Management and Clinical Engineering team to define product requirements which meet product manager expectations. Develop... with quality management and regulatory affairs to navigate the approval process. Identify and mitigate technical risks associated...
, concise, and scientifically accurate manner. Work with functional representatives such as regulatory affairs, clinical... programs, producing high quality regulatory and clinical documents that meet regulatory and industry standards...
Management and Clinical Engineering team to define product requirements which meet product manager expectations. Develop... with quality management and regulatory affairs to navigate the approval process. Identify and mitigate technical risks associated...
with regulatory affairs, quality assurance staff, and external clinical system vendors. Mentors less experienced statistical... a plus Experience with regulatory submissions a plus Knowledge of clinical data management systems, e.g., Oracle InForm and/or RAVE...
related data (i.e., Medical Affairs, Clinical Development). Contributes to responses to safety questions from regulatory... to regulatory authority submissions (NDAs, MAAs, Variations) by reviewing safety data and preparing relevant sections of the...
will work with minimal supervision and must use sound judgment to assess prioritization of all regulatory affairs to ensure... timely submissions to regulatory bodies (IRB, UW CTMS, FDA, Sponsor, etc.). Oversee, coordinate, and implement regulatory...
of Pharmaceutical industry experience in Clinical Development Operations or Regulatory Affairs preferred. Working knowledge...Overview: This Regulatory Affairs CONTRACTOR will assist the department with completing regulatory correspondence...
(i.e., Medical Affairs, Clinical Development). Contributes to responses to safety questions from regulatory authorities for assigned...-risk of assigned products, with a focus on post-marketing safety and safety risk management but may include clinical...
, and submit regulatory submissions as required. * May review, analyze, approve, and monitor events logged in event management... Knowledge, Skills and Abilities Advanced knowledge in quality, compliance, regulatory affairs, etc. and broad knowledge...
, concise, and scientifically accurate manner. Work with functional representatives such as regulatory affairs, clinical... programs, producing high quality regulatory and clinical documents that meet regulatory and industry standards...
programming teams/activities for complex clinical development Compound(s), including worldwide regulatory submissions. Represents..., and report clinical trial data in accordance with statistical analysis plans, ICH guidelines, and applicable regulatory...
and maintenance. Partner with Regulatory Affairs to ensure all network filings are timely and accurate. POSITION REQUIREMENTS... change with external provider partners by assessing clinical informatics and offering consultative expertise to assist...
and maintenance. Partner with Regulatory Affairs to ensure all network filings are timely and accurate. POSITION REQUIREMENTS... change with external provider partners by assessing clinical informatics and offering consultative expertise to assist...
strategy for approach to evaluation of issues in the clinical matrix. Leads the safety component of global regulatory... submissions. Expert evaluation skills and analytical thinking for literature review, clinical data synthesis, analysis...