and other key stakeholders through education on up to date scientific information in alignment with US, Global, and Area Business... in alignment with local health care system and medical strategy; Leverage knowledge of US and Global definitions and strategies...
on approving results to be released within the LIMS. Review all data discrepancies and monitor for accuracy Attend investigator.... Is familiar with 21 CFR part 11 and computer system validation requirements Works with QA to ensure regulatory compliance...
for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study... including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. Ensures compliance with the...
Affairs, Global Clinical Supply Chain, Drug Safety, Information Technology, Compliance and Legal departments... their successful implementation. The Associate Medical Affairs Operations Director contributes to key aspects of the investigator sponsored trial...
for approved, in-development, and active Company-sponsored trials and/or investigator-sponsored research studies and serve.... Consistent adherence to field and corporate policies and Global Medical Scientific Affairs (GMSA) strategy, including field...
, Microsoft Teams) Duties may require compliance with client requirements that all those performing services on-site be fully... care professionals. Work with stakeholders of investigator-initiated trials Provide approved information to customers...
, Microsoft Teams) Duties may require compliance with client requirements that all those performing services on-site be fully... care professionals. Work with stakeholders of investigator-initiated trials Provide approved information to customers...
level of proficiency with support technology (PC and CRM tools, Microsoft Teams) Duties may require compliance with client..., personnel issues, discipline and termination of MSLs Review and approve expense reports; monitor compliance with expense...
for approved, in-development, and active Company-sponsored trials and/or investigator-sponsored research studies and serve.... Consistent adherence to field and corporate policies and Global Medical Scientific Affairs (GMSA) strategy, including field...
Clinical Study team, ensuring the scientific relevance of the clinical data. He/she will have to interact with Global Project... Head, The PV Rep, Regulatory and other key functional reps We are an innovative global healthcare company...
of data generation including supporting BMS-sponsored medical-led trials and book of work related to investigator sponsored... plans, in coordination with the Global Medical Affairs and other cross-functional teams. Represent US Medical Affairs...
opportunities which prepare students for success in a global society. Essential functions (job duties): Perform laboratory based..., ensuring compliance with all legal, regulatory and protocol guidelines. Assist staff with experiments/research protocols...
Institute (DHVI) continues to lead cutting-edge vaccine research against infectious diseases that impact global health. Basic... repertoire studies. Manage recombinant antibody production and purification. Laboratory Safety and Compliance: Understand...
and other study related documents, and complete study documents/case report forms. Ensure compliance with research protocols.... Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct. Ensure...
initiation and development of Investigator Research proposals (IRs). The Senior MSL must possess in-depth knowledge of BioMarin... Global Medical Affairs (GMAF) organization. Based on therapeutic needs and product life cycles, the MSL team will focus...
to the Global Project Head Interacts with the other CRDs in the project, as well as with the Global Project Head...…) We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re...
, the at The University of Texas at Austin has been a global leader in technology innovation and engineering education... investigator or senior research personnel to obtain research funding from federal agencies and industry. Help maintain laboratory...
FWA department policies and procedures to ensure compliance with federal and State regulations and make enhancement... of business processes and systems to assure integrity and compliance in billing and claims payment. Develop educational materials...
Megatrials domain designs and operationalizes large global commercial clinical trials focused on evaluating new drugs/devices... for regulatory approval. The team works directly with senior clinical and operational Executives at large global pharmaceutical...
Travel Percentage: Up to 25% Compensation Range: $62,900.00 - $94,400.00 The compensation range provided is in compliance... or other related matters, completing risk assessments, and reviewing other related compliance tasks. RESPONSIBILITIES: Support...