based in Irvine, CA reporting to the Director, PDS&T Toxins. Responsibilities: Manage the protein characterization group... assessment and relevant characterization studies (e.g., forced degradation study, and protein structure elucidation...
on , , , , and . Job Description Reporting to the Director and International Brand Team Leader of T/Epkinly, International Marketing and Commercial Operations... and compliance guidelines are followed. Relates scientific detail and clinical study outcomes to impactful communication strategies...
Life, Reva and David Logan Center for the Arts, the Library and Institute for the Study of Ancient Cultures. Court... of Chicago, and the local and national theatre community, including Court’s own staff, freelance technicians, and guest artists...
improvements using metrics and stakeholder feedback, coordinating with the Director to ensure consistency across the DF/HCC.... Stakeholder Liaison and Consortium Coordination: Serve as an operational liaison to various DF/HCC research offices and study...
Medicine Biomarker team at Clinical trial study teams (CST) and Biomarker/OTM Matrix teams. As part of the CST, establishing... of contact for resolving study biomarker issues. Collaborate with clinical operations and sample management to ensure biomarker...
(for an indication or for multiple studies within an indication) from study start up through to regulatory submission. In collaboration... with cross-functional teams, external partners, and support Data Managers, may serve as the lead study data manager for a large...
. Serve as the point of escalation for the COMs for issues that can’t be resolved at the study level. Collaborate with COMs...+ years’ experience in pharmaceutical industry and/or clinical research organization, including 7+ years clinical study...
of clinical study designs, analysis methodology and data interpretation. Advanced knowledge of pharmaceutical industry, overall... and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the...
this expertise to enable very complex study designs driven by advanced randomization schemes, complex sourcing strategies, automated... inventory methodologies, and data flow requirements. Key Responsibilities: Study Setup process management and oversight...
development and drug safety systems Work with contract auditors and CQA management to develop study specific audit plans Review... by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification...
. Demonstrated independent analytical and problem-solving abilities. Full understanding of regulatory requirements of study types... or veteran status, or any other characteristic protected by federal, state, or local laws. It is unlawful in some states...
in Life Sciences, Engineering, Marketing, Business, Finance, or related field of study; or High School Degree/General... to disability, protected veteran status, and any other status protected by applicable local, state, or federal law. To view the...
resource within own discipline or as technical functional teams or projects. Ensure all study management activities... will be completed in accordance with SOPs/WI, local regulatory guidance including ICH-GCP; audit leadership- interviewee & responses...
SUMMARY/JOB PURPOSE: Leads statistical programming activities at the study or project level. Uses statistical... develop SAS or other programs, and specifications, for use in study or other analyses, such as Integrated Safety Summaries...
Manage and mentor junior staff, providing guidance in experimental design and overseeing/helping with study execution..., or any other characteristics protected under applicable federal, state and local laws. ImmunEdge will make reasonable accommodations for qualified...
for IND/NDA/BLA/MAA, briefing documents, regulatory responses, protocols, investigator brochures, clinical study reports... as needed. Serves as the primary writing contact on regular and ad hoc study/program/asset or project teams. Provides writing guidance...
progress/update to the Global Study Associate Director/ Global Study Team including SMM Lead. Contributes to patient... Local Study Team(s) at country level ensuring compliance with Procedural Documents, ICH-GCP and local regulations. Ensures...
progress/update to the Global Study Associate Director/ Global Study Team including SMM Lead. Contributes to patient... Local Study Team(s) at country level ensuring compliance with Procedural Documents, ICH-GCP and local regulations. Ensures...
Overview The Director of Federal Aid (Associate Director in HR information system) reports to the Executive Director..., customer service, willingness to learn and acquire new skills, and commitment to deadlines. Responsibilities The Director...
Overview: The Director of Federal Aid (Associate Director in HR information system) reports to the Executive Director..., customer service, willingness to learn and acquire new skills, and commitment to deadlines. Responsibilities: The Director...