for a pharmaceutical organization. Ensure compliance with industry regulations (FDA, EMA, GMP), drive process standardization, and enable...
, and aseptic small molecule production to ensure compliance with FDA, EMA, and other regulatory bodies. Review and approve... resolution. Host and facilitate audits from regulatory authorities (e.g., FDA, EMA) and clients, preparing documentation...
Responsibilities: Act as a superuser for the EMA ModMed system, providing guidance to both providers and medical assistants...
with FDA, EMA, and other regulatory bodies. Review and approve facility, utility and equipment CQV documentation such as URS...
(e.g. GxP, ISO, ICH, Annex 1, etc.) across multiple health authorities (e.g. FDA, EMA, MHRA, etc.). Extensive...
, EMA, and ICH guidelines. Ability to extract and document rules/logic for technical teams. Strong QC capabilities...
compliance with FDA, EMA, and other regulatory bodies. Review and approve facility, utility and equipment CQV documentation...
â— Knowledgeable with insurance carriers (i.e., Medicare, commercial, HMO) â— EClinicalWorks, EMA, or other EMR software Exciting...
with regulatory pathways (FDA, EMA) and trial registries (e.g., ) ALS-TDI is an equal opportunity employer. We celebrate diversity...
the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200...