, and client feedback, ensuring contractual and operational expectations are met or exceeded. Ensure compliance with FDA, EMA... of pharmacovigilance experience. 5+ years of client-facing project leadership experience. Strong knowledge of FDA, EMA, ICH, and global...
(IND) applications and clinical trial protocols. Ensure compliance with regulatory standards (FDA, EMA, etc.) during the...
, ICH guidelines, and other applicable regulatory guidance documents, global PV regulatory environment, EMA regulations...
(EMA) is a plus. Bilingual in English and Spanish preferred. Work environment and physical requirements: Normal work...
Experienced support staff, including dedicated medical assistants providing scribing support User-friendly EMA electronic medical...
Flexibility to tailor scheduling and patient flow to your preferred practice style Modern EMA / EMR platform Join an established...
understanding of global regulatory processes (FDA, EMA, Health Authorities).Experience supporting regulatory submissions...
management. Strong working knowledge of applicable FDA, EMA, ICH, pharmacopeial, and global cGMP expectations for biologics...
, neuroscience, rare disease, or sleep-wake disorder programs Familiarity with FDA, EMA, and ICH regulatory requirements Experience...
any/all of the following equipment: Microsoft 365 apps, fax, email, phone, Klara, EMA, ModMed, iPAD, NoahFace (biometric timeclock...