(FDA, EMA) on outsourcing and oversight obligations, proactively shaping EMP's process framework ahead of compliance risk...
any/all of the following equipment: Microsoft 365 apps, fax, email, phone, Klara, EMA, ModMed, iPAD, NoahFace (biometric timeclock...
of cGMP regulations (FDA 21 CFR Parts 210/211, ICH guidelines, EMA requirements). Exceptional organizational, communication...
by NASW code of ethics, HIPPA and Atlanta EMA Case Management Standards to ensure a high level of professionalism...
comply with cGMP, FDA, EMA, and global regulatory requirements Support regulatory filings, supplements, and responses...
and integration with Rave. Knowledge of clinical trial processes, ICH E6 GCP guidelines, and regulatory requirements (FDA, EMA...
, utilities, and systems comply with cGMP and global regulatory requirements, including FDA, EMA, and ISO standards. The... standards, including FDA, EMA, and ISO. Demonstrated experience with validation documentation, including authoring...
FDA/EMA guidance for gene and cell therapies. Direct experience contributing to CMC sections of regulatory filings...
, orders, EMA reports, and other deadlines. · Performs other administrative, docket management, document generation, mail...
[EMA;e.g., MetricWire platform] and/or statistical software [e.g., R]), and supervisory experience are highly desirable...