Senior Regulatory Publishing Specialist in London

  • Salary: Competitive
  • REF Number: 00045575
  • Consultant: Andy Leake
  • Contact: 01438 842 966
  • Date Published: 19.06.2019
  • Sector: Non-Specific
  • Location: South East, London
  • Discipline: Regulatory Affairs

Andy Leake at CK Clinical is recruiting for a Senior Regulatory Publisher to join a large global CRO on a contract basis until the end of the year.

This role is located in Central London and the site is easily commutable from London and surrounding areas. Some home working is available.

The Role:

Your main duties will be to:

  • Provide publishing and submission support in the development of global Regulatory submissions.
  • Directly communicate project specifics to internal and external clients and organise, compile and publish documents and submissions for regulatory deliverables.
  • Act as primary publisher for all worldwide regulatory submission types e.g. electronic, paper according to SOPs and within established timeframe's requiring no technical direction as well as setting submission strategy for complex solutions.

Further responsibilities will include:

  • Providing oversight to strategic planning and publishing timeframes required for a specific submission and promoting submission publishing efficiencies by promoting re-use of documents, adopting global dossier principles and standardising processes to enable simultaneous compilation and publication of submissions.
  • Collaborating with other submission publishers to assure standard practices and quality submission outcomes, participating in multi-discipline work streams as publishing subject matter expert and educating document authors on technical submission formats, lifecycle management and regional submission requirements.
  • Acting as submission coordinator on project teams for functional or cross-functional submissions of high complexity and performing Quality Control review of submission component documents to client and regulatory agency specifications.

The ideal candidate for this role will have:

  • Educated to degree level or above in Life Science or a related field.
  • Extensive background in global publishing including eCTD, NeeS and paper submissions.
  • In depth knowledge of regulations governing pharmaceutical document submissions and excellent skills in the use of electronic submission publishing tools and/or document management systems.
  • Excellent communication, interpersonal and time management skills and the ability to work autonomously under limited direction.

For more information or to apply for this position, please contact Andy Leake on 014378 842966 or email Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45575 in all correspondence.

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