Regulatory Writer – Horsham, UK

A Regulatory Writer is required to join a regulatory affairs consultancy company based in Horsham, UK.

Reporting to the Operations Director of Regulatory Affairs, as a Regulatory Writer, your main responsibilities will include:

  • Regulatory and medical writing activities in accordance with the project brief in a timely, accurate and efficient manner to the highest of standards.
  • Attending project initiation meetings and taking project briefs.
  • Liaising within freelancers and other external resources as required.
  • Liaising with all team members to ensure timely QC and completion of all documents.
  • Maintaining awareness of current practice in medical writing, medical information techniques and applicable regulatory guidelines.

Preparation of documents such as:

  • Clinical Study reports
  • Investigator brochures
  • All components of CTD
  • Clinical expert statements and case narratives.
  • Single evaluation and issue workups.
  • Benefit-Risk ration assessments.

The ideal candidate for this Regulatory Writer job will have the following skills and experience:

  • Previous experience in medical / regulatory writing essential.
  • Knowledge of the drug development process and applicable regulatory guidelines will be beneficial.
  • Customer focused approach.
  • Excellent written and oral communication skills.
  • Good attention to detail.
  • Ability to work ina team.

 

Apply Now

For more information or to apply for this Regulatory Writer job, please contact Meera Pattni on  +44 (0)1438 743047  or email mpattni@ckclinical.co.uk.

Alternatively, click here to apply for this Regulatory Writer job online now.

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