Regulatory Disclosures Manager – 12 month contract – Welwyn Garden City
Major global pharmaceutical organisation in Hertfordshire requires a regulatory Disclosures Co-ordinator to join their team on an initial 12 month contract.
In this role, you will be responsible for the accurate and timely postings of trial protocols and study results on the relevant internal and external websites including ClinicalTrials.gov, EudraCT and the EU PAS registry. You will be responsible for ensuring that regulatory Disclosures meet all the applicable regulatory requirements.
Other responsibilities will include:
– contributing to the development and maintenance of policies and SOPs on clinical trial registry and clinical trial results database.
– identifying studies required for registry and results posting,
– tracking missing or late registry entries and CSR
– reporting and analysis
– summarise clinical trials into data and tables
– sharing information with the general public – clinicaltrials.gov
To be suitable for this role, you will have:
– BSc preferably in life sciences
– 3 or more years’ experience in pharma or biotech industry across phases I-II
– medical writing and/or editing experience
– understanding of international regulations, process and issues in drug development, including GxP, GCP, ICH etc
– good understanding of clinical study reports and protocol designs
– excellent communication skills
If this role sounds of interest, then please forward your CV to arrange an initial telephone conversation.
Job Reference: Km/dc_1574163047
Broadcast As: 190
Salary Currency: GBP
Salary From: 24
Salary To: 28
Salary per: Hourly
Job Type: Full Time
Job Term: Contract
Job Industry: Pharmaceutical
Job Specialism: Regulatory Affairs
Recruitment Consultant: Kerry McDaid