systems (including EMA), a strong operational backbone and leadership that understands what it takes to build a sustainable..., 401(k) with employer match and generous PTO Streamlined workflow using EMA and a well-trained clinical team that lets...
in managing SOPs, change controls, and regulated documentation Experience supporting FDA, EMA, or other regulatory inspections...
(ICH, FDA, EMA), cGMPs, and Quality/Compliance expectations for the development of parenteral biologics and gene therapy vectors...
and adapting them to meet evolving regulatory and business needs Act as direct liaison with agencies such as the US FDA and EMA...
patient history, visit reason, medications, and patient understanding of procedures, and make notes in EMA. Ensuring MIPS...) EClinicalWorks, EMA, or other EMR software Exciting Perks: 40% off products and procedures, as well as the ability to participate...
are obtained, with no delays to market entries. Actively participates and interfaces directly/indirectly with the FDA, EMA, MHRA...
any/all of the following equipment: Microsoft 365 apps, fax, email, phone, Klara, EMA, ModMed, iPAD, NoahFace (biometric timeclock...
. Strong working knowledge of ICH-GCP, FDA, EMA, GDP, GMP, and applicable regulations for clinical supply and IMP distribution...
technical advice to individuals within the team Thorough working knowledge of US FDA CFRs and European EMA, including...
approaches for equipment and systems qualification. Experience supporting regulatory inspections, including FDA, EMA, and MHRA...