Job Description Summary The Global Program Regulatory Manager (GPRM) works with some independence under limited... supervision to provide strategic and operational regulatory direction and may support the RA global program team (GPT...
Job Description Summary The Global Program Regulatory Manager (GPRM) works with some independence under limited... supervision to provide strategic and operational regulatory direction and may support the RA global program team (GPT...
Development Plans (IDP), clinical data review, program specific standards, clinical components of regulatory documents.../registration dossiers, and publications Leading development of clinical sections of trial and program level regulatory documents...
books, clinical study reports, etc.) and/or a large, complex trial, under the leadership of the Global Program Clinical Head... clinical development plan (CDP), data review, program specific standards, clinical components of regulatory documents...
a people manager, a program lead, or both. You will lead cross-functional collaboration within and outside AQS and decision... programming activities for multiple clinical trials within a program or an indication /disease area, or development program...
of trial and program level regulatory documents Driving execution of the assigned clinical program and/or clinical trial..., where applicable Support the Global Program Clinical Head (GPCH) in ensuring overall safety of the molecule for the assigned section...
of trial and program level regulatory documents Driving execution of the assigned clinical program and/or clinical trial..., where applicable Support the Global Program Clinical Head (GPCH) in ensuring overall safety of the molecule for the assigned section...
and contribute to clinical sections of trial and program level regulatory documents (e.g., investigator’s brochures, briefing books... development of clinical study report, publications and internal/external presentations Support the Global Program Clinical Head...