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Regulatory Disclosures Coordinator

Business Type: Pharmaceutical Company
Job Type: Regulatory Affairs
Job Level: Experienced (non manager)
Position: Contract
Location: Hertfordshire
Reference: sd-disclosures
Closing Date: 13/04/20
Job Details:
Regulatory Disclosures Coordinator

I am working with a top pharmaceutical company in Hertfordshire who is looking for a Regulatory Disclosures Coordinator to join them on a 6-month contract.

The company is looking for someone to ensure that Regulatory Disclosures meets all the applicable regulatory requirements for posting study information onto, EudraCT, and the EU PAS registry. The department generates and presents information that meets the needs of health authorities, patients, purchasers and prescribers for Roche''s global Pharma Medicines Division, which includes all therapeutic areas and all phases of product development from early development to post-marketing.

Some of your responsibilities will include:
*Support the accurate and timely posting of company trial protocols and study results on relevant internal and external websites.
*Supporting activities that include, but are not limited to, taking meeting minutes, data entry for study results, engagement with stakeholders to manage review/approval timelines, quality checks of redacted documents.
*Taking group meeting minutes
*Data entry in support of the registration, maintenance, and results for, EudraCT, and EU PAS registries
*Provide regulatory disclosures expertise to cross-functional teams and other groups
*Tracks missing/late registry entries and Clinical Study Reports (CSRs)

The company is looking for someone who has:
*BSc Degree in life sciences
*Experience in the pharmaceutical/ biotechnology industry
*Previous experience in regulatory affairs
*Medical writing/ editing experience
*Must be familiar with clinical development, CFR protocols and able to explain phase 1, 2, 3 intervention and outcomes measures

This is an urgent role for the company so if you are interested in discussing this role further then please feel free to get in touch with Sabrina Deo at or call 07824452641

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Posted: 06/04/2020 | NPJ Ref: 252771
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