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Regulatory Disclosures Co-ordinator - Welwyn Garden City

Business Type: Pharmaceutical Company
Job Type: Regulatory Affairs
Job Level: Management
Position: Full Time
Salary: GBP190 - GBP225 per day
Location: Hertfordshire
Reference: km/dc
Closing Date: 01/04/20
Job Details:
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, 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 -

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.

Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities. By applying for this position you agree to our privacy policy which can be found here:

Posted: 25/03/2020 | NPJ Ref: 252327
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