questions in a timely and efficient manner Support the delivery of MI to HCPs and patients to meet Market and Regulatory needs...
Regulatory & Medical Affairs - Project Manager Job Number: 25-05400 Be part of a company that delivers life-changing... healthcare solutions. ECLARO is looking for a Regulatory & Medical Affairs - Project Manager for our client in Lawrence Township...
of medical affairs functions, US healthcare environment, and regulatory requirements. Project Management Professional (PMP...
civil engineering projects from conceptualization through to completion, ensuring compliance with regulatory standards... project elements seamlessly. Interface with clients, contractors, and regulatory agencies to address project-related issues...
patient care and maintain accurate records in compliance with organizational and regulatory requirements. Training: Provide...
processes in partnership with cross functional Business Process Owners (e.g. Biostatistics, Regulatory, Clinical Development... is a plus); within Drug Development (Clinical Development, Trial Operations, Biostatistics, Regulatory, Safety, Project Management...
of Microsoft Office and Computer Skills Ability to respond to common inquiries or complaints from customers, regulatory agencies...
of all operational activities to ensure audit readiness and regulatory compliance. Identify and implement opportunities for continuous...
and regulatory environment, integrating scientific insights and compliance requirements to influence brand and disease strategies... and creator of scientific materials (including slides, scientific narratives, and responses). Ability to apply regulatory (FDA...
Owners (e.g. Biostatistics, Regulatory, Clinical Development, Safety and Clinical Trial operations). This position... (Clinical Development, Trial Operations, Biostatistics, Regulatory, Safety, Project Management, etc). Familiarity with relevant...
, Regulatory, Clinical Development, Safety and Clinical Trial operations). This position will be critical to enabling the..., Biostatistics, Regulatory, Safety, Project Management, etc). Familiarity with relevant technologies and tools used in business...
is accurate and complete. Complies with department procedures and regulatory guidelines for HIPAA, Advance Beneficiary Notice...
and plan executions Attending MLR as champion/owner of project to address medical, legal, and regulatory conversations in real...
. Attending MLR as champion / owner of project to address medical, legal, and regulatory conversations in real time as it adheres...
and regulatory filing. Essential Functions: Develops, validates, and implements immunoassays for the analysis of clinical... assay performance meets regulatory expectations for specificity, sensitivity, precision, accuracy, and robustness...
objectives and regulatory standards. Contribute to the preparation of project reports, presentations, and client...
manner. Support the delivery of MI to HCPs and patients to meet Market and Regulatory needs. Provide MI guidance...
compounds in biological samples to support drug development and regulatory filings. Essential Functions: Perform method...) for quantitation, data handling and archival Knowledge of GLP, 21 CFR Part 11, Regulatory Bioanalytical Guidance and general...
is accurate and complete. Complies with department procedures and regulatory guidelines for HIPAA, Advance Beneficiary Notice...