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Regulatory Publishing Specialist

  1. Any EMEA Location, UK
2024-110888
  1. Medical Writing
  2. ICON Strategic Solutions
  3. Remote

About the role

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As a Regulatory Publishing Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

 

As a Regulatory Publishing Specialist you will be fully dedicated to a Top-5 pharmaceutical company. While working for our client, you will be able to profit from ICON through continued learning opportunities and building a longer-term career.

 

This role is home based in the UK or Europe


What you will be doing:

  • Compilation and publishing of clinical documents
  • Compile and publish all relevant clinical documents including but not limited to Clinical Trial Report (CTR) body and synopsis, CTR appendices, Investigator’s Brochures (IB), Non intervention Study Reports (NSRs), Lay summaries, submission documents and Q&A documents
  • Perform additional processing of published documents (e.g. add cross-references/hyperlinks) to ensure that the published documents are compliant with all relevant internal and external requirements to PDF files intended for regulatory submissions.
  • Ensure finalisation of documents
  • Coordinate and ensure quality of CTR appendix material
  • Plan and coordinate the collection of appendix material in collaboration with the medical writer, study group and local affiliates
  • Check appendix documentation and ensure adherence to internal and regulatory publishing standards (e.g. regarding navigation, bookmarks, hyperlinks, margins, header).
  • Ensure electronic quality control (eQC) of all clinical documents intended for regulatory submissions

You are:

  • MSc., or equivalent
  • Experience in regulatory publishing in CRO or pharma
  • Experience in the routine use of Document Management Systems,
  • Adobe Acrobat, Professional and MS tools



Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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