing and accessing clinical health outcomes quality measures; evaluating clinical case reviews for adequacy of care, compliance with clinical … more
- Highmark Health (Washington, DC)
- …and/or monitor actionable opportunities for improving health and healthcare outcomes and clinical quality and costs of care, efficiently and effectively managing ... incumbent will act as a primary owner of assigned medical policies, ensuring their accuracy, clinical soundness,...lower per capita health care costs, improved outcomes and quality of care received, and optimal member/patient and provider… more
