This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. As a SSU you will be responsible for the independent preparation, review and approval of country related submission packages in accordance with ICH, GCP and all applicable regulations, laws and other guidelines and ethical standards Also responsible for the independent preparation, review and approval of site level critical documents for Investigational Product (IP) release in accordance with regulatory/sponsor requirements – within specific timelines and quality standards. Developing and finalizing Master and Country Specific Information Sheets/Informed Consent Forms (SIS/ICFs)...
De linkedin corporation - Hace 33 minutoshttp://bit.ly/1eBaXmp
