Clinical Submission Specialist (Associate - Lead levels) - UK- Fully remote - Freelance 6 months
Advanced Resource Managers are currently actively looking for Clinical Submission Specialist candidates in the UK to join a leading level CRO within the long standing Regulatory Team based In the UK. Having placed a number of candidates into this team, we are well placed to give you an overview of what it would be like working in this team and the development opportunities our client can give you.
Main duties you will be covering are as follows –
· Prepare, review and coordinate, under guidance, local regulatory submissions
· Provide guidance local regulatory strategy advice to various sponsors
· Key-contact at country level for either Ethical or Regulatory submission-related activities
· Working with the clinical team to prepare the regulatory compliance review packages
· Ensure the local country study files and filing processes are prepared
To be considered for this role, you must hold the following -
· Bachelor's degree
· 1 - 5 years clinical experience or equivalent combination of education, training, & experience
· Effective oral and written communication skills
· Excellent interpersonal skills
· Basic medical/therapeutic area and medical terminology knowledge
· Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations.
If you are interested in hearing more about this opportunity, please email ruby.willard@arm-talent.com for more details.