Sr. Director, Quality Assurance
Clinical Quality Assurance strategy to ensure compliance with international regulatory requirements (e.g., FDA, EMA, ICH GCP...
Clinical Quality Assurance strategy to ensure compliance with international regulatory requirements (e.g., FDA, EMA, ICH GCP...
authority. Experience and Skills: Required: 8+ years working in an FDA/EMA regulated environment. Bachelor’s degree...
directly with agencies (e.g., FDA, EMA, PMDA). Hands-on experience with a broad range of quantitative and computational tools...
, FDA, EMA, and ICH Guidelines through meticulous review processes. Verify analytical data meets ALCOA+ principles...
. On average, physicians see 35 patients per day, with the help of clinical assistants and support staff. The practice utilizes the EMA...
, commercial, HMO) EClinicalWorks, EMA, or other EMR software Exciting Perks: 40% off products and procedures, as well as the...
., FDA, EMA, WHO, MHRA). Ensure compliance with Good Distribution Practices (GDP) and other applicable quality standards...
in clinical development, at FDA/EMA level. Drive interaction with external policy groups in collaboration with Regulatory...
Support Lead preparation for FDA, EMA, and other global agency interactions on CMC topics. Review briefing package..., EMA, and international regulatory guidelines related to biologics and ADC products. Ensure compliance with global...
per provider EMA / EMR software in place An Established Practice with Room to Grow This practice has built its reputation...