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Job Details

Global Data Quality and Standards Regulatory Operations Manager

Company: Regulatory Professionals
Location:
Reference: J25269
Closing Date: 05 Jan 17
Type: Full Time
Salary (£): On Application
Benefits: Flexible dependant on candidate + Benefits

Job Summary:

Top 20 pharma company based in Hertfordshire is currently looking for a Regulatory professionals who have had exposure to clinical disclosure documents. Successful candidate will be working in the Reg Ops department in a team which has a clear structure for career progression.

Requirements:

Is Clinical Disclosure an up and coming area you want to work in?
Do you want to be a part of a company that takes care of its employees and provides flexible working?

Job title: Global Data Quality and Standards Regulatory Operations Manager

Job type - Permanent

Salary - Flexible dependant on candidate + Benefits

Locations - Hertfordshire

Job Reference Number: J25269

The Company
A top 20 pharmaceutical company based in Hertfordshire is currently looking for a Regulatory professionals who have had exposure to clinical disclosure documents. The successful candidate will be working in the Regulatory Operations department in a team which has a clear structure for career progression.

Responsibilities
* You will support the establishment of a new team within DQ&S (currently comprising 1.5 FTEs besides the DQ&S Manager).
* Supervise the new clinical trials transparency team within DQ&S and develop procedures for the team's operation
* Drive the activities for EudraCT results disclosure of old studies to ensure deadlines are met
* Ensure the companies knowledge of clinical trial transparency obligations is current at all times and reflected in appropriate procedural documents
* Analyse existing procedures for gaps and drive improvements to enhance efficiency and timeliness of activities
* Coordinate with other departments in the company to ensure consistency of the overall study disclosure activities

Requirements
* Minimum of 6 years' experience in the pharmaceutical industry, preferably in regulatory affairs or clinical operations
* Good knowledge of clinical transparency rules such as FDAAA801, EudraCT, EMA Policy 70, PhRMA/EFPIA principles for data sharing, etc.
* Experience with study registration and disclosure on clinicaltrials.gov
* Track record of driving and successfully completing time-sensitive projects across multiple departments

If you are interested in this role please call Harry Brown on 01189 522797 to discuss further.

Remember if this role is not suitable for you or you are no longer looking for a new job please feel free to forward this to anyone you feel would be suitable. If we successfully find a role for your recommendation we will give you £250 in vouchers of your choice.

Keywords: Regulatory, Professionals. Hertfordshire, Essex, North, East, West, London, Buckinghamshire, Middlesex, MAA, CTA, NCE, EU, Senior, Manager, Global, Lead, Disclosure, Clinical Trials, Clinical Disclosure, Clinical Transparency, Medical Writer, Medical Writing

Apply for this job: Global Data Quality and Standards Regulatory Operations Manager

Contact Information:

Address:  UK Office
3rd floor 33 Blagrave Street Reading
RG1 1LG
England
Tel:  +44 (0)118 9522 797
Website:  Visit Our Web Site

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