Regulatory Submissions Publisher (12 Month Contract)

Sandwich, Kent

£14.00 - £15.52 per hour


About the Regulatory Submissions Publisher:

Our client, a global pharmaceutical manufacturing organisation located in Sandwich, is currently looking to recruit a Regulatory Submissions Publisher to create document packages using a number of build and publishing tools.

The submissions packages are compiled in paper and/or electronic format with documentation received from Department Managers and are then submitted to Regulatory agencies (often within very tight timelines) to seek clinical trial and/or marketing authorisation approval for pharmaceutical products.

This is a 37 hour per week role, paying a rate of £14.00 to £15.52 per hour depending on experience.


Duties and Responsibilities:

* Responsible for building, publishing, archiving activities and associated tasks for assigned Regulatory submissions within agreed timelines.
* Adhering to quality control procedures and standards related to submission publishing.
* Adhering to the appropriate use of document management systems, publishing and validation tools, through the use of working practices and quality control steps to ensure Regulatory compliance.
* Support other team members with submission workload when necessary to provide flexible support for the submissions portfolio.
* Responsible for key projects within a specific geographical region to implement and train on any external agency updates for procedures or requirements
* Monitoring local mailbox for any urgent publishing requests and assigning to resources available within geographical regions.
* Support global/local teams publishing teams when the need arises
* Adhere to compliance standards.


Person Specification:

* Computer literacy in MS Word/Outlook/Excel/Adobe Acrobat.
* Experience of using various publishing tools such as ISI Publisher and proven knowledge of eCTD formats.
* Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards.
* Functional and technical knowledge and skills to do the job at a high level of accomplishment.


About Morgan Jones:

This role is being handled by Morgan Jones Recruitment Consultants. We have been established as a quality recruitment business for over 16 years with a reputation for fair and equal representation.

We see each applicant as an individual and will treat you accordingly.

We would love to talk to you to give you more information about our client and discuss the role.

To view other great opportunities please check out our website or call us on 0808 168 1474 for a confidential chat about upcoming opportunities.

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Due to the high volume of applicants applying for all roles, we can only reply to candidates with the most relevant skills and experience. If you have not heard back from us within 48 hours of your application, please assume that you have been unsuccessful on this occasion.