TRABAJO SITE START UP REGULATORY

Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations • identify regulatory complexity and challenges and offer...

Position: regulatory information associate, regulatory operations & systems managementlocation: madrid (on site)experience: 3 to 5 years’ experience in regulatory...

Sr manager, study start up icon plc is a world-leading healthcare intelligence and clinical research organization... we are currently seeking a senior manager, study...

Study teams) to support timely completion of both drug and non-drug program goals and objectives generate and provide accurate and up-to-date project status and...

· regulatory compliance (change control, post-approval activities, etc... )· interactions with key business partners and regulatory authorities· launch or supply...

Manage site inspections carried out by regulatory agencies... manage the retention of the ehs required documentation in the site ehs files...

Organizes regulatory information, logs and tracking... maintains regulatory files/database and chronologies in good order... participate in the product development...

Everyday blends operational focus, regulatory problem-solving, and cross-functional coordination... focus: site start-up & regulatory submissions across all divisions...

Manage site inspections carried out by regulatory agencies...    maintain follow up activities with field technicians at least biweekly...   manage any on site incidents/accidents...

Ensures timely submission of application/documents to ec/irb at start up and for the duration of the study... coordinates the site selection process by identifying...

Contribute to quality site selection through participation in site feasibility ensuring consistent conduct of site qualification visits and appropriate follow-up...

Support escalation of quality/cgmp issues and deficiencies to the site qa head and support global escalation process if needed... about the role major accountabilities:...

• contribute to data collection to support the site selection process... this service supports the gtl in leading related cro, country, and site activities, including...

\u contribute to data collection to support the site selection process... this service supports the gtl in leading related cro, country, and site activities, including...

Achieves ppd’s target cycle times for site... key-contact at country level for either ethical or regulatory submission-related activities...

Job title:study start up lead location: uk, spain, poland, bulgaria, netherlands (fully homebased) fully sponsor dedicated   as a study start up manager, you...

Executes regulatory agency inspection readiness activities (e... maintains expert country, site and protocol knowledge to support sites with questions as well as...