Associate II, Manufacturing
Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility...
Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility...
; (i.e. have led successful interactions with the FDA, EMA and other health authorities, including a filing.) You have extensive...
, EMA and MHRA regulations and guidelines regarding GCP, GLP and GVP activities Excellent verbal and written communication...
for Good Clinical Practice), GCLP (EMA, WHO Good Clinical Laboratory Practice), ISO13485, and/or related laws, regulations...
Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility...
, clinical development and medical writing.) Strong working knowledge of FDA, EMA regulations and expectations, Good Clinical...
regulatory requirements, including FDA, EMA, MHRA, and other major regulatory authorities. Knowledge of the CRO landscape...
is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved...
manufacturing facilities: The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP...
Knowledge of applicable safety regulations (FDA, EMA, ICH, CIOMS, GCP and other regulatory guidelines. Includes knowledge...